ME NewsWire / Business Wire
TOKYO - Wednesday, October 30th 2013
Toshiba Corporation (TOKYO:6502) today announced that it has launched a new series of ARM Cortex™-M4F-core-based TX04 series microcontrollers, “TMPM462F15FG”, “TMPM462F10FG”, “TMPM461F15FG” and “TMPM461F10FG”, for motor control applications in equipment such as multifunction printers (MFP) and printers. Sample shipments will start in November this year, with mass production scheduled to start in spring 2014.
The development of highly sophisticated motor control applications for equipment such as MFPs and printers requires much more software code, and that in turn creates a requirement for microcontrollers with large-capacity memory, multiple communication channels, and interfaces with high-resolution sensors.
The new microcontrollers integrate a maximum of 1.5Mbyte flash ROM, 193Kbyte SRAM, 20 serial interface channels, and a 20-channel high-resolution 12-bit A/D converter. This secures motor control with a single microcontroller, without any need for external memory and I/O expander ICs, lowering materials requirements and costs. Integration of a large-capacity memory increases data transfer rates, improving processing performance.
The product line-up offers different memory sizes and pin counts, allowing selection to meet system requirements.
To view the main specifications kindly click here
About Toshiba
Toshiba is a world-leading diversified manufacturer, solutions provider and marketer of advanced electronic and electrical products and systems. Toshiba Group brings innovation and imagination to a wide range of businesses: digital products, including LCD TVs, notebook PCs, retail solutions and MFPs; electronic devices, including semiconductors, storage products and materials; industrial and social infrastructure systems, including power generation systems, smart community solutions, medical systems and escalators & elevators; and home appliances.
Toshiba was founded in 1875, and today operates a global network of more than 590 consolidated companies, with 206,000 employees worldwide and annual sales surpassing 5.8 trillion yen (US$61 billion). Visit Toshiba's web site at www.toshiba.co.jp/index.htm
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20131029007287/en/
To view the full release including the table, please click here
Contacts
Media Inquiries:
Toshiba Corporation
Semiconductor & Storage Products Company
Takashi Mochizuki, +81-3-3457-4963
semicon-NR-mailbox@ml.toshiba.co.jp
Permalink: http://www.me-newswire.net/news/9016/en
Thursday, October 31, 2013
ZTE Celebrates Success of Its Blade Series and Reveals the ZTE Blade Q Range
ME Newswire / Business Wire
SHENZHEN, China - Wednesday, October 30th 2013
ZTE unveils the ZTE Blade Q range including the ZTE Blade Q Mini, ZTE Blade Q and ZTE Blade Q Maxi
The Blade series has been one of most popular smartphone series with millions of devices sold globally
ZTE Blade III, ZTE Blade III Pro, ZTE Blade V and ZTE Blade G now on sale in 23 countries across Europe
ZTE today reveals the ZTE Blade Q range following the success of its previous Blade products in Europe. The ZTE Blade Q range will join one of the most popular series of smartphones in Europe, with the ZTE Blade III, ZTE Blade III Pro, ZTE Blade V and ZTE Blade G already available in 23 countries in the region.
Mr. AO Wen, General Manager of ZTE Handset European Operation Office, said, “At ZTE we believe that smartphone technology should be accessible for everyone. The popularity of the Blade series across Europe proves that there is real consumer appetite for high performance smartphones at a great price. The features available across the Blade handsets redefine ‘value for money’ in the smartphone market, and we’re confident that the ZTE Blade Q range will continue to grow ZTE’s position in Europe.”
With such a positive response from customers across Europe for the Blade series, the ZTE Blade Q range has been designed with their wishes at the heart. To answer consumer desire for both larger and smaller devices, the ZTE Blade Q range will be the first of the Blade handsets available in three formats; the ZTE Blade Q Mini which offers a compact and efficient device with a 4” screen; the ZTE Blade Q which offers superb design with a 4.5” screen and the ZTE Blade Q Maxi which features a large and bright 5” screen. All screens feature IPS screen technology that prevents screen picture distortion and allows 178º viewing.
ZTE has designed the Blade series to offer more power for its price than competitors and the ZTE Blade Q will be no exception. The ZTE Blade Q range is defined not only by great design but by powerful performance with all devices featuring a dual-core 1.3 GHz processor, 1GB RAM and 21 MB/s HSPA+ connectivity to provide a seamless and effortless experience for browsing the internet, downloading music and apps, streaming videos and music, playing online games and much more.
Like popular predecessors in the Blade series, including the ZTE Blade III, ZTE Blade V and ZTE Blade G, the ZTE Blade Q range boast a 5 MP camera with auto-focus and flash, and a panoramic shooting mode to capture the perfect picture. The ZTE Q range is ready to go straight out of the box, with an array of must-have Google services, popular cloud services like Evernote and Dropbox and a top office suite pre-installed.
Key specifications of the ZTE Blade Q series
ZTE Blade Q Mini specifications:
Operating system:
Android 4.2 Jelly Bean
Size:
125.5x63.9x8.9mm
Display:
4’ WVGA (480x800Pixel)
Camera:
5 megapixel camera with AF/ Flash
Network:
GSM 900/1800/1900 MHz
UMTS 900/2100 MHz
Battery:
1500 mAh
Processor:
1.3 GHz dual core MTK processor
Memory:
1GB RAM, 4GB ROM intern memory
Other:
GPS, WiFi 802.11 abgn, Bluetooth 4.0
Mobile Hotspot, HD voice, dual microphone for noise reduction, FM radio
ZTE Blade Q specifications:
Operating system:
Android 4.2 Jelly Bean
Size and weight:
135x67x9.5mm
Display:
4.5’ FWVGA (480x854Pixel)
Camera:
5 megapixel camera with AF/ Flash
0.3 megapixel front camera
Network:
GSM 900/1800/1900 MHz
UMTS 900/2100 MHz
Battery:
1800 mAh Lithium-Ion battery
Processor:
1.3 GHz dual core MTK processor
Memory:
1GB RAM, 4GB ROM intern memory
Other:
GPS, WiFi 802.11 abgn, Bluetooth 4.0
Mobile Hotspot, HD voice, dual microphone for noise reduction, FM radio
ZTE Blade Q Maxi specifications:
Operating system:
Android 4.2 Jelly Bean
Size and weight:
143x72x9.1mm
Display:
5’ FWVGA (480x854Pixel)
Camera:
5 megapixel camera with AF/ Flash
0.3 megapixel front camera
Network:
GSM 900/1800/1900 MHz
UMTS 900/2100 MHz
Battery:
2000 mAh
Processor:
1.3 GHz dual core MTK processor
Memory:
1GB RAM, 4GB ROM intern memory
Other:
GPS, WiFi 802.11 abgn, Bluetooth 4.0
Mobile Hotspot, HD voice, dual microphone for noise reduction, FM radio
About ZTE Mobile Devices
ZTE Mobile Devices is a division of ZTE Corporation, a global telecommunications equipment, networks and mobile devices company headquartered in Shenzhen, China. ZTE is a publicly traded company listed on the Hong Kong and Shenzhen stock exchanges.
ZTE is one of the Top 5 mobile handset and smartphone manufacturers in the world, according to global industry analyst IDC. The company produces a complete range of mobile devices, including mobile phones, tablets, mobile broadband modems and hotspots and family desktop integration terminals.
A global leader, ZTE has partnerships with more than 230 major carriers and distributors in over 160 countries and regions around the globe. It also has strategic partnerships with 47 of the world’s top 50 carriers. In 2012, ZTE applied for more international patents than any other company in the world.
For more information, please visit: www.ztedevices.com.
Contacts
ZTE Europe
Sheila Wang, +44 20 3428 2014
sheila.wang@zte.com.cn
Hotwire PR for ZTE
Josh Wheeler, +44 (0) 207 608 4689
zteeuhub@hotwirepr.com
Permalink: http://me-newswire.net/news/9027/en
SHENZHEN, China - Wednesday, October 30th 2013
ZTE unveils the ZTE Blade Q range including the ZTE Blade Q Mini, ZTE Blade Q and ZTE Blade Q Maxi
The Blade series has been one of most popular smartphone series with millions of devices sold globally
ZTE Blade III, ZTE Blade III Pro, ZTE Blade V and ZTE Blade G now on sale in 23 countries across Europe
ZTE today reveals the ZTE Blade Q range following the success of its previous Blade products in Europe. The ZTE Blade Q range will join one of the most popular series of smartphones in Europe, with the ZTE Blade III, ZTE Blade III Pro, ZTE Blade V and ZTE Blade G already available in 23 countries in the region.
Mr. AO Wen, General Manager of ZTE Handset European Operation Office, said, “At ZTE we believe that smartphone technology should be accessible for everyone. The popularity of the Blade series across Europe proves that there is real consumer appetite for high performance smartphones at a great price. The features available across the Blade handsets redefine ‘value for money’ in the smartphone market, and we’re confident that the ZTE Blade Q range will continue to grow ZTE’s position in Europe.”
With such a positive response from customers across Europe for the Blade series, the ZTE Blade Q range has been designed with their wishes at the heart. To answer consumer desire for both larger and smaller devices, the ZTE Blade Q range will be the first of the Blade handsets available in three formats; the ZTE Blade Q Mini which offers a compact and efficient device with a 4” screen; the ZTE Blade Q which offers superb design with a 4.5” screen and the ZTE Blade Q Maxi which features a large and bright 5” screen. All screens feature IPS screen technology that prevents screen picture distortion and allows 178º viewing.
ZTE has designed the Blade series to offer more power for its price than competitors and the ZTE Blade Q will be no exception. The ZTE Blade Q range is defined not only by great design but by powerful performance with all devices featuring a dual-core 1.3 GHz processor, 1GB RAM and 21 MB/s HSPA+ connectivity to provide a seamless and effortless experience for browsing the internet, downloading music and apps, streaming videos and music, playing online games and much more.
Like popular predecessors in the Blade series, including the ZTE Blade III, ZTE Blade V and ZTE Blade G, the ZTE Blade Q range boast a 5 MP camera with auto-focus and flash, and a panoramic shooting mode to capture the perfect picture. The ZTE Q range is ready to go straight out of the box, with an array of must-have Google services, popular cloud services like Evernote and Dropbox and a top office suite pre-installed.
Key specifications of the ZTE Blade Q series
ZTE Blade Q Mini specifications:
Operating system:
Android 4.2 Jelly Bean
Size:
125.5x63.9x8.9mm
Display:
4’ WVGA (480x800Pixel)
Camera:
5 megapixel camera with AF/ Flash
Network:
GSM 900/1800/1900 MHz
UMTS 900/2100 MHz
Battery:
1500 mAh
Processor:
1.3 GHz dual core MTK processor
Memory:
1GB RAM, 4GB ROM intern memory
Other:
GPS, WiFi 802.11 abgn, Bluetooth 4.0
Mobile Hotspot, HD voice, dual microphone for noise reduction, FM radio
ZTE Blade Q specifications:
Operating system:
Android 4.2 Jelly Bean
Size and weight:
135x67x9.5mm
Display:
4.5’ FWVGA (480x854Pixel)
Camera:
5 megapixel camera with AF/ Flash
0.3 megapixel front camera
Network:
GSM 900/1800/1900 MHz
UMTS 900/2100 MHz
Battery:
1800 mAh Lithium-Ion battery
Processor:
1.3 GHz dual core MTK processor
Memory:
1GB RAM, 4GB ROM intern memory
Other:
GPS, WiFi 802.11 abgn, Bluetooth 4.0
Mobile Hotspot, HD voice, dual microphone for noise reduction, FM radio
ZTE Blade Q Maxi specifications:
Operating system:
Android 4.2 Jelly Bean
Size and weight:
143x72x9.1mm
Display:
5’ FWVGA (480x854Pixel)
Camera:
5 megapixel camera with AF/ Flash
0.3 megapixel front camera
Network:
GSM 900/1800/1900 MHz
UMTS 900/2100 MHz
Battery:
2000 mAh
Processor:
1.3 GHz dual core MTK processor
Memory:
1GB RAM, 4GB ROM intern memory
Other:
GPS, WiFi 802.11 abgn, Bluetooth 4.0
Mobile Hotspot, HD voice, dual microphone for noise reduction, FM radio
About ZTE Mobile Devices
ZTE Mobile Devices is a division of ZTE Corporation, a global telecommunications equipment, networks and mobile devices company headquartered in Shenzhen, China. ZTE is a publicly traded company listed on the Hong Kong and Shenzhen stock exchanges.
ZTE is one of the Top 5 mobile handset and smartphone manufacturers in the world, according to global industry analyst IDC. The company produces a complete range of mobile devices, including mobile phones, tablets, mobile broadband modems and hotspots and family desktop integration terminals.
A global leader, ZTE has partnerships with more than 230 major carriers and distributors in over 160 countries and regions around the globe. It also has strategic partnerships with 47 of the world’s top 50 carriers. In 2012, ZTE applied for more international patents than any other company in the world.
For more information, please visit: www.ztedevices.com.
Contacts
ZTE Europe
Sheila Wang, +44 20 3428 2014
sheila.wang@zte.com.cn
Hotwire PR for ZTE
Josh Wheeler, +44 (0) 207 608 4689
zteeuhub@hotwirepr.com
Permalink: http://me-newswire.net/news/9027/en
Lenovo Names Ashton Kutcher Its Newest Product Engineer
LOS ANGELES - Wednesday, October 30th 2013 [ME NewsWire]
(BUSINESS WIRE)-- Multimode computing leader Lenovo (SEHK:0992) (Pink Sheets:LNVGY) today announced a new partnership with Ashton Kutcher at the livestream launch event of the new Yoga Tablet, held at the Youtube Space LA. In his new role as a Lenovo product engineer, Kutcher will work with the company’s engineering teams around the world to develop and market the Yoga line of tablets by providing input and decision-making into design, specifications, software and usage scenarios.
“This partnership with Lenovo brings together my love of technology and design that makes your life better. I can’t wait to dig in and help Lenovo develop future mobile computing products, starting with the Yoga Tablet,” said Ashton Kutcher. “Lenovo is all about innovation and strong leadership. Entrepreneurship is part of their DNA, and I couldn’t ask for a better fit.”
Kutcher currently stars in the CBS comedy, Two and a Half Men, which airs worldwide. He has also gained significant recognition for his technology investments over the past several years and is a co-founder of A-Grade Investments, which has provided venture capital and collaboration for multiple tech companies including Airbnb, Fab, Foursquare, Spotify, Path and Uber.
“Ashton Kutcher’s authentic, creative appetite for technology and keen consumer insight combined with our innovation engine make this a very natural and powerful partnership,” said David Roman, chief marketing officer, Lenovo. “This partnership goes beyond traditional bounds by deeply integrating him into our organization as a product engineer as we look at developing the next wave of products. As we continue to push into new PC Plus product areas and lead in multimode computing, Ashton will help us break new ground by challenging assumptions, bringing new perspective and contributing his technical expertise to Yoga Tablet and other devices.”
The new multimode Yoga Tablet gives people a better way to get the most out of their tablet experience with up to 18 hours of battery life1 and with its three unique modes: hold, tilt and stand. Recognizing that one size doesn’t fit all, Lenovo created the three modes to solve the common challenges that tablet users face. The Yoga Tablet’s cylindrical handle breaks the mold on “sea of sameness” tablet design, allowing users to more easily hold the tablet to read and browse the Internet, deploy the stand to sit it upright on a surface to watch movies and tilt the tablet down on a surface for a better viewing angle for touchscreen typing and reading.
Financial terms of the multi-year partnership are not being disclosed.
For the latest Lenovo news, subscribe to Lenovo RSS feeds or follow Lenovo on Twitter and Facebook. Also follow news about the Yoga Tablet at #betterway. The press kit is available at: http://news.lenovo.com/betterway.
About Lenovo
Lenovo (SEHK:0992) (Pink Sheets:LNVGY) is a US$34 billion personal technology company – the largest PC maker worldwide and an emerging PC Plus leader – serving customers in more than 160 countries. Dedicated to exceptionally engineered PCs and mobile internet devices, Lenovo’s business is built on product innovation, a highly-efficient global supply chain and strong strategic execution. Formed by Lenovo Group’s acquisition of the former IBM Personal Computing Division, the Company develops, manufactures and markets reliable, high-quality, secure and easy-to-use technology products and services. Its product lines include legendary Think-branded commercial PCs and Idea-branded consumer PCs, as well as servers, workstations, and a family of mobile internet devices, including tablets and smart phones. Lenovo, a global Fortune 500 company, has major research centers in Yamato, Japan; Beijing, Shanghai and Shenzhen, China; and Raleigh, North Carolina. For more information see www.lenovo.com.
About Ashton Kutcher
Ashton Kutcher is an actor, entrepreneur, tech investor, producer and philanthropist. Kutcher can currently be seen weekly on the CBS comedy, Two and a Half Men. In 2011, Kutcher co-created a venture fund, A-Grade Investments, with Ron Burkle and Guy Oseary. To date, A-Grade has invested in multiple tech companies including Airbnb, Flipboard, Foursquare, Path, Quora, Shazam, SoundCloud, Spotify, The Fancy, and Uber. As a philanthropist, Kutcher co-created Thorn: Digital Defenders of Children (www.wearethorn.org). Thorn invests in, builds and deploys the latest technology as part of the ongoing fight to end child sexual exploitation. In 2010, Kutcher was named one of Time Magazine's Top 100 Most Influential People. In that same year, his company, Katalyst, was named one of the year's Top 50 Most Inspiring Innovators by Ad Age and one of Fast Company Magazine’s Top 10 Most Innovative Companies. In 2011, Vanity Fair named Kutcher to their 2011 New Establishment List, which identifies the top 50 of an innovative new breed of buccaneering visionaries, engineering prodigies and entrepreneurs.
1Actual battery life may vary based on many factors including screen brightness, active applications, features, power management settings, battery age and conditioning, and other customer preferences. Testing consisted of full battery discharge while performing each of the following tasks: two hours of video playback plus two hours of mp3 audio playback in Stand-by Mode plus two hours of Internet browsing using Wi-Fi in Tilt Mode plus twelve hours of reading in Hold Mode.
Contacts
Global Communications, Lenovo
Kristy Fair, 919-257-6329
krisfair@lenovo.com
Permalink: http://www.me-newswire.net/news/9013/en
(BUSINESS WIRE)-- Multimode computing leader Lenovo (SEHK:0992) (Pink Sheets:LNVGY) today announced a new partnership with Ashton Kutcher at the livestream launch event of the new Yoga Tablet, held at the Youtube Space LA. In his new role as a Lenovo product engineer, Kutcher will work with the company’s engineering teams around the world to develop and market the Yoga line of tablets by providing input and decision-making into design, specifications, software and usage scenarios.
“This partnership with Lenovo brings together my love of technology and design that makes your life better. I can’t wait to dig in and help Lenovo develop future mobile computing products, starting with the Yoga Tablet,” said Ashton Kutcher. “Lenovo is all about innovation and strong leadership. Entrepreneurship is part of their DNA, and I couldn’t ask for a better fit.”
Kutcher currently stars in the CBS comedy, Two and a Half Men, which airs worldwide. He has also gained significant recognition for his technology investments over the past several years and is a co-founder of A-Grade Investments, which has provided venture capital and collaboration for multiple tech companies including Airbnb, Fab, Foursquare, Spotify, Path and Uber.
“Ashton Kutcher’s authentic, creative appetite for technology and keen consumer insight combined with our innovation engine make this a very natural and powerful partnership,” said David Roman, chief marketing officer, Lenovo. “This partnership goes beyond traditional bounds by deeply integrating him into our organization as a product engineer as we look at developing the next wave of products. As we continue to push into new PC Plus product areas and lead in multimode computing, Ashton will help us break new ground by challenging assumptions, bringing new perspective and contributing his technical expertise to Yoga Tablet and other devices.”
The new multimode Yoga Tablet gives people a better way to get the most out of their tablet experience with up to 18 hours of battery life1 and with its three unique modes: hold, tilt and stand. Recognizing that one size doesn’t fit all, Lenovo created the three modes to solve the common challenges that tablet users face. The Yoga Tablet’s cylindrical handle breaks the mold on “sea of sameness” tablet design, allowing users to more easily hold the tablet to read and browse the Internet, deploy the stand to sit it upright on a surface to watch movies and tilt the tablet down on a surface for a better viewing angle for touchscreen typing and reading.
Financial terms of the multi-year partnership are not being disclosed.
For the latest Lenovo news, subscribe to Lenovo RSS feeds or follow Lenovo on Twitter and Facebook. Also follow news about the Yoga Tablet at #betterway. The press kit is available at: http://news.lenovo.com/betterway.
About Lenovo
Lenovo (SEHK:0992) (Pink Sheets:LNVGY) is a US$34 billion personal technology company – the largest PC maker worldwide and an emerging PC Plus leader – serving customers in more than 160 countries. Dedicated to exceptionally engineered PCs and mobile internet devices, Lenovo’s business is built on product innovation, a highly-efficient global supply chain and strong strategic execution. Formed by Lenovo Group’s acquisition of the former IBM Personal Computing Division, the Company develops, manufactures and markets reliable, high-quality, secure and easy-to-use technology products and services. Its product lines include legendary Think-branded commercial PCs and Idea-branded consumer PCs, as well as servers, workstations, and a family of mobile internet devices, including tablets and smart phones. Lenovo, a global Fortune 500 company, has major research centers in Yamato, Japan; Beijing, Shanghai and Shenzhen, China; and Raleigh, North Carolina. For more information see www.lenovo.com.
About Ashton Kutcher
Ashton Kutcher is an actor, entrepreneur, tech investor, producer and philanthropist. Kutcher can currently be seen weekly on the CBS comedy, Two and a Half Men. In 2011, Kutcher co-created a venture fund, A-Grade Investments, with Ron Burkle and Guy Oseary. To date, A-Grade has invested in multiple tech companies including Airbnb, Flipboard, Foursquare, Path, Quora, Shazam, SoundCloud, Spotify, The Fancy, and Uber. As a philanthropist, Kutcher co-created Thorn: Digital Defenders of Children (www.wearethorn.org). Thorn invests in, builds and deploys the latest technology as part of the ongoing fight to end child sexual exploitation. In 2010, Kutcher was named one of Time Magazine's Top 100 Most Influential People. In that same year, his company, Katalyst, was named one of the year's Top 50 Most Inspiring Innovators by Ad Age and one of Fast Company Magazine’s Top 10 Most Innovative Companies. In 2011, Vanity Fair named Kutcher to their 2011 New Establishment List, which identifies the top 50 of an innovative new breed of buccaneering visionaries, engineering prodigies and entrepreneurs.
1Actual battery life may vary based on many factors including screen brightness, active applications, features, power management settings, battery age and conditioning, and other customer preferences. Testing consisted of full battery discharge while performing each of the following tasks: two hours of video playback plus two hours of mp3 audio playback in Stand-by Mode plus two hours of Internet browsing using Wi-Fi in Tilt Mode plus twelve hours of reading in Hold Mode.
Contacts
Global Communications, Lenovo
Kristy Fair, 919-257-6329
krisfair@lenovo.com
Permalink: http://www.me-newswire.net/news/9013/en
New Research Identifies Competitive Advantages for London and Other European Cities
The Global Cities Initiative and Centre for London bring Europe's leaders together to discuss growth strategies for the region's cities LONDON - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE)-- New research published today by the Global Cities Initiative and Centre for London to underscore a landmark Conference, finds that despite the impact of recent economic crises, European cities maintain competitive advantages over new megacities in other parts of the world. However, as the world economy continues to evolve, Europe’s cities – those that are already established 'global cities' as well as those that seek to become more global – must come up with new ways to be more globally competitive.
The research in the paper, 'Europe’s Cities in a Global Economy', assesses recent trends in city-related performance, as measured in over 100 quantitative and perception-led studies. It identifies where the continent’s cities remain strong, which cities appear to be adapting to new global business demand and which factors are critical to the revitalization of Europe’s cities in the next phase of globalization.
The Global Cities Initiative and the Centre for London commissioned this research, which will be discussed with European city leaders at the London Conference 2013 today. City leaders from Moscow, Oslo, Poznan and Amsterdam, amongst others, will meet to discuss ways to increase the region’s global competitiveness at the third annual London Conference, which will open with an address by Lord Sebastian Coe.
“Cities have long been vital to trade, innovation, and the economic health of a given region. In today’s global economy, competition is fierce and the ability for metropolitan regions to be globally competitive is critical to their success,” said Emilio Saracho, J.P. Morgan's Deputy CEO of EMEA. “Europe’s cities must continue to re-orient, innovate and find ways to build global fluency. Today’s discussions will help us do just that.”
The majority of European cities have maintained important infrastructure, human capital and sustainability advantages over other global regions. Many of Europe’s mid-sized cities record healthy scores for entrepreneurship, multi-lingual talent, quality of life and regional connectivity that are not easily replicable elsewhere. European cities are also very well placed to serve new economic centers and emerging market firms as they increasingly make investments and expand into developed countries.
European cities can increase these advantages by deepening relationships with emerging economies. Opportunities include lucrative new visitor and student markets, co-operation in health and environment sectors and design, engineering and consultancy solutions for infrastructure projects.
"For centuries Europe's cities led the world. But with the Asia, Africa and South America urbanising fast, urban momentum is moving South. If London and the major European cities are to retain their competitive edge, and provide for their citizens, they will need to reform their economies, while continuing to invest in infrastructure and quality of life. We are thrilled to be working with the Global Cities Initiative on this year's London Conference. It provides an important chance for London and other European cities to take stock, and learn from other cities, and engage with city leaders and experts from around the world."
Also published for the Conference is the international version of 'Ten Traits of Globally Fluent Metropolitan Areas', which provides an important framework for city leaders to review their growth strategies. Successful traits include adaptability to global dynamics, international connectivity and the ability to secure investment for strategic priorities.
To read the full reports or learn more about the conversations, visit londonconference2013.com.
ABOUT CENTRE FOR LONDON
Centre for London is a new think tank focused on helping London, one of the oldest and most important world cities, meet its challenges and build on its great strengths. Launched two years ago, the Centre is quickly developing relations with sister organisations across Europe. Centre for London has held two previous London Conferences in 2011 and 2012. The London Conference 2013 will be the third in the series. The Centre publishes research and thinking on the city’s issues and holds numerous events throughout the year. See the full programme of work here.
ABOUT THE GLOBAL CITIES INITIATIVE
Launched in 2012, the Global Cities Initiative (GCI) is a five-year effort aimed at helping city and metropolitan leaders become more globally fluent by providing an in-depth and data-driven look at their regional standing on crucial global economic measures, highlighting best policy and practice innovations from around the world, and creating an international network of leaders who ultimately trade and grow together. GCI combines the Brookings Institution’s deep expertise in fact-based, metropolitan-focused research and J.P. Morgan’s longstanding commitment to investing in cities, helping to equip leaders by unveiling economic starting points on such key indicators as advanced manufacturing, exports, foreign direct investment, freight flow and immigration. For more information please visit www.jpmorganchase.com/globalcities.
Contacts
J.P. Morgan
Jennifer Zuccarelli
jennifer.r.zuccarelli@jpmorgan.com
020-7134-8504
Centre for London
Jess Tyrrell
jess.tyrrell@centreforlondon.co.uk
020-3102-3767
Permalink: http://me-newswire.net/news/9011/en
(BUSINESS WIRE)-- New research published today by the Global Cities Initiative and Centre for London to underscore a landmark Conference, finds that despite the impact of recent economic crises, European cities maintain competitive advantages over new megacities in other parts of the world. However, as the world economy continues to evolve, Europe’s cities – those that are already established 'global cities' as well as those that seek to become more global – must come up with new ways to be more globally competitive.
The research in the paper, 'Europe’s Cities in a Global Economy', assesses recent trends in city-related performance, as measured in over 100 quantitative and perception-led studies. It identifies where the continent’s cities remain strong, which cities appear to be adapting to new global business demand and which factors are critical to the revitalization of Europe’s cities in the next phase of globalization.
The Global Cities Initiative and the Centre for London commissioned this research, which will be discussed with European city leaders at the London Conference 2013 today. City leaders from Moscow, Oslo, Poznan and Amsterdam, amongst others, will meet to discuss ways to increase the region’s global competitiveness at the third annual London Conference, which will open with an address by Lord Sebastian Coe.
“Cities have long been vital to trade, innovation, and the economic health of a given region. In today’s global economy, competition is fierce and the ability for metropolitan regions to be globally competitive is critical to their success,” said Emilio Saracho, J.P. Morgan's Deputy CEO of EMEA. “Europe’s cities must continue to re-orient, innovate and find ways to build global fluency. Today’s discussions will help us do just that.”
The majority of European cities have maintained important infrastructure, human capital and sustainability advantages over other global regions. Many of Europe’s mid-sized cities record healthy scores for entrepreneurship, multi-lingual talent, quality of life and regional connectivity that are not easily replicable elsewhere. European cities are also very well placed to serve new economic centers and emerging market firms as they increasingly make investments and expand into developed countries.
European cities can increase these advantages by deepening relationships with emerging economies. Opportunities include lucrative new visitor and student markets, co-operation in health and environment sectors and design, engineering and consultancy solutions for infrastructure projects.
"For centuries Europe's cities led the world. But with the Asia, Africa and South America urbanising fast, urban momentum is moving South. If London and the major European cities are to retain their competitive edge, and provide for their citizens, they will need to reform their economies, while continuing to invest in infrastructure and quality of life. We are thrilled to be working with the Global Cities Initiative on this year's London Conference. It provides an important chance for London and other European cities to take stock, and learn from other cities, and engage with city leaders and experts from around the world."
Also published for the Conference is the international version of 'Ten Traits of Globally Fluent Metropolitan Areas', which provides an important framework for city leaders to review their growth strategies. Successful traits include adaptability to global dynamics, international connectivity and the ability to secure investment for strategic priorities.
To read the full reports or learn more about the conversations, visit londonconference2013.com.
ABOUT CENTRE FOR LONDON
Centre for London is a new think tank focused on helping London, one of the oldest and most important world cities, meet its challenges and build on its great strengths. Launched two years ago, the Centre is quickly developing relations with sister organisations across Europe. Centre for London has held two previous London Conferences in 2011 and 2012. The London Conference 2013 will be the third in the series. The Centre publishes research and thinking on the city’s issues and holds numerous events throughout the year. See the full programme of work here.
ABOUT THE GLOBAL CITIES INITIATIVE
Launched in 2012, the Global Cities Initiative (GCI) is a five-year effort aimed at helping city and metropolitan leaders become more globally fluent by providing an in-depth and data-driven look at their regional standing on crucial global economic measures, highlighting best policy and practice innovations from around the world, and creating an international network of leaders who ultimately trade and grow together. GCI combines the Brookings Institution’s deep expertise in fact-based, metropolitan-focused research and J.P. Morgan’s longstanding commitment to investing in cities, helping to equip leaders by unveiling economic starting points on such key indicators as advanced manufacturing, exports, foreign direct investment, freight flow and immigration. For more information please visit www.jpmorganchase.com/globalcities.
Contacts
J.P. Morgan
Jennifer Zuccarelli
jennifer.r.zuccarelli@jpmorgan.com
020-7134-8504
Centre for London
Jess Tyrrell
jess.tyrrell@centreforlondon.co.uk
020-3102-3767
Permalink: http://me-newswire.net/news/9011/en
Thuraya SatSleeve Wins Lloyd's List Innovation Award
Unique device that converts an iPhone to a satellite smartphone honored at prestigious maritime awards ceremony
DUBAI, United Arab Emirates - Wednesday, October 30th 2013 [ME NewsWire]
Thuraya Telecommunications Company, a leading Mobile Satellite Services (MSS) operator, has been named winner of the Innovation Award at the Lloyd’s List Middle East and Indian Subcontinent 2013 Awards.
Thuraya won the award for the Thuraya SatSleeve, its unique satellite adaptor for the iPhone that enables maritime and offshore users to stay connected from remote locations outside of terrestrial networks with their iPhone. The award judges recognized the SatSleeve’s ability to keep seafarers in touch with their loved ones as well as facilitating vital business communications for officers and crew when operating outside coverage of terrestrial networks.
In selecting Thuraya for the award, the judging panel noted: “The winner of this highly competitive award has created what has been described as the missing link in crew and business communications at sea. As such, this company has improved the quality of life for seafarers immeasurably, helping them keep in contact with their families, friends and colleagues from anywhere on the globe”.
Samer Halawi, Chief Executive Officer of Thuraya said, “We are delighted to have won this award, which recognizes Thuraya’s commitment to developing products and services that truly meet the needs of mobile users. Combining the innovation of Thuraya’s mobile satellite products with the intuitive interface of the iPhone, the SatSleeve provides an elegant and cost effective way to keep in touch while at sea.”
Compatible with iPhone 4/4S and 5/5S, the Thuraya SatSleeve supports voice calls, SMS and basic data connectivity in satellite mode. Users can pre-program an SOS number into the Thuraya SatSleeve to contact a nominated first responder – a feature that works even without the iPhone connected.
The SatSleeve can be used across the Thuraya network either with a Thuraya SIM card in 140 countries or with a standard GSM SIM card available from 356 worldwide GSM operators across more than 160 countries.
About Thuraya Telecommunications Company
Thuraya Telecommunications Company is an industry leading MSS operator and a global telecommunication provider offering innovative communications solutions to a variety of sectors including energy, broadcast media, maritime, military and humanitarian NGO. Visit www.thuraya.com
Contacts
Thuraya
Shereen Hanafi, Director of Communications
+971-4-4488-888
corporatecomms@thuraya.com
Follow Thuraya on: Facebook, LinkedIn, Twitter and YouTube
Permalink: http://me-newswire.net/news/9014/en
DUBAI, United Arab Emirates - Wednesday, October 30th 2013 [ME NewsWire]
Thuraya Telecommunications Company, a leading Mobile Satellite Services (MSS) operator, has been named winner of the Innovation Award at the Lloyd’s List Middle East and Indian Subcontinent 2013 Awards.
Thuraya won the award for the Thuraya SatSleeve, its unique satellite adaptor for the iPhone that enables maritime and offshore users to stay connected from remote locations outside of terrestrial networks with their iPhone. The award judges recognized the SatSleeve’s ability to keep seafarers in touch with their loved ones as well as facilitating vital business communications for officers and crew when operating outside coverage of terrestrial networks.
In selecting Thuraya for the award, the judging panel noted: “The winner of this highly competitive award has created what has been described as the missing link in crew and business communications at sea. As such, this company has improved the quality of life for seafarers immeasurably, helping them keep in contact with their families, friends and colleagues from anywhere on the globe”.
Samer Halawi, Chief Executive Officer of Thuraya said, “We are delighted to have won this award, which recognizes Thuraya’s commitment to developing products and services that truly meet the needs of mobile users. Combining the innovation of Thuraya’s mobile satellite products with the intuitive interface of the iPhone, the SatSleeve provides an elegant and cost effective way to keep in touch while at sea.”
Compatible with iPhone 4/4S and 5/5S, the Thuraya SatSleeve supports voice calls, SMS and basic data connectivity in satellite mode. Users can pre-program an SOS number into the Thuraya SatSleeve to contact a nominated first responder – a feature that works even without the iPhone connected.
The SatSleeve can be used across the Thuraya network either with a Thuraya SIM card in 140 countries or with a standard GSM SIM card available from 356 worldwide GSM operators across more than 160 countries.
About Thuraya Telecommunications Company
Thuraya Telecommunications Company is an industry leading MSS operator and a global telecommunication provider offering innovative communications solutions to a variety of sectors including energy, broadcast media, maritime, military and humanitarian NGO. Visit www.thuraya.com
Contacts
Thuraya
Shereen Hanafi, Director of Communications
+971-4-4488-888
corporatecomms@thuraya.com
Follow Thuraya on: Facebook, LinkedIn, Twitter and YouTube
Permalink: http://me-newswire.net/news/9014/en
Rockwell Automation to Acquire vMonitor, a Global Technology Leader for Wireless Solutions Connecting the Digital Oilfield
ME Newswire / Business Wire
MILWAUKEE - Tuesday, October 29th 2013
Rockwell Automation, Inc. (NYSE: ROK) today announced that it has agreed to purchase vMonitor, a global technology leader for wireless solutions in the oil and gas industry.
vMonitor is a pioneer in Digital Oilfield implementation and remote operations worldwide. It delivers innovative monitoring and control solutions for wellhead and upstream applications that combine cutting-edge wireless instrumentation and communication with visualization software to help customers make more informed decisions and improve production.
vMonitor has the world’s largest installed base of wireless wellhead monitoring systems for natural and artificially lifted wells with more than 6,000 well sites for major oil and gas companies around the world.
“Strategically, vMonitor’s world class digital oilfield technology and services, combined with our comprehensive portfolio of solutions, strengthen our ability to deliver end-to-end projects for the oil and gas sector,” said Terry Gebert, vice president and general manager, Rockwell Automation Global Solutions.
“Equally important, vMonitor’s capabilities will accelerate our development of similar process solutions and remote monitoring services for water / wastewater, mining and other industries globally,” said Gebert.
“Our customers will benefit from Rockwell Automation’s global solutions capabilities and complementary product lines to ensure we can collectively provide a seamless integrated solution,” said Rashed Saif Al Suwaidi, chairman of vMonitor. “Our employees will also join an innovative, fast-growing technology leader serving the worldwide oil and gas industry.” vMonitor has about 120 employees at offices located in Houston, Mumbai, Abu Dhabi, and other Middle East locations.
The company’s technologies include an all-wireless portfolio of wellhead sensors and transmitters, remote terminal units, gateways and modems, as well as turn-key monitoring and control systems and services. These offerings cover a broad range of applications from oil and gas wells, pipelines, pumping and lift stations, to refineries and tank farms.
The acquisition is expected to close within two months. vMonitor will then become part of Rockwell Automation’s Control Products & Solutions operating segment.
Rockwell Automation will showcase vMonitor at its 2013 Automation Fair event to be held Nov. 13-14 in Houston, Texas, USA. Attendees will have the opportunity to view a control room simulation, a remote terminal unit, and packaged solutions.
Rockwell Automation, Inc. (NYSE: ROK), the world’s largest company dedicated to industrial automation and information, makes its customers more productive and the world more sustainable. Headquartered in Milwaukee, Wis., Rockwell Automation employs about 22,000 people serving customers in more than 80 countries.
Contacts
Rockwell Automation
Media Relations
John A. Bernaden, 414-382-2555
Rockwell Automation
Investor Relations
Rondi Rohr-Dralle, 414-382-8510
Permalink: http://me-newswire.net/news/8999/en
MILWAUKEE - Tuesday, October 29th 2013
Rockwell Automation, Inc. (NYSE: ROK) today announced that it has agreed to purchase vMonitor, a global technology leader for wireless solutions in the oil and gas industry.
vMonitor is a pioneer in Digital Oilfield implementation and remote operations worldwide. It delivers innovative monitoring and control solutions for wellhead and upstream applications that combine cutting-edge wireless instrumentation and communication with visualization software to help customers make more informed decisions and improve production.
vMonitor has the world’s largest installed base of wireless wellhead monitoring systems for natural and artificially lifted wells with more than 6,000 well sites for major oil and gas companies around the world.
“Strategically, vMonitor’s world class digital oilfield technology and services, combined with our comprehensive portfolio of solutions, strengthen our ability to deliver end-to-end projects for the oil and gas sector,” said Terry Gebert, vice president and general manager, Rockwell Automation Global Solutions.
“Equally important, vMonitor’s capabilities will accelerate our development of similar process solutions and remote monitoring services for water / wastewater, mining and other industries globally,” said Gebert.
“Our customers will benefit from Rockwell Automation’s global solutions capabilities and complementary product lines to ensure we can collectively provide a seamless integrated solution,” said Rashed Saif Al Suwaidi, chairman of vMonitor. “Our employees will also join an innovative, fast-growing technology leader serving the worldwide oil and gas industry.” vMonitor has about 120 employees at offices located in Houston, Mumbai, Abu Dhabi, and other Middle East locations.
The company’s technologies include an all-wireless portfolio of wellhead sensors and transmitters, remote terminal units, gateways and modems, as well as turn-key monitoring and control systems and services. These offerings cover a broad range of applications from oil and gas wells, pipelines, pumping and lift stations, to refineries and tank farms.
The acquisition is expected to close within two months. vMonitor will then become part of Rockwell Automation’s Control Products & Solutions operating segment.
Rockwell Automation will showcase vMonitor at its 2013 Automation Fair event to be held Nov. 13-14 in Houston, Texas, USA. Attendees will have the opportunity to view a control room simulation, a remote terminal unit, and packaged solutions.
Rockwell Automation, Inc. (NYSE: ROK), the world’s largest company dedicated to industrial automation and information, makes its customers more productive and the world more sustainable. Headquartered in Milwaukee, Wis., Rockwell Automation employs about 22,000 people serving customers in more than 80 countries.
Contacts
Rockwell Automation
Media Relations
John A. Bernaden, 414-382-2555
Rockwell Automation
Investor Relations
Rondi Rohr-Dralle, 414-382-8510
Permalink: http://me-newswire.net/news/8999/en
Wednesday, October 30, 2013
Oral Apremilast Monotherapy Demonstrated Long-Term Clinical Benefits in Psoriatic Arthritis Patients Naïve to Previous DMARD Therapy
BOUDRY, Switzerland - Tuesday, October 29th 2013 [ME NewsWire]
PALACE 4 achieves primary endpoint of ACR 20 at week 16 with nearly 60 percent of patients who completed 52 weeks on apremilast achieving an ACR 20 response
PALACE 4 is the first large randomized controlled study to examine the efficacy and safety of a novel agent in patients naïve to previous DMARD therapy
Long-term, clinically meaningful improvements seen in manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis
(BUSINESS WIRE)-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of its long-term phase III study on apremilast, the Company’s first-in-class oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic or biologic DMARD-naïve psoriatic arthritis patients at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
PALACE 4 is the first large, randomized, controlled study to examine the efficacy and safety of a novel agent exclusively in systemic or biologic DMARD-naïve psoriatic arthritis patients. Apremilast monotherapy demonstrated clinical benefits over 52 weeks in this treatment-naïve patient population, including clinically meaningful improvements in signs and symptoms of psoriatic arthritis, as well as manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis.
At week 16, a statistically significantly greater proportion of patients treated with apremilast monotherapy achieved a modified ACR20 (the study’s primary endpoint) versus placebo: 29.2% (apremilast 20 mg; P=0.0076) and 32.3% (apremilast 30 mg; P=0.0011) versus 16.9% (placebo). For those patients randomized to apremilast and completing 52 weeks of the study, an ACR20 response of 53.4% (apremilast 20 mg) and 58.7% (apremilast 30 mg) at week 52 was observed. ACR 50 and 70 was reached by 31.9% and 18.1% of patients, respectively, for apremilast 30 mg.
“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naïve psoriatic arthritis patients,” said Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, US. “These encouraging results suggest that apremilast may have the potential to be used alone and as a first-line therapy.”
Durable improvements in multiple endpoints—including enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (swelling of a finger or toe), impaired physical function as assessed by HAQ-DI, swollen and tender joint counts and associated skin psoriasis—were maintained or increased in patients completing 52 weeks of treatment.
Apremilast monotherapy demonstrated an acceptable safety profile and was generally well-tolerated up to 52 weeks. No new safety concerns were identified with longer treatment duration, and the profile was consistent with previously reported safety data on apremilast. The most common adverse events (AEs) reported through 52 weeks were nausea, diarrhea and headache. Discontinuation rates for diarrhea and nausea in the combined apremilast treatment groups were less than 2% over 52 weeks. No serious AEs of diarrhea or nausea were reported in any treatment group up to 52 weeks. No systemic opportunistic infections, including no cases of tuberculosis (new or reactivations), were reported.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
About PALACE Program
PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent active treatment phase up to 52 weeks followed by a long-term safety phase in which all patients are treated with apremilast. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically appearing placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2, 3 and 4 studies is the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at weeks 16 and 24.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. An estimated 125 million people worldwide have psoriasis, approximately 30 percent of whom may also develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common signs and symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Celgene International Sàrl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8979/en
PALACE 4 achieves primary endpoint of ACR 20 at week 16 with nearly 60 percent of patients who completed 52 weeks on apremilast achieving an ACR 20 response
PALACE 4 is the first large randomized controlled study to examine the efficacy and safety of a novel agent in patients naïve to previous DMARD therapy
Long-term, clinically meaningful improvements seen in manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis
(BUSINESS WIRE)-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results of its long-term phase III study on apremilast, the Company’s first-in-class oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in systemic or biologic DMARD-naïve psoriatic arthritis patients at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
PALACE 4 is the first large, randomized, controlled study to examine the efficacy and safety of a novel agent exclusively in systemic or biologic DMARD-naïve psoriatic arthritis patients. Apremilast monotherapy demonstrated clinical benefits over 52 weeks in this treatment-naïve patient population, including clinically meaningful improvements in signs and symptoms of psoriatic arthritis, as well as manifestations of psoriatic arthritis such as physical function (HAQ-DI), skin (PASI-75/50), swollen and tender joints, enthesitis and dactylitis.
At week 16, a statistically significantly greater proportion of patients treated with apremilast monotherapy achieved a modified ACR20 (the study’s primary endpoint) versus placebo: 29.2% (apremilast 20 mg; P=0.0076) and 32.3% (apremilast 30 mg; P=0.0011) versus 16.9% (placebo). For those patients randomized to apremilast and completing 52 weeks of the study, an ACR20 response of 53.4% (apremilast 20 mg) and 58.7% (apremilast 30 mg) at week 52 was observed. ACR 50 and 70 was reached by 31.9% and 18.1% of patients, respectively, for apremilast 30 mg.
“In addition to maintaining its long-term safety and tolerability profile consistent with the previously reported data, apremilast monotherapy showed significant clinical benefit in systemic or biologic DMARD-naïve psoriatic arthritis patients,” said Alvin Wells, M.D., Ph.D., Director, Rheumatology and Immunotherapy Center, Franklin, WI, US. “These encouraging results suggest that apremilast may have the potential to be used alone and as a first-line therapy.”
Durable improvements in multiple endpoints—including enthesitis (inflammation at sites where tendons, ligaments or joint capsule fibers insert into bone), dactylitis (swelling of a finger or toe), impaired physical function as assessed by HAQ-DI, swollen and tender joint counts and associated skin psoriasis—were maintained or increased in patients completing 52 weeks of treatment.
Apremilast monotherapy demonstrated an acceptable safety profile and was generally well-tolerated up to 52 weeks. No new safety concerns were identified with longer treatment duration, and the profile was consistent with previously reported safety data on apremilast. The most common adverse events (AEs) reported through 52 weeks were nausea, diarrhea and headache. Discontinuation rates for diarrhea and nausea in the combined apremilast treatment groups were less than 2% over 52 weeks. No serious AEs of diarrhea or nausea were reported in any treatment group up to 52 weeks. No systemic opportunistic infections, including no cases of tuberculosis (new or reactivations), were reported.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
About PALACE Program
PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent active treatment phase up to 52 weeks followed by a long-term safety phase in which all patients are treated with apremilast. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically appearing placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2, 3 and 4 studies is the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at weeks 16 and 24.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. An estimated 125 million people worldwide have psoriasis, approximately 30 percent of whom may also develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common signs and symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Celgene International Sàrl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8979/en
New data show Striverdi® (olodaterol)* Respimat® improves exercise tolerance in patients with moderate to very severe COPD1
• Data add to evidence from on-going Phase III clinical trial programme showing that once-daily olodaterol Respimat® provided fast, remarkable and sustained improvements in lung function in patients with moderate to very severe COPD2,3,4,5
ME NewsWire/ Business Wire
CHICAGO - Tuesday, October 29th 2013
For media outside the UK, U.S. and Canada
The latest data from Phase III studies show that treatment with once-daily olodaterol Respimat® resulted in statistically significant improvements in the amount of time that patients with chronic obstructive pulmonary disease (COPD) could exercise before breathlessness forced them to stop.
All patients involved in the studies had COPD with moderate to very severe lung function impairment, as defined by the GOLD guidelines.
What does this mean for the patient?
Reduced exercise tolerance is a common symptom of COPD and often worsens over time, limiting patients’ ability to do routine activities.6,7
“Exercise is an essential component of COPD management – people living with COPD who exercise regularly have improved breathing, less severe symptoms and a better quality of life,” said Dr François Maltais, MD, of the Research Center, Québec University Institute of Cardiology and Pneumology, Laval University, Québec, Canada.
“These study findings are important because we see that the bronchodilator effect of olodaterol can also lead to meaningful improvements in the level of exercise that patients with COPD can undertake – a very important consideration in their holistic care,” Dr Maltais added.
Data from the two replicate 6-week studies showed that, compared to usual care, treatment with olodaterol Respimat® improved airflow limitation which translated into reduced lung hyperinflation during exercise producing improvements in symptom-limited exercise tolerance.1 At Week 6, the exercise endurance time for patients receiving olodaterol Respimat® in Study 1222.37 was 14 percent greater than in the group of patients receiving usual care, and 12 percent greater than usual care in Study 1222.38.1
Usual care included short-acting anticholinergics (SAMAs), inhaled corticosteroids (ICS) and xanthines. Long-acting anticholinergics (LAMAs) were not permitted.
These data are presented for the first time at the 2013 American College of Chest Physicians (ACCP) annual meeting (CHEST 2013) in Chicago.
“These studies serve as another example of Boehringer Ingelheim’s commitment to advancing the treatment of COPD to address the unmet needs of millions of patients living with this devastating disease. We also look forward to results from our Phase III ANHELTO® studies evaluating the efficacy and safety of a free combination of tiotropium and olodaterol which are due to be reported in early 2014,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
Olodaterol Respimat® is both a fast-acting and long-lasting bronchodilator for the maintenance treatment of patients with COPD.
It has been shown in Phase III studies to deliver significant bronchodilator effects within 5 minutes after the first dose3 and provides sustained improvement in lung function over 24 hours that results in clinically meaningful improvements in patients’ quality of life.8
Please click on the link for ‘Notes to Editors’ and ‘References’: http://bit.ly/17pNWPQ
* Striverdi® (olodaterol) Respimat® is approved for use in COPD in the UK, Canada, Denmark, Iceland and Russia. Approval and regulatory reviews by health authorities in the US and other countries worldwide are pending.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20131029006025/en/
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Linda Calandra, + 49 151 15 02 11 48
Fax: +49 6132 – 77 6601
press@boehringer-ingelheim.com
www.boehringer-ingelheim.com
Permalink: http://www.me-newswire.net/news/9012/en
ME NewsWire/ Business Wire
CHICAGO - Tuesday, October 29th 2013
For media outside the UK, U.S. and Canada
The latest data from Phase III studies show that treatment with once-daily olodaterol Respimat® resulted in statistically significant improvements in the amount of time that patients with chronic obstructive pulmonary disease (COPD) could exercise before breathlessness forced them to stop.
All patients involved in the studies had COPD with moderate to very severe lung function impairment, as defined by the GOLD guidelines.
What does this mean for the patient?
Reduced exercise tolerance is a common symptom of COPD and often worsens over time, limiting patients’ ability to do routine activities.6,7
“Exercise is an essential component of COPD management – people living with COPD who exercise regularly have improved breathing, less severe symptoms and a better quality of life,” said Dr François Maltais, MD, of the Research Center, Québec University Institute of Cardiology and Pneumology, Laval University, Québec, Canada.
“These study findings are important because we see that the bronchodilator effect of olodaterol can also lead to meaningful improvements in the level of exercise that patients with COPD can undertake – a very important consideration in their holistic care,” Dr Maltais added.
Data from the two replicate 6-week studies showed that, compared to usual care, treatment with olodaterol Respimat® improved airflow limitation which translated into reduced lung hyperinflation during exercise producing improvements in symptom-limited exercise tolerance.1 At Week 6, the exercise endurance time for patients receiving olodaterol Respimat® in Study 1222.37 was 14 percent greater than in the group of patients receiving usual care, and 12 percent greater than usual care in Study 1222.38.1
Usual care included short-acting anticholinergics (SAMAs), inhaled corticosteroids (ICS) and xanthines. Long-acting anticholinergics (LAMAs) were not permitted.
These data are presented for the first time at the 2013 American College of Chest Physicians (ACCP) annual meeting (CHEST 2013) in Chicago.
“These studies serve as another example of Boehringer Ingelheim’s commitment to advancing the treatment of COPD to address the unmet needs of millions of patients living with this devastating disease. We also look forward to results from our Phase III ANHELTO® studies evaluating the efficacy and safety of a free combination of tiotropium and olodaterol which are due to be reported in early 2014,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
Olodaterol Respimat® is both a fast-acting and long-lasting bronchodilator for the maintenance treatment of patients with COPD.
It has been shown in Phase III studies to deliver significant bronchodilator effects within 5 minutes after the first dose3 and provides sustained improvement in lung function over 24 hours that results in clinically meaningful improvements in patients’ quality of life.8
Please click on the link for ‘Notes to Editors’ and ‘References’: http://bit.ly/17pNWPQ
* Striverdi® (olodaterol) Respimat® is approved for use in COPD in the UK, Canada, Denmark, Iceland and Russia. Approval and regulatory reviews by health authorities in the US and other countries worldwide are pending.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20131029006025/en/
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Linda Calandra, + 49 151 15 02 11 48
Fax: +49 6132 – 77 6601
press@boehringer-ingelheim.com
www.boehringer-ingelheim.com
Permalink: http://www.me-newswire.net/news/9012/en
World's Smallest NIBP Modules for EMS Transport Monitors from SunTech Medical
U.S. Military approved Advantage™ modules capable of remote ischemic conditioning
MORRISVILLE, N.C. - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE)-- SunTech Medical Advantage™ OEM non-invasive blood pressure (NIBP) modules provide reliable blood pressure measurement for adverse conditions during emergency medical service (EMS) transport. The product line includes the world’s smallest NIBP module, allowing medical device manufacturers to reduce the size and weight of transport monitors and defibrillators to enhance portability.
SunTech Medical Advantage OEM NIBP technologies were developed exclusively for the emergency transport market. The modules offer specific features such as ECG-gating to obtain reliable BP measurements during intense motion in ambulances, medevac helicopters and other EMS and military vehicles. Advantage modules can also support remote ischemic conditioning (RIC), which has been shown to reduce cardiac tissue damage by as much as 30 percent during a cardiac event. SunTech has further developed an innovative deflation technology that shortens measurement time and allows the monitor to meet more stringent water ingress regulations, as well as minimize product size to levels not possible with competing technologies.
Several military transport monitors using SunTech’s proprietary Transport Motion Technology have been approved by the U.S. Army Airworthiness and U.S. Air Force stringent Safe-to-Fly certification programs for reliable performance and durability in fixed and rotary wing aircraft. Advantage OEM modules are also in monitors that have undergone the RTCA DO-160 environmental conditions and test procedures for ruggedness in airborne equipment.
SunTech Medical has been a supplier of non-invasive blood pressure monitoring technology to the EMS transport industry for over 13 years. By developing blood pressure measurement technologies that focus specifically on handling transport motion and critical patients, the company’s blood pressure technology has been designed into more transport monitors than any other manufacturer.
For more information on SunTech Medical’s full line of clinical-grade non-invasive blood pressure products and technologies, call 1.800.421.8626 or visit www.suntechmed.com.
SunTech Medical, a Halma company, has been the preeminent supplier of clinical grade blood pressure monitoring products and technologies for more than 25 years. Over 75 companies trust SunTech Medical's OEM non-invasive blood pressure solutions for their patient monitoring needs.
Contacts
Halma Holdings Inc.
Rob Dietrich, +1 513-898-8007
Senior PR Specialist
Permalink: http://me-newswire.net/news/8925/en
MORRISVILLE, N.C. - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE)-- SunTech Medical Advantage™ OEM non-invasive blood pressure (NIBP) modules provide reliable blood pressure measurement for adverse conditions during emergency medical service (EMS) transport. The product line includes the world’s smallest NIBP module, allowing medical device manufacturers to reduce the size and weight of transport monitors and defibrillators to enhance portability.
SunTech Medical Advantage OEM NIBP technologies were developed exclusively for the emergency transport market. The modules offer specific features such as ECG-gating to obtain reliable BP measurements during intense motion in ambulances, medevac helicopters and other EMS and military vehicles. Advantage modules can also support remote ischemic conditioning (RIC), which has been shown to reduce cardiac tissue damage by as much as 30 percent during a cardiac event. SunTech has further developed an innovative deflation technology that shortens measurement time and allows the monitor to meet more stringent water ingress regulations, as well as minimize product size to levels not possible with competing technologies.
Several military transport monitors using SunTech’s proprietary Transport Motion Technology have been approved by the U.S. Army Airworthiness and U.S. Air Force stringent Safe-to-Fly certification programs for reliable performance and durability in fixed and rotary wing aircraft. Advantage OEM modules are also in monitors that have undergone the RTCA DO-160 environmental conditions and test procedures for ruggedness in airborne equipment.
SunTech Medical has been a supplier of non-invasive blood pressure monitoring technology to the EMS transport industry for over 13 years. By developing blood pressure measurement technologies that focus specifically on handling transport motion and critical patients, the company’s blood pressure technology has been designed into more transport monitors than any other manufacturer.
For more information on SunTech Medical’s full line of clinical-grade non-invasive blood pressure products and technologies, call 1.800.421.8626 or visit www.suntechmed.com.
SunTech Medical, a Halma company, has been the preeminent supplier of clinical grade blood pressure monitoring products and technologies for more than 25 years. Over 75 companies trust SunTech Medical's OEM non-invasive blood pressure solutions for their patient monitoring needs.
Contacts
Halma Holdings Inc.
Rob Dietrich, +1 513-898-8007
Senior PR Specialist
Permalink: http://me-newswire.net/news/8925/en
Osaka Gas Chemicals Agrees to Acquire Jacobi Carbons
ME Newswire / Businesswire
Accretive transaction to accelerate growth, expand geographical
reach and enhance R&D capabilities in fast growing activated carbon
segment
OSAKA, Japan - Tuesday, October 29th 2013
Osaka Gas Chemicals Co., Ltd. (“Osaka Gas Chemicals”), a wholly
owned subsidiary of Osaka Gas Co., Ltd (TOKYO:9532)(“Osaka Gas”),
today announced it has entered into an agreement with AddSorb
Holding AB to acquire all the shares of Jacobi Carbons AB
(“Jacobi”), the world’s largest manufacturer and distributor of
coconut shell activated carbon headquartered in Kalmar, Sweden, for
an enterprise value of US$ 400 million. The transaction is expected
to close in January 2014.
Osaka Gas Chemicals has a leading position in the activated carbon
market in Japan through its subsidiary Japan EnviroChemicals, Ltd
(“JEC”), who manufactures and distributes high-value-added
activated carbons made from coconut shells and wood sawdust. Jacobi
is the largest leading global coconut shell activated carbon
manufacturer with a comprehensive and diverse product portfolio
catering to a global blue-chip customer base across an array of
end-market applications. The acquisition will reinforce both
companies’ existing strengths in the activated carbon industry and
create a global leader across key end-market applications,
delivering significant additional value for customers.
Activated carbons are used in an increasing number of purification
processes including, among others, drinking and process water
filtration, air and gas purification, recovery of precious metals
and purification of a wide range of food products. The market for
activated carbons is expected to grow significantly due to more
stringent global regulations of water and air pollution in
developed countries and the improvement of living standards in
emerging countries. In line with Osaka Gas’ growth ambitions
outlined in ‘Field of Dreams 2020’, the development of environment
and non-energy related businesses, including the expansion of the
materials solutions business, are key areas of focus. As a result
of the acquisition, Osaka Gas Chemicals will become the third
largest manufacturer of activated carbons globally and the largest
manufacturer of high value-added activated carbon made from coconut
shells.
“Jacobi’s strong management team, led by CEO Anders Skeini, and
high level of responsiveness to customer demands have been
instrumental in transforming the business into a leading global
player that consistently outpaces activated carbon market growth”,
said Masataka Fujiwara, President of Osaka Gas Chemicals, “the
acquisition of Jacobi is directly aligned with our strategic
ambitions and enhances our existing capabilities in the attractive
activated carbon market segment”.
“The combination of Jacobi and Osaka Gas Chemicals will greatly
benefit our global customer base through an expanded product
offering, enhanced R&D capabilities and additional end-market
applications”, said Anders Skeini, CEO of Jacobi, “I look forward
to Jacobi’s next chapter of development in cooperation with Osaka
Gas Chemicals”.
Nomura International Plc acted as financial advisor to AddSorb
Holding AB and SMBC Nikko Securities, Inc. acted as financial
advisor to Osaka Gas Chemicals.
About Osaka Gas Chemicals
Incorporated in Japan in 1949, Osaka Gas Chemicals is engaged in
the manufacturing and distribution of fine materials, carbon fiber,
activated carbon fiber and adsorbents. It has made progress in
technical developments for the intensive use of coal tar developed
as a by-product of the utility gas production process by Osaka Gas.
The company employs approximately 250 people, and together with JEC
and the other 9 subsidiaries, comprises Osaka Gas Chemicals Group.
About Japan EnviroChemicals Ltd.
Incorporated in Japan in 2003, JEC is engaged in the manufacturing
and distribution of activated carbon, wood and industrial
preservatives. The company has a leading market position in
activated carbons in Japan, with its array of coconut shell and
wood sawdust activated carbon products. JEC employs approximately
110 people and has manufacturing operations in Japan, Philippines
and Malaysia.
About Osaka Gas
Incorporated in Japan in 1897, Osaka Gas (TOKYO:9532) is a leading
energy supplier with its core natural gas supply business serving 7
million customers in Japan’s Kansai region. With its portfolio of
diversified energy businesses, Osaka Gas is developing into a
multi-energy services provider of natural gas, electricity, LPG,
district heating/cooling, and other services. Through its affiliate
enterprises, the Osaka Gas Group is also active in various non-
energy business fields.
About AddSorb Holding AB
Incorporated in Sweden, AddSorb Holding AB is the holding company
of Jacobi.
About Jacobi
Incorporated in Sweden in 1916, Jacobi is the largest global
coconut shell activated carbon manufacturer with a comprehensive
and diverse product portfolio. The company, which employs
approximately 1,200 people globally, together with its
subsidiaries, has manufacturing operations in China, France,
Germany, India, Italy, Philippines, Sri Lanka, UK, US and Vietnam
and reactivation plants in France and Germany. Jacobi’s activated
carbon products are sold to its blue-chip customer base in over 100
countries through wholly owned subsidiaries in 19 countries across
the globe.
Contacts
Osaka Gas Chemicals Co., Ltd.
Shinji Sannoe, +81 (0)6-4393-0195
Team Manager
Management Planning Team, Planning Department
s-sannoe@ogc.co.jp
Permalink: http://www.me-newswire.net/news/9002/en
Accretive transaction to accelerate growth, expand geographical
reach and enhance R&D capabilities in fast growing activated carbon
segment
OSAKA, Japan - Tuesday, October 29th 2013
Osaka Gas Chemicals Co., Ltd. (“Osaka Gas Chemicals”), a wholly
owned subsidiary of Osaka Gas Co., Ltd (TOKYO:9532)(“Osaka Gas”),
today announced it has entered into an agreement with AddSorb
Holding AB to acquire all the shares of Jacobi Carbons AB
(“Jacobi”), the world’s largest manufacturer and distributor of
coconut shell activated carbon headquartered in Kalmar, Sweden, for
an enterprise value of US$ 400 million. The transaction is expected
to close in January 2014.
Osaka Gas Chemicals has a leading position in the activated carbon
market in Japan through its subsidiary Japan EnviroChemicals, Ltd
(“JEC”), who manufactures and distributes high-value-added
activated carbons made from coconut shells and wood sawdust. Jacobi
is the largest leading global coconut shell activated carbon
manufacturer with a comprehensive and diverse product portfolio
catering to a global blue-chip customer base across an array of
end-market applications. The acquisition will reinforce both
companies’ existing strengths in the activated carbon industry and
create a global leader across key end-market applications,
delivering significant additional value for customers.
Activated carbons are used in an increasing number of purification
processes including, among others, drinking and process water
filtration, air and gas purification, recovery of precious metals
and purification of a wide range of food products. The market for
activated carbons is expected to grow significantly due to more
stringent global regulations of water and air pollution in
developed countries and the improvement of living standards in
emerging countries. In line with Osaka Gas’ growth ambitions
outlined in ‘Field of Dreams 2020’, the development of environment
and non-energy related businesses, including the expansion of the
materials solutions business, are key areas of focus. As a result
of the acquisition, Osaka Gas Chemicals will become the third
largest manufacturer of activated carbons globally and the largest
manufacturer of high value-added activated carbon made from coconut
shells.
“Jacobi’s strong management team, led by CEO Anders Skeini, and
high level of responsiveness to customer demands have been
instrumental in transforming the business into a leading global
player that consistently outpaces activated carbon market growth”,
said Masataka Fujiwara, President of Osaka Gas Chemicals, “the
acquisition of Jacobi is directly aligned with our strategic
ambitions and enhances our existing capabilities in the attractive
activated carbon market segment”.
“The combination of Jacobi and Osaka Gas Chemicals will greatly
benefit our global customer base through an expanded product
offering, enhanced R&D capabilities and additional end-market
applications”, said Anders Skeini, CEO of Jacobi, “I look forward
to Jacobi’s next chapter of development in cooperation with Osaka
Gas Chemicals”.
Nomura International Plc acted as financial advisor to AddSorb
Holding AB and SMBC Nikko Securities, Inc. acted as financial
advisor to Osaka Gas Chemicals.
About Osaka Gas Chemicals
Incorporated in Japan in 1949, Osaka Gas Chemicals is engaged in
the manufacturing and distribution of fine materials, carbon fiber,
activated carbon fiber and adsorbents. It has made progress in
technical developments for the intensive use of coal tar developed
as a by-product of the utility gas production process by Osaka Gas.
The company employs approximately 250 people, and together with JEC
and the other 9 subsidiaries, comprises Osaka Gas Chemicals Group.
About Japan EnviroChemicals Ltd.
Incorporated in Japan in 2003, JEC is engaged in the manufacturing
and distribution of activated carbon, wood and industrial
preservatives. The company has a leading market position in
activated carbons in Japan, with its array of coconut shell and
wood sawdust activated carbon products. JEC employs approximately
110 people and has manufacturing operations in Japan, Philippines
and Malaysia.
About Osaka Gas
Incorporated in Japan in 1897, Osaka Gas (TOKYO:9532) is a leading
energy supplier with its core natural gas supply business serving 7
million customers in Japan’s Kansai region. With its portfolio of
diversified energy businesses, Osaka Gas is developing into a
multi-energy services provider of natural gas, electricity, LPG,
district heating/cooling, and other services. Through its affiliate
enterprises, the Osaka Gas Group is also active in various non-
energy business fields.
About AddSorb Holding AB
Incorporated in Sweden, AddSorb Holding AB is the holding company
of Jacobi.
About Jacobi
Incorporated in Sweden in 1916, Jacobi is the largest global
coconut shell activated carbon manufacturer with a comprehensive
and diverse product portfolio. The company, which employs
approximately 1,200 people globally, together with its
subsidiaries, has manufacturing operations in China, France,
Germany, India, Italy, Philippines, Sri Lanka, UK, US and Vietnam
and reactivation plants in France and Germany. Jacobi’s activated
carbon products are sold to its blue-chip customer base in over 100
countries through wholly owned subsidiaries in 19 countries across
the globe.
Contacts
Osaka Gas Chemicals Co., Ltd.
Shinji Sannoe, +81 (0)6-4393-0195
Team Manager
Management Planning Team, Planning Department
s-sannoe@ogc.co.jp
Permalink: http://www.me-newswire.net/news/9002/en
The Digital Living Network Alliance Marks Tenth Anniversary with More Than Two Billion Certified Units Sold
Alliance Celebrates Decade of Global Standards Development and Certification for Connected Digital Living; Identifies Key Industry Challenges Ahead
PORTLAND, Ore - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) The Digital Living Network Alliance (DLNA®) is celebrating a decade of enabling consumers to connect and enjoy their music, videos and photos from any DLNA Certified® product. Hundreds of multi-industry companies from around the world have joined DLNA to support a shared vision of digital interoperability, where consumers can confidently choose compatible products and content sources from a range of service providers and manufacturers, today as well as in the future.
“DLNA is widely recognized as the standard for interoperability between networked home and mobile entertainment devices,” noted Nidhish Parikh, chairman and president of DLNA. “Alliance guidelines have been adopted by both the International Electrotechnical Commission (IEC) and the U.S. Federal Communications Commission (FCC) as standards for connectivity. We are well positioned to address upcoming industry challenges as consumers adopt new content storage and sharing habits that make interoperability across a wide range of devices, applications and services even more important.”
Growth of DLNA Certified® Products
New research from industry analyst firm Parks Associates highlights DLNA’s deep reach into consumers’ digital lifestyles. With two billion DLNA Certified® products already purchased by consumers, the firm projects a total of three billion products will be sold globally by 2014 with a further increase to five billion by 2016.
“DLNA continues to be an important industry standard for the connected home, and new additions to the guidelines are likely to increase DLNA’s influence in the future,” said Brett Sappington, director of research at Parks Associates. “Sales of DLNA Certified® products will see significant growth in upcoming years, exceeding the rate of growth of non-certified products in several categories.”
Additional Parks Associates’ findings in each of the fastest growing DLNA product categories include:
The projected compounded annual growth (CAGR) of global DLNA Certified® device shipments exceeds those of corresponding non-DLNA Certified® devices in almost all product categories. Unit volume is highest in smartphones, tablets, computers, and smart TVs.
Overall sales of DLNA Certified® devices across all categories will grow at an annual rate of 15 percent through 2018.
Driven by the increase in video consumption on mobile devices, smartphones are the highest volume global market for DLNA Certified® products, with 264 million DLNA Certified® smartphones sold during 2013.
Looking Forward to the Industry Challenges Ahead
DLNA has identified a number of key trends and industry challenges for 2014 and beyond that will require a continuing focus on specifications that meet an evolving connected lifestyle. These specifications will leverage the broadly adopted foundation DLNA has established over the past 10 years. Industry trends and challenges include:
New types of entertainment applications and services that will impact the sales, features and interoperability requirements of products including set-top boxes, gateways and televisions, as well as smartphones, computers and tablets.
The implications of the cloud for the connected lifestyle.
Emerging digital platforms including the connected car.
“DLNA continues to build on its guidelines to create greater consumer engagement across DLNA Certified® devices,” continued Parikh. “DLNA has already built the strong guidelines framework needed to address new and emerging industry trends. We will continue to advance DLNA to accommodate ongoing changes in the market. These efforts, combined with an ever-growing list of members committed to furthering the Alliance’s mission, are laying the groundwork for another successful decade of innovation and interoperability.”
To access the complete Parks Associates "DLNA Market Overview 2013" report, please visit: http://www.dlna.org/dlna-for-industry/newsroom/parks-associates-report-2013.
About DLNA
The Digital Living Network Alliance (DLNA) is a technology standards organization driven to build industry consensus to advance the interoperability of products in consumers’ connected homes. Founded in 2003 with a current membership of more than 250 companies, this unique multi-industry collaboration continues to implement an innovative set of guidelines utilized by service providers, electronics manufacturers, and software developers to provide consistent performance in a connected home environment. Consumers can share and enjoy personal and premium content, regardless of manufacturer, on a wide variety of products including mobile devices, PCs, set top boxes, AV receivers, game consoles, TVs and more. DLNA has also created a robust certification program which tests and verifies the interoperability of products built to its standards, ensuring consumers that devices branded with the DLNA Certified® mark will successfully connect and exchange content. Additional information about the Alliance is available at www.dlna.org. Find DLNA on Facebook at facebook.com/dlnacertified or on Twitter @DLNA.
DLNA's leading member companies include ACCESS, ARRIS, AT&T, AwoX, Broadcom, CableLabs, Cisco, Comcast, DIRECTV, Dolby Laboratories, DTS, Google, Huawei, Intel, LG, Microsoft, Nokia, Panasonic, Qualcomm, Samsung, Sony, Technicolor, Time Warner Cable and Verizon.
Contacts
Digital Living Network Alliance
Katie Gengler, 503-908-1121
Katie@global-dlna.org
Permalink: http://www.me-newswire.net/news/8964/en
PORTLAND, Ore - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) The Digital Living Network Alliance (DLNA®) is celebrating a decade of enabling consumers to connect and enjoy their music, videos and photos from any DLNA Certified® product. Hundreds of multi-industry companies from around the world have joined DLNA to support a shared vision of digital interoperability, where consumers can confidently choose compatible products and content sources from a range of service providers and manufacturers, today as well as in the future.
“DLNA is widely recognized as the standard for interoperability between networked home and mobile entertainment devices,” noted Nidhish Parikh, chairman and president of DLNA. “Alliance guidelines have been adopted by both the International Electrotechnical Commission (IEC) and the U.S. Federal Communications Commission (FCC) as standards for connectivity. We are well positioned to address upcoming industry challenges as consumers adopt new content storage and sharing habits that make interoperability across a wide range of devices, applications and services even more important.”
Growth of DLNA Certified® Products
New research from industry analyst firm Parks Associates highlights DLNA’s deep reach into consumers’ digital lifestyles. With two billion DLNA Certified® products already purchased by consumers, the firm projects a total of three billion products will be sold globally by 2014 with a further increase to five billion by 2016.
“DLNA continues to be an important industry standard for the connected home, and new additions to the guidelines are likely to increase DLNA’s influence in the future,” said Brett Sappington, director of research at Parks Associates. “Sales of DLNA Certified® products will see significant growth in upcoming years, exceeding the rate of growth of non-certified products in several categories.”
Additional Parks Associates’ findings in each of the fastest growing DLNA product categories include:
The projected compounded annual growth (CAGR) of global DLNA Certified® device shipments exceeds those of corresponding non-DLNA Certified® devices in almost all product categories. Unit volume is highest in smartphones, tablets, computers, and smart TVs.
Overall sales of DLNA Certified® devices across all categories will grow at an annual rate of 15 percent through 2018.
Driven by the increase in video consumption on mobile devices, smartphones are the highest volume global market for DLNA Certified® products, with 264 million DLNA Certified® smartphones sold during 2013.
Looking Forward to the Industry Challenges Ahead
DLNA has identified a number of key trends and industry challenges for 2014 and beyond that will require a continuing focus on specifications that meet an evolving connected lifestyle. These specifications will leverage the broadly adopted foundation DLNA has established over the past 10 years. Industry trends and challenges include:
New types of entertainment applications and services that will impact the sales, features and interoperability requirements of products including set-top boxes, gateways and televisions, as well as smartphones, computers and tablets.
The implications of the cloud for the connected lifestyle.
Emerging digital platforms including the connected car.
“DLNA continues to build on its guidelines to create greater consumer engagement across DLNA Certified® devices,” continued Parikh. “DLNA has already built the strong guidelines framework needed to address new and emerging industry trends. We will continue to advance DLNA to accommodate ongoing changes in the market. These efforts, combined with an ever-growing list of members committed to furthering the Alliance’s mission, are laying the groundwork for another successful decade of innovation and interoperability.”
To access the complete Parks Associates "DLNA Market Overview 2013" report, please visit: http://www.dlna.org/dlna-for-industry/newsroom/parks-associates-report-2013.
About DLNA
The Digital Living Network Alliance (DLNA) is a technology standards organization driven to build industry consensus to advance the interoperability of products in consumers’ connected homes. Founded in 2003 with a current membership of more than 250 companies, this unique multi-industry collaboration continues to implement an innovative set of guidelines utilized by service providers, electronics manufacturers, and software developers to provide consistent performance in a connected home environment. Consumers can share and enjoy personal and premium content, regardless of manufacturer, on a wide variety of products including mobile devices, PCs, set top boxes, AV receivers, game consoles, TVs and more. DLNA has also created a robust certification program which tests and verifies the interoperability of products built to its standards, ensuring consumers that devices branded with the DLNA Certified® mark will successfully connect and exchange content. Additional information about the Alliance is available at www.dlna.org. Find DLNA on Facebook at facebook.com/dlnacertified or on Twitter @DLNA.
DLNA's leading member companies include ACCESS, ARRIS, AT&T, AwoX, Broadcom, CableLabs, Cisco, Comcast, DIRECTV, Dolby Laboratories, DTS, Google, Huawei, Intel, LG, Microsoft, Nokia, Panasonic, Qualcomm, Samsung, Sony, Technicolor, Time Warner Cable and Verizon.
Contacts
Digital Living Network Alliance
Katie Gengler, 503-908-1121
Katie@global-dlna.org
Permalink: http://www.me-newswire.net/news/8964/en
Tuesday, October 29, 2013
EY: Cyber-Crime is greatest global threat to organizations' survival today
LONDON - Tuesday, October 29th 2013 [ME NewsWire]
Information security function fully meets needs in only 17% of organizations
Ninety-three per cent of companies maintained or increased security budget over last 12 months – yet budget constraints still biggest obstacle to delivering value
Organizations must be forward-looking and prepare for emerging technologies
Talent shortage hindering fight against cyber-attacks – especially in Europe
(BUSINESS WIRE) With information security functions not fully meeting the needs in 83% of organizations, 93% of companies globally are maintaining or increasing their investment in cyber-security to combat the ever increasing threat from cyber-attacks, according to a new survey released by EY today.
Under cyber-attack, EY's 16th annual Global Information Security Survey 2013 tracks the level of awareness and action by companies in response to cyber threats and canvases the opinion of over 1,900 senior executives globally. This year’s results show that as companies continue to invest heavily to protect themselves against cyber-attacks, the number of security breaches is on the rise and it is no longer of question of if, but when, a company will be the target of an attack.
Thirty-one percent of respondents report the number of security incidents within their organization has increased by at least 5% over the last 12 months. Many have realized the extent and depth of the threat posed to them; resulting in information security now being ‘owned’ at the highest level within 70% of the organizations surveyed.
Paul van Kessel, EY Global Risk Leader comments “This year’s survey shows that organizations are moving in the right direction, but more still needs to be done – urgently. There are promising signs that the issue is now gaining traction at the highest levels. In 2012, none of the information security professionals surveyed reported to senior executives – in 2013 this jumped to 35%.”
Ken Allan, EY Global Information Security Leader adds: “Cyber-crime is the greatest threat for organizations’ survival today. While budget allocations toward security innovation are inching their way up, enabling organizations to channel more resources toward innovating solutions that can protect them against the great unknown – the future – many information security professionals continue to feel that their budgets are insufficient to address mounting cyber risks.”
Information security departments are still feeling the pinch
Despite half of the respondents planning to increase their budget by 5% or more in the next 12 months, 65% cite an insufficient budget as their number one challenge to operating at the levels the business expects; and among organizations with revenues of US$10m or less this figure rises to 71%.
Of the budgets planned for the next 12 months, 14% is ear-marked for security innovation and emerging technologies. As current technologies become further entrenched in an organization’s network and culture, organizations need to be aware of how employees use the devices, both in the workplace and in their personal lives. This is especially true when it comes to social media, which respondents identified as an area where they continue to still feel unsure in their capability to address risks.
Ken explains: “Organizations need to be more forward-looking. Moreover, if organizations are putting all their energy into addressing current technology issues, how will they protect themselves against technologies that are just around the corner or are about to appear on the horizon? If organizations still don’t have a high level of confidence after four years of mobile device use in the workplace, how will they face the challenge of managing and defending against personal and hosted clouds for example?”
Information security departments struggle with a lack of skilled resources
Although information security is focusing on the right priorities, in many instances, the function doesn’t have the skilled resources or executive awareness and support needed to address them.
In particular, the gap is widening between supply and demand, creating a sellers’ market, with 50% of respondents citing a lack of skilled resources as a barrier to value creation. Similarly, where only 20% of previous survey participants indicated a lack of executive awareness or support, 31% now cite it as an issue.
Ken comments: “A lack of skilled talent is a global issue. It is particularly acute in Europe, where governments and companies are fiercely competing to recruit the brightest talent to their teams from a very small pool. As a result, while organizations feel they are addressing the right priorities, many indicate that they do not have the skilled resources to support their needs.”
Looking ahead Paul concludes: “Organizations must undertake more proactive thinking, with tone-from-the-top support. Greater emphasis on improving employee awareness, increasing budgets and devoting more resources to innovating security solutions is needed. The pace of technology evolution will only accelerate – as will the cyber risks and by not considering risks until they arise gives cyber attackers the advantage, jeopardizing an organization’s survival.”
For further information and to download the 2013 report, visit www.ey.com/GISS
About EY
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com.
This news release has been issued by EYGM Limited, a member of the global EY organization that also does not provide any services to clients.
Contacts
EY Global Media Relations
Ann Burton
+44 (0)20 7980 0552
Ann.Burton@uk.ey.com
Information security function fully meets needs in only 17% of organizations
Ninety-three per cent of companies maintained or increased security budget over last 12 months – yet budget constraints still biggest obstacle to delivering value
Organizations must be forward-looking and prepare for emerging technologies
Talent shortage hindering fight against cyber-attacks – especially in Europe
(BUSINESS WIRE) With information security functions not fully meeting the needs in 83% of organizations, 93% of companies globally are maintaining or increasing their investment in cyber-security to combat the ever increasing threat from cyber-attacks, according to a new survey released by EY today.
Under cyber-attack, EY's 16th annual Global Information Security Survey 2013 tracks the level of awareness and action by companies in response to cyber threats and canvases the opinion of over 1,900 senior executives globally. This year’s results show that as companies continue to invest heavily to protect themselves against cyber-attacks, the number of security breaches is on the rise and it is no longer of question of if, but when, a company will be the target of an attack.
Thirty-one percent of respondents report the number of security incidents within their organization has increased by at least 5% over the last 12 months. Many have realized the extent and depth of the threat posed to them; resulting in information security now being ‘owned’ at the highest level within 70% of the organizations surveyed.
Paul van Kessel, EY Global Risk Leader comments “This year’s survey shows that organizations are moving in the right direction, but more still needs to be done – urgently. There are promising signs that the issue is now gaining traction at the highest levels. In 2012, none of the information security professionals surveyed reported to senior executives – in 2013 this jumped to 35%.”
Ken Allan, EY Global Information Security Leader adds: “Cyber-crime is the greatest threat for organizations’ survival today. While budget allocations toward security innovation are inching their way up, enabling organizations to channel more resources toward innovating solutions that can protect them against the great unknown – the future – many information security professionals continue to feel that their budgets are insufficient to address mounting cyber risks.”
Information security departments are still feeling the pinch
Despite half of the respondents planning to increase their budget by 5% or more in the next 12 months, 65% cite an insufficient budget as their number one challenge to operating at the levels the business expects; and among organizations with revenues of US$10m or less this figure rises to 71%.
Of the budgets planned for the next 12 months, 14% is ear-marked for security innovation and emerging technologies. As current technologies become further entrenched in an organization’s network and culture, organizations need to be aware of how employees use the devices, both in the workplace and in their personal lives. This is especially true when it comes to social media, which respondents identified as an area where they continue to still feel unsure in their capability to address risks.
Ken explains: “Organizations need to be more forward-looking. Moreover, if organizations are putting all their energy into addressing current technology issues, how will they protect themselves against technologies that are just around the corner or are about to appear on the horizon? If organizations still don’t have a high level of confidence after four years of mobile device use in the workplace, how will they face the challenge of managing and defending against personal and hosted clouds for example?”
Information security departments struggle with a lack of skilled resources
Although information security is focusing on the right priorities, in many instances, the function doesn’t have the skilled resources or executive awareness and support needed to address them.
In particular, the gap is widening between supply and demand, creating a sellers’ market, with 50% of respondents citing a lack of skilled resources as a barrier to value creation. Similarly, where only 20% of previous survey participants indicated a lack of executive awareness or support, 31% now cite it as an issue.
Ken comments: “A lack of skilled talent is a global issue. It is particularly acute in Europe, where governments and companies are fiercely competing to recruit the brightest talent to their teams from a very small pool. As a result, while organizations feel they are addressing the right priorities, many indicate that they do not have the skilled resources to support their needs.”
Looking ahead Paul concludes: “Organizations must undertake more proactive thinking, with tone-from-the-top support. Greater emphasis on improving employee awareness, increasing budgets and devoting more resources to innovating security solutions is needed. The pace of technology evolution will only accelerate – as will the cyber risks and by not considering risks until they arise gives cyber attackers the advantage, jeopardizing an organization’s survival.”
For further information and to download the 2013 report, visit www.ey.com/GISS
About EY
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.
EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com.
This news release has been issued by EYGM Limited, a member of the global EY organization that also does not provide any services to clients.
Contacts
EY Global Media Relations
Ann Burton
+44 (0)20 7980 0552
Ann.Burton@uk.ey.com
Procter & Gamble Brands Unite to Kick Off Sochi 2014 Olympic Winter Games ‘Thank You Mom’ Campaign by Launching a Series of 28 Raising an Olympian Films
Raising an Olympian series pays tribute to moms by showcasing the journey of world-class athletes as seen through eyes of their moms
CINCINNATI - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) Procter & Gamble (NYSE: PG), a Worldwide Olympic Partner, kicked off the company’s Thank You Mom campaign today with the Raising an Olympian series featuring Olay® athlete Lindsey Vonn (United States), Gillette® athletes Felix Neureuther (Germany) and Sven Kramer (Netherlands) and Pantene® athlete Elena Ilinykh (Russia).
The launch of the Thank You Mom campaign marks 100 days to go until the start of the Sochi 2014 Olympic Winter Games and is supported by more than fifteen P&G brands around the globe such as Pampers®, Head & Shoulders® and COVERGIRL®.
“P&G brands look at Olympic sponsorship through a special lens,” said Marc Pritchard P&G Global Brand Building Officer. “Our brands don’t just live at the finish line; they’re about the everyday journey athletes take to get to the Games, a journey they started in childhood with their moms. That’s why if a P&G brand sponsors an athlete, we also celebrate the mom who helped get them there.”
The P&G Sochi 2014 campaign will come to life through P&G’s iconic brands and their inspiring campaigns:
P&G Beauty will inspire women to ‘Look Winter Wonderful’ this season, and the Olay campaign in particular will feature LINDSEY VONN (U.S. Olympic Gold Medalist, Alpine Skiing)
Gillette is encouraging men everywhere to ‘Reveal their Inner Steel’ featuring ALEXANDER OVECHKIN (Russian Olympian, Ice Hockey), as well as SVEN KRAMER (Dutch Olympic Gold Medalist, Speed Skating)
Pantene and ELENA ILINYKH (Russian Olympic Hopeful, Figure Skating), are proving that hair can pass the winter torture test to ‘Win Over Winter and Shine!’
Head & Shoulders is washing out flakes, washing in Inner Confidence with EVGENI MALKIN (Russian Olympian, Ice Hockey)
Bounty® recognizes that if you’re raising an aspiring athlete, then it helps to be uninhibited by messes with the ‘Let the Spills Begin’ campaign featuring JULIE CHU (U.S. Olympic Medalist and National Team Forward, Women's Ice Hockey)
Blend-a-Med® and Crest® campaigns, featuring ALENA LEONOVA (Russian Olympic Hopeful, Figure Skating) and EVAN LYSACEK (U.S. Olympic Gold Medalist, Figure Skating) highlight that when you want to get noticed you need to “Be Prepared for Your Spotlight Moment”.
“I would never be the athlete I am today without my mom,” said Dutch speed skating Gold Medalist Sven Kramer. “So I’m proud to be a Gillette athlete not just because Gillette stands for the highest standard of performance, but because of the way they’ve treated my mom.”
U.S. Olympic Gold Medalist, Lindsey Vonn also comments, “I am so excited to be part of P&G’s Thank You Mom program and be in the company of some of the greatest athletes in the world, sponsored by P&G and some of the greatest brands in the world. In our training and competitions, we combat all the elements. As a skier, my skin undergoes the most extreme winter conditions. That’s why I trust Olay to keep my skin as healthy as possible.”
Through the Raising an Olympian series P&G is paying homage to moms of athletes from across the globe, bringing to life the daily lessons all moms teach. From their kid’s first steps to their first failures, the series highlights the unconditional love moms give their kids no matter what. Additional athletes featured in the Raising an Olympian series include Tessa Virtue and Scott Moir (Canadian Olympic Gold Medalists, Figure Skating) sponsored by P&G Beauty products like Pantene and Olay, USA’s Julie Chu who is sponsored by Bounty and Ekaterina Bobrova (Russian Ice Dancer) sponsored by Venus®.
“From Pampers to Crest and Ariel, our brands exist to serve moms and their families,” said Pritchard. “So when we look at the determination, commitment and grit that gets an athlete to the Olympic Games, we see the mom who helped teach those things. That’s why our brands are dedicated to not only our athletes, but also supporting their moms.”
The first half of the Raising an Olympian films can be viewed at: P&G Raising an Olympian
As part of P&G’s dedication to bringing the best to moms around the world, the Thank You Mom campaign will come to life through a variety of media channels and in store. Two million retailers throughout the world will feature P&G Olympic Games themed athlete packaging, end caps and displays.
To view photos, videos and additional information related to the P&G Thank You Mom campaign, visit www.image.net/pgolympicgames.
About P&G
P&G serves approximately 4.8 billion people around the world with its brands. The Company has one of the strongest portfolios of trusted, quality, leadership brands, including Ace®, Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Duracell®, Fairy®, Febreze®, Fusion®, Gain®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Oral-B®, Pampers®, Pantene®, Prestobarba®, SK-II®, Tide®, Vicks®, Wella®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Contacts
P&G
Jeannie Tharrington, +1-513-698-4607
tharrington.jm@pg.com
MMK
Tamara Jacobs, +1-770-971-0677
tamara.jacobs@ketchum.com
Permalink: http://www.me-newswire.net/news/9001/en
CINCINNATI - Tuesday, October 29th 2013 [ME NewsWire]
(BUSINESS WIRE) Procter & Gamble (NYSE: PG), a Worldwide Olympic Partner, kicked off the company’s Thank You Mom campaign today with the Raising an Olympian series featuring Olay® athlete Lindsey Vonn (United States), Gillette® athletes Felix Neureuther (Germany) and Sven Kramer (Netherlands) and Pantene® athlete Elena Ilinykh (Russia).
The launch of the Thank You Mom campaign marks 100 days to go until the start of the Sochi 2014 Olympic Winter Games and is supported by more than fifteen P&G brands around the globe such as Pampers®, Head & Shoulders® and COVERGIRL®.
“P&G brands look at Olympic sponsorship through a special lens,” said Marc Pritchard P&G Global Brand Building Officer. “Our brands don’t just live at the finish line; they’re about the everyday journey athletes take to get to the Games, a journey they started in childhood with their moms. That’s why if a P&G brand sponsors an athlete, we also celebrate the mom who helped get them there.”
The P&G Sochi 2014 campaign will come to life through P&G’s iconic brands and their inspiring campaigns:
P&G Beauty will inspire women to ‘Look Winter Wonderful’ this season, and the Olay campaign in particular will feature LINDSEY VONN (U.S. Olympic Gold Medalist, Alpine Skiing)
Gillette is encouraging men everywhere to ‘Reveal their Inner Steel’ featuring ALEXANDER OVECHKIN (Russian Olympian, Ice Hockey), as well as SVEN KRAMER (Dutch Olympic Gold Medalist, Speed Skating)
Pantene and ELENA ILINYKH (Russian Olympic Hopeful, Figure Skating), are proving that hair can pass the winter torture test to ‘Win Over Winter and Shine!’
Head & Shoulders is washing out flakes, washing in Inner Confidence with EVGENI MALKIN (Russian Olympian, Ice Hockey)
Bounty® recognizes that if you’re raising an aspiring athlete, then it helps to be uninhibited by messes with the ‘Let the Spills Begin’ campaign featuring JULIE CHU (U.S. Olympic Medalist and National Team Forward, Women's Ice Hockey)
Blend-a-Med® and Crest® campaigns, featuring ALENA LEONOVA (Russian Olympic Hopeful, Figure Skating) and EVAN LYSACEK (U.S. Olympic Gold Medalist, Figure Skating) highlight that when you want to get noticed you need to “Be Prepared for Your Spotlight Moment”.
“I would never be the athlete I am today without my mom,” said Dutch speed skating Gold Medalist Sven Kramer. “So I’m proud to be a Gillette athlete not just because Gillette stands for the highest standard of performance, but because of the way they’ve treated my mom.”
U.S. Olympic Gold Medalist, Lindsey Vonn also comments, “I am so excited to be part of P&G’s Thank You Mom program and be in the company of some of the greatest athletes in the world, sponsored by P&G and some of the greatest brands in the world. In our training and competitions, we combat all the elements. As a skier, my skin undergoes the most extreme winter conditions. That’s why I trust Olay to keep my skin as healthy as possible.”
Through the Raising an Olympian series P&G is paying homage to moms of athletes from across the globe, bringing to life the daily lessons all moms teach. From their kid’s first steps to their first failures, the series highlights the unconditional love moms give their kids no matter what. Additional athletes featured in the Raising an Olympian series include Tessa Virtue and Scott Moir (Canadian Olympic Gold Medalists, Figure Skating) sponsored by P&G Beauty products like Pantene and Olay, USA’s Julie Chu who is sponsored by Bounty and Ekaterina Bobrova (Russian Ice Dancer) sponsored by Venus®.
“From Pampers to Crest and Ariel, our brands exist to serve moms and their families,” said Pritchard. “So when we look at the determination, commitment and grit that gets an athlete to the Olympic Games, we see the mom who helped teach those things. That’s why our brands are dedicated to not only our athletes, but also supporting their moms.”
The first half of the Raising an Olympian films can be viewed at: P&G Raising an Olympian
As part of P&G’s dedication to bringing the best to moms around the world, the Thank You Mom campaign will come to life through a variety of media channels and in store. Two million retailers throughout the world will feature P&G Olympic Games themed athlete packaging, end caps and displays.
To view photos, videos and additional information related to the P&G Thank You Mom campaign, visit www.image.net/pgolympicgames.
About P&G
P&G serves approximately 4.8 billion people around the world with its brands. The Company has one of the strongest portfolios of trusted, quality, leadership brands, including Ace®, Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Duracell®, Fairy®, Febreze®, Fusion®, Gain®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Oral-B®, Pampers®, Pantene®, Prestobarba®, SK-II®, Tide®, Vicks®, Wella®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Contacts
P&G
Jeannie Tharrington, +1-513-698-4607
tharrington.jm@pg.com
MMK
Tamara Jacobs, +1-770-971-0677
tamara.jacobs@ketchum.com
Permalink: http://www.me-newswire.net/news/9001/en
KCI Completes Acquisition of Systagenix
Peter Huntley Appointed Senior Vice President and Leader of Systagenix
SAN ANTONIO - Monday, October 28th 2013 [ME NewsWire]
(BUSINESS WIRE)-- Kinetic Concepts, Inc. (KCI) announced today that it has completed its acquisition of Systagenix, an established provider of advanced wound care products based in the United Kingdom. The acquisition of Systagenix enhances KCI’s position as a leading provider of transformational healing solutions with a diverse product portfolio dedicated to advancing the practice of medicine and improving patient lives around the world. The purchase price was $485 million.
As previously announced, KCI, Systagenix and LifeCell Corporation now form one company, a global leader in medical technology with more than $2 billion in revenue, poised for future success as a geographically diversified company with world-class wound care and biologics franchises.
“The successful completion of the Systagenix acquisition marks an important milestone in the advancement of our long-term strategy as the global leader in transformational healing solutions,” said Joe Woody, president & CEO. “Together, KCI, Systagenix and LifeCell will deliver customer-focused innovations and realize new possibilities beyond that which we could have achieved as a stand-alone organization.”
In connection with the acquisition, KCI announced that Peter Huntley has been appointed as senior vice president and leader of Systagenix going forward, reporting to KCI President & CEO Joe Woody. Huntley has more than 15 years of experience in the healthcare industry and was most recently CEO of Corin Group plc, where he successfully returned its orthopedics business to growth. Prior to Corin, Peter was a member of the executive committee at Smith & Nephew for 10 years, holding several roles including Group Director, Strategy and Business Development and later Group Director, Indirect Markets, where he was responsible for sales and marketing of the orthopedic reconstruction, orthopedic trauma, endoscopy and wound management portfolios. Ernest Waaser, departing CEO of Systagenix, will remain with the company for the next few months to support the integration efforts.
“I am pleased to welcome Peter Huntley as the new leader of Systagenix. He has extensive global leadership experience and a long track record of commercial success in the industry, which will add tremendous value as we combine KCI, Systagenix and LifeCell into a single company,” Woody continued. “I would also like to thank Ernest Waaser for his outstanding leadership of Systagenix that has brought us to this exciting milestone. The KCI family of companies and employees wishes him the best in his future endeavors.”
“This is an incredible opportunity and I am excited to lead the Systagenix team and to continue to build on the franchise’s compelling brand and product offerings,” said Peter Huntley, senior vice president, Systagenix. “I also look forward to collaborating with my new colleagues to drive growth and customer value across the combined company.”
Goldman, Sachs & Co. (lead advisor), BofA Merrill Lynch and Morgan Stanley provided financial advice to KCI. Debt financing for the transaction was provided by BofA Merrill Lynch, Morgan Stanley and Goldman, Sachs & Co. Simpson Thacher & Bartlett LLP and Kirkland & Ellis LLP acted as legal advisors to KCI. Jones Day acted as legal advisor to Systagenix.
About KCI
KCI is a leading global medical technology company devoted to understanding, developing and commercializing innovative, high-technology transformational healing solutions for customers and patients in more than 65 countries around the world. Headquartered in San Antonio, Texas, KCI is committed to advancing the science of healing and positively impacting patient care by developing customer-driven innovations to meet the evolving needs of healthcare professionals. Proprietary KCI negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 7 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.
About LifeCell
LifeCell, based in Bridgewater, NJ, is a leader in regenerative medicine, develops and markets innovative tissue repair products for the reconstructive, orthopedic and urogynecologic biosurgery markets. LifeCell™ products include Strattice™ Reconstructive Tissue Matrix and AlloDerm® regenerative Tissue Matrix for plastic, reconstructive, and general surgical applications; Cymetra® Regenerative Tissue Matrix, a particulate form of AlloDerm® Tissue Matrix suitable for injection; Repliform® Regenerative Tissue Matrix for urogynecologic surgical procedures; Graftjacket® and Conexa™ for orthopedic surgical procedures; and the SPY® Elite System for the visualization and evaluation of tissue perfusion. Additional information about LifeCell and its products is available at www.LifeCell.com.
About Systagenix
Systagenix is a global leader in innovative wound care established in 2008 following the acquisition of Johnson & Johnson’s professional wound care business by One Equity Partners. Systagenix is 100% dedicated to wound care, developing and marketing advanced wound diagnostic and therapeutic solutions and supplying over 20 million advanced wound dressings per month globally. Systagenix’ longstanding commitment to skin and wound care began with innovative wound care treatments developed by the experienced team of R&D Scientists at the Gargrave Centre of Excellence for Wound Healing in North Yorkshire, England. With approximately 800 employees worldwide, Systagenix distributes products and services to more than 75 countries.
Contacts
For more information:
KCI Corporate Communications
Mike Barger, +1-210-255-6824
mike.barger@kci1.com
KCI Investor Relations
Nathan Speicher, +1-210-255-6027
nathan.speicher@kci1.com
Permalink: http://me-newswire.net/news/8963/en
SAN ANTONIO - Monday, October 28th 2013 [ME NewsWire]
(BUSINESS WIRE)-- Kinetic Concepts, Inc. (KCI) announced today that it has completed its acquisition of Systagenix, an established provider of advanced wound care products based in the United Kingdom. The acquisition of Systagenix enhances KCI’s position as a leading provider of transformational healing solutions with a diverse product portfolio dedicated to advancing the practice of medicine and improving patient lives around the world. The purchase price was $485 million.
As previously announced, KCI, Systagenix and LifeCell Corporation now form one company, a global leader in medical technology with more than $2 billion in revenue, poised for future success as a geographically diversified company with world-class wound care and biologics franchises.
“The successful completion of the Systagenix acquisition marks an important milestone in the advancement of our long-term strategy as the global leader in transformational healing solutions,” said Joe Woody, president & CEO. “Together, KCI, Systagenix and LifeCell will deliver customer-focused innovations and realize new possibilities beyond that which we could have achieved as a stand-alone organization.”
In connection with the acquisition, KCI announced that Peter Huntley has been appointed as senior vice president and leader of Systagenix going forward, reporting to KCI President & CEO Joe Woody. Huntley has more than 15 years of experience in the healthcare industry and was most recently CEO of Corin Group plc, where he successfully returned its orthopedics business to growth. Prior to Corin, Peter was a member of the executive committee at Smith & Nephew for 10 years, holding several roles including Group Director, Strategy and Business Development and later Group Director, Indirect Markets, where he was responsible for sales and marketing of the orthopedic reconstruction, orthopedic trauma, endoscopy and wound management portfolios. Ernest Waaser, departing CEO of Systagenix, will remain with the company for the next few months to support the integration efforts.
“I am pleased to welcome Peter Huntley as the new leader of Systagenix. He has extensive global leadership experience and a long track record of commercial success in the industry, which will add tremendous value as we combine KCI, Systagenix and LifeCell into a single company,” Woody continued. “I would also like to thank Ernest Waaser for his outstanding leadership of Systagenix that has brought us to this exciting milestone. The KCI family of companies and employees wishes him the best in his future endeavors.”
“This is an incredible opportunity and I am excited to lead the Systagenix team and to continue to build on the franchise’s compelling brand and product offerings,” said Peter Huntley, senior vice president, Systagenix. “I also look forward to collaborating with my new colleagues to drive growth and customer value across the combined company.”
Goldman, Sachs & Co. (lead advisor), BofA Merrill Lynch and Morgan Stanley provided financial advice to KCI. Debt financing for the transaction was provided by BofA Merrill Lynch, Morgan Stanley and Goldman, Sachs & Co. Simpson Thacher & Bartlett LLP and Kirkland & Ellis LLP acted as legal advisors to KCI. Jones Day acted as legal advisor to Systagenix.
About KCI
KCI is a leading global medical technology company devoted to understanding, developing and commercializing innovative, high-technology transformational healing solutions for customers and patients in more than 65 countries around the world. Headquartered in San Antonio, Texas, KCI is committed to advancing the science of healing and positively impacting patient care by developing customer-driven innovations to meet the evolving needs of healthcare professionals. Proprietary KCI negative pressure technologies have revolutionized the way in which caregivers treat a wide variety of wound types. The V.A.C.® Therapy System has been used on more than 7 million wounds worldwide. Additional information about KCI and its products is available at www.KCI1.com.
About LifeCell
LifeCell, based in Bridgewater, NJ, is a leader in regenerative medicine, develops and markets innovative tissue repair products for the reconstructive, orthopedic and urogynecologic biosurgery markets. LifeCell™ products include Strattice™ Reconstructive Tissue Matrix and AlloDerm® regenerative Tissue Matrix for plastic, reconstructive, and general surgical applications; Cymetra® Regenerative Tissue Matrix, a particulate form of AlloDerm® Tissue Matrix suitable for injection; Repliform® Regenerative Tissue Matrix for urogynecologic surgical procedures; Graftjacket® and Conexa™ for orthopedic surgical procedures; and the SPY® Elite System for the visualization and evaluation of tissue perfusion. Additional information about LifeCell and its products is available at www.LifeCell.com.
About Systagenix
Systagenix is a global leader in innovative wound care established in 2008 following the acquisition of Johnson & Johnson’s professional wound care business by One Equity Partners. Systagenix is 100% dedicated to wound care, developing and marketing advanced wound diagnostic and therapeutic solutions and supplying over 20 million advanced wound dressings per month globally. Systagenix’ longstanding commitment to skin and wound care began with innovative wound care treatments developed by the experienced team of R&D Scientists at the Gargrave Centre of Excellence for Wound Healing in North Yorkshire, England. With approximately 800 employees worldwide, Systagenix distributes products and services to more than 75 countries.
Contacts
For more information:
KCI Corporate Communications
Mike Barger, +1-210-255-6824
mike.barger@kci1.com
KCI Investor Relations
Nathan Speicher, +1-210-255-6027
nathan.speicher@kci1.com
Permalink: http://me-newswire.net/news/8963/en
Oral Apremilast Demonstrated Rapid, Clinically Significant Improvements in Oral Ulcers in Patients with Behçet’s Disease in a Phase II Trial
BOUDRY, Switzerland - Monday, October 28th 2013 [ME NewsWire]
71% of patients achieved complete response at week 12 in clearing of ulcers
Apremilast also improved quality of life measures and pain associated with active oral ulcers, the cardinal manifestation of Behçet’s disease
Limited therapies currently available in U.S. or Europe for this orphan chronic inflammatory disorder
(BUSINESS WIRE)-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today presented phase II trial (BCT-001) results of apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in patients with Behçet’s disease. The findings were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. These results have been featured as part of the official ACR press program, which highlights data considered representative of the highest quality and most meaningful research presented at the ACR annual meeting.
Behçet’s disease is a rare and chronic inflammatory disorder characterized by recurrent oral and genital ulcers, skin and eye lesions (which may cause blindness) and joint inflammation. Inflammation may also affect the brain and gastrointestinal tract.
These data, which were also presented at the European League Against Rheumatism (EULAR) annual meeting this year in June, showed that significantly more patients on apremilast achieved a complete response (were free from active oral ulcers) at week 12 compared with those on placebo (apremilast, 71%; placebo, 29%; p<0.0001). Among patients with genital ulcers at baseline (n=16), 100% of those receiving apremilast had a complete response at week 12 compared with 50% of those receiving placebo (p=0.036).
“Behçet’s disease can have a severe negative impact on patients’ quality of life, and there are limited therapies available, so there is a clear need for a new therapy to help this patient population,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey. “We are encouraged by the rapid response seen in this important phase II study and by apremilast’s potential to treat oral ulcers in this orphan disease.”
The beneficial effect of apremilast on oral ulcers reached a stable effect within two weeks and was sustained while patients remained on treatment.
At week 12, apremilast also improved several patient-reported outcome scores, including the Behçet’s disease current activity form (BDCAF), Behçet’s syndrome activity score (BSAS) and Behçet’s disease quality of life (QoL) instrument. Improvement in oral ulcer pain was also significantly higher with apremilast than with placebo (apremilast, -44.7 ± 24.30; placebo, -16.0 ± 32.54; p<0.0001).
The type and severity of adverse events (AEs) were comparable to the known apremilast safety profile. In BCT-001, treatment-emergent adverse events (TEAE), including severe and serious adverse events (SAEs) and withdrawal due to adverse events, were comparable between 30 mg twice daily (BID) and placebo. None of the SAEs in the apremilast group were reported more than once. Out of the five most common TEAEs in the 30 mg BID group, two (headache and Behçet’s syndrome/flare) were comparable to placebo, while nausea, diarrhea and vomiting were reported more frequently with APR 30 mg BID.
Limited therapies are available to treat this rare, chronic inflammatory disorder of unknown cause. The treatment options depend largely on the manifestations of the different organ systems involved. Treatment options recommended by physicians are largely aimed at alleviating specific patient symptoms and may include non-steroidal anti-inflammatory drug (NSAIDS), immunosuppressive medications and disease-modifying antirheumatic drugs (DMARDS) approved for other indications.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, is on-track for the fourth quarter of 2013. The Company is currently exploring opportunities to submit for an indication in Behçet’s disease in a number of countries.
About BCT-001
BCT-001 is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with two treatment arms (apremilast 30 mg BID and placebo) in Behçet’s disease. The study consisted of a 90-day pre-randomization phase, a 12-week treatment phase, a 12-week extension phase and a four-week post-treatment observational follow-up phase. A total of 111 subjects with active Behçet’s disease were randomized 1:1 to receive either apremilast 30 mg BID or identically appearing placebo, stratified by gender. The primary endpoint of the study was the number of oral ulcers at day 85 (12 weeks). Because virtually all patients with Behçet’s disease have painful oral ulcers, this manifestation was chosen as the primary efficacy measure. Less common manifestations of Behçet’s disease, including genital ulcers, skin lesions, inflammatory eye disease, involvement of the gastrointestinal, vascular and central nervous systems, and pain from oral and genital ulcers, were chosen as secondary/exploratory efficacy variables or safety measures.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Behçet’s Disease
Behçet’s disease is a chronic inflammatory vasculitis of unknown cause characterized by recurrent oral and genital ulcers, multiple skin lesions ranging from acne to vasculitic ulcerations, vascular involvement, including venous thrombosis and aneurysms which may be life threatening, and inflammatory disease of the eye manifesting as uveitis (may lead to blindness), neurologic involvement and gastrointestinal involvement. Prevalence of Behçet’s disease is highest in the Middle East, Asia and Japan, but it is classified as a rare or “orphan” disease by the NIH in the United States. At this time, there are limited therapies for this orphan indication in the United States or throughout Europe. In some cases, uncontrolled inflammation may lead to blindness, intestinal perforations, stroke, and even aneurismal bleeding which can be fatal. Although the root cause of Behçet’s disease is unknown, the disease is associated with abnormalities of the immune system. To learn more about the role of PDE4 in inflammatory diseases, visit www.discoverpde4.com.
About Celgene
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Celgene International Sàrl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8977/en
71% of patients achieved complete response at week 12 in clearing of ulcers
Apremilast also improved quality of life measures and pain associated with active oral ulcers, the cardinal manifestation of Behçet’s disease
Limited therapies currently available in U.S. or Europe for this orphan chronic inflammatory disorder
(BUSINESS WIRE)-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today presented phase II trial (BCT-001) results of apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), in patients with Behçet’s disease. The findings were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego. These results have been featured as part of the official ACR press program, which highlights data considered representative of the highest quality and most meaningful research presented at the ACR annual meeting.
Behçet’s disease is a rare and chronic inflammatory disorder characterized by recurrent oral and genital ulcers, skin and eye lesions (which may cause blindness) and joint inflammation. Inflammation may also affect the brain and gastrointestinal tract.
These data, which were also presented at the European League Against Rheumatism (EULAR) annual meeting this year in June, showed that significantly more patients on apremilast achieved a complete response (were free from active oral ulcers) at week 12 compared with those on placebo (apremilast, 71%; placebo, 29%; p<0.0001). Among patients with genital ulcers at baseline (n=16), 100% of those receiving apremilast had a complete response at week 12 compared with 50% of those receiving placebo (p=0.036).
“Behçet’s disease can have a severe negative impact on patients’ quality of life, and there are limited therapies available, so there is a clear need for a new therapy to help this patient population,” said Gulen Hatemi, M.D., Associate Professor, Cerrahpasa Medical School, Istanbul, Turkey. “We are encouraged by the rapid response seen in this important phase II study and by apremilast’s potential to treat oral ulcers in this orphan disease.”
The beneficial effect of apremilast on oral ulcers reached a stable effect within two weeks and was sustained while patients remained on treatment.
At week 12, apremilast also improved several patient-reported outcome scores, including the Behçet’s disease current activity form (BDCAF), Behçet’s syndrome activity score (BSAS) and Behçet’s disease quality of life (QoL) instrument. Improvement in oral ulcer pain was also significantly higher with apremilast than with placebo (apremilast, -44.7 ± 24.30; placebo, -16.0 ± 32.54; p<0.0001).
The type and severity of adverse events (AEs) were comparable to the known apremilast safety profile. In BCT-001, treatment-emergent adverse events (TEAE), including severe and serious adverse events (SAEs) and withdrawal due to adverse events, were comparable between 30 mg twice daily (BID) and placebo. None of the SAEs in the apremilast group were reported more than once. Out of the five most common TEAEs in the 30 mg BID group, two (headache and Behçet’s syndrome/flare) were comparable to placebo, while nausea, diarrhea and vomiting were reported more frequently with APR 30 mg BID.
Limited therapies are available to treat this rare, chronic inflammatory disorder of unknown cause. The treatment options depend largely on the manifestations of the different organ systems involved. Treatment options recommended by physicians are largely aimed at alleviating specific patient symptoms and may include non-steroidal anti-inflammatory drug (NSAIDS), immunosuppressive medications and disease-modifying antirheumatic drugs (DMARDS) approved for other indications.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 & 3 for psoriatic arthritis, were submitted to health authorities in the US and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, is on-track for the fourth quarter of 2013. The Company is currently exploring opportunities to submit for an indication in Behçet’s disease in a number of countries.
About BCT-001
BCT-001 is a phase 2, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with two treatment arms (apremilast 30 mg BID and placebo) in Behçet’s disease. The study consisted of a 90-day pre-randomization phase, a 12-week treatment phase, a 12-week extension phase and a four-week post-treatment observational follow-up phase. A total of 111 subjects with active Behçet’s disease were randomized 1:1 to receive either apremilast 30 mg BID or identically appearing placebo, stratified by gender. The primary endpoint of the study was the number of oral ulcers at day 85 (12 weeks). Because virtually all patients with Behçet’s disease have painful oral ulcers, this manifestation was chosen as the primary efficacy measure. Less common manifestations of Behçet’s disease, including genital ulcers, skin lesions, inflammatory eye disease, involvement of the gastrointestinal, vascular and central nervous systems, and pain from oral and genital ulcers, were chosen as secondary/exploratory efficacy variables or safety measures.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Behçet’s Disease
Behçet’s disease is a chronic inflammatory vasculitis of unknown cause characterized by recurrent oral and genital ulcers, multiple skin lesions ranging from acne to vasculitic ulcerations, vascular involvement, including venous thrombosis and aneurysms which may be life threatening, and inflammatory disease of the eye manifesting as uveitis (may lead to blindness), neurologic involvement and gastrointestinal involvement. Prevalence of Behçet’s disease is highest in the Middle East, Asia and Japan, but it is classified as a rare or “orphan” disease by the NIH in the United States. At this time, there are limited therapies for this orphan indication in the United States or throughout Europe. In some cases, uncontrolled inflammation may lead to blindness, intestinal perforations, stroke, and even aneurismal bleeding which can be fatal. Although the root cause of Behçet’s disease is unknown, the disease is associated with abnormalities of the immune system. To learn more about the role of PDE4 in inflammatory diseases, visit www.discoverpde4.com.
About Celgene
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Celgene International Sàrl
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8977/en
Moor Park Capital sells entire Banco Sabadell bank branch Portfolio to Mexican Investor Group backed by Moises El-Mann
ME Newswire / Businesswire
LONDON - Monday, October 28th 2013
Moor Park Capital LLP ("Moor Park Capital"), the London based specialists in European corporate finance led net lease real estate transactions for institutional and retail investors today announced that a group of Mexican investors led by Moisés El-Mann (the "Investors"), through the Mexican investment vehicle Branch Management, S.A.P.I. de C.V. ("Branch Management"), have acquired 100% of the share capital of the Spanish company ISC Fresh Water Investment, S.L.U. ("ISC Fresh Water"), owner of 253 bank branches in Spain, for a consideration of approx. EUR 290 million.
These bank branches, located throughout Spain with particular presence in Madrid and Barcelona, are let to Banco de Sabadell S.A. ("Banco Sabadell"), and represent one of the largest investments in the Spanish real estate market ever conducted by Mexican investors.
The bank branches have the benefit of a long term lease agreement with Banco Sabadell for an initial term of 25 years, put in place at the time the initial acquisition was closed by Moor Park Capital in April 2010, when 378 bank branches were acquired from Banco Sabadell. Since that time 125 bank branches have been successfully sold by Moor Park Capital to individual investors and the sale of the shares in ISC Freshwater completes the disposal process. Moor Park Capital have been retained by Branch Management as exclusive asset managers for the acquired bank branch portfolio. Clifford Chance (real estate and corporate/M&A), Garrigues (tax) and CBRE Spain advised Moor Park Capital on the sale and Banco Santander acted as financial advisors to the Investors and Uría Menéndez advised the Investors in relation to taxation and legal issues.
This transaction represents the first investment of a major acquisition plan for real estate investments to be undertaken by the Investors in Europe.
The Investors plan to continue their real estate investments in Spain and Europe to convert Branch Management into a SOCIMI, the Spanish legal entity equivalent to a REIT (Real Estate Investment Trust) in the near future.
About Moor Park Capital Partners:
Moor Park Capital Partners, led by its founding partners, Gary Wilder, Shemeel Khan and Jagdeep Kapoor specialises in strategically driven, corporate finance led, real estate monetization transactions including sale and leaseback transactions for corporates, governments, financial institutions and municipalities with single tenants and multiple high quality assets in Europe. Moor Park Capital acts on a discretionary and non-discretionary basis on behalf of a pool of investors - both retail and institutional, including Sovereign Wealth Funds - seeking asset-backed, secured fixed income style, inflation protected returns. It originates, structures and manages bespoke investments for its investors. The Moor Park Capital team has extensive European real estate experience and has undertaken or advised on c£20bn of transactions.
www.moorparkcapital.com
Contacts
Moor Park Capital LLP
Shemeel Khan/Javier Paz Valbuena, +442030111572
shemeel.khan@moorparkcapital.com
javier.paz@moorparkcapital.com
Permalink: http://www.me-newswire.net/news/8993/en
LONDON - Monday, October 28th 2013
Moor Park Capital LLP ("Moor Park Capital"), the London based specialists in European corporate finance led net lease real estate transactions for institutional and retail investors today announced that a group of Mexican investors led by Moisés El-Mann (the "Investors"), through the Mexican investment vehicle Branch Management, S.A.P.I. de C.V. ("Branch Management"), have acquired 100% of the share capital of the Spanish company ISC Fresh Water Investment, S.L.U. ("ISC Fresh Water"), owner of 253 bank branches in Spain, for a consideration of approx. EUR 290 million.
These bank branches, located throughout Spain with particular presence in Madrid and Barcelona, are let to Banco de Sabadell S.A. ("Banco Sabadell"), and represent one of the largest investments in the Spanish real estate market ever conducted by Mexican investors.
The bank branches have the benefit of a long term lease agreement with Banco Sabadell for an initial term of 25 years, put in place at the time the initial acquisition was closed by Moor Park Capital in April 2010, when 378 bank branches were acquired from Banco Sabadell. Since that time 125 bank branches have been successfully sold by Moor Park Capital to individual investors and the sale of the shares in ISC Freshwater completes the disposal process. Moor Park Capital have been retained by Branch Management as exclusive asset managers for the acquired bank branch portfolio. Clifford Chance (real estate and corporate/M&A), Garrigues (tax) and CBRE Spain advised Moor Park Capital on the sale and Banco Santander acted as financial advisors to the Investors and Uría Menéndez advised the Investors in relation to taxation and legal issues.
This transaction represents the first investment of a major acquisition plan for real estate investments to be undertaken by the Investors in Europe.
The Investors plan to continue their real estate investments in Spain and Europe to convert Branch Management into a SOCIMI, the Spanish legal entity equivalent to a REIT (Real Estate Investment Trust) in the near future.
About Moor Park Capital Partners:
Moor Park Capital Partners, led by its founding partners, Gary Wilder, Shemeel Khan and Jagdeep Kapoor specialises in strategically driven, corporate finance led, real estate monetization transactions including sale and leaseback transactions for corporates, governments, financial institutions and municipalities with single tenants and multiple high quality assets in Europe. Moor Park Capital acts on a discretionary and non-discretionary basis on behalf of a pool of investors - both retail and institutional, including Sovereign Wealth Funds - seeking asset-backed, secured fixed income style, inflation protected returns. It originates, structures and manages bespoke investments for its investors. The Moor Park Capital team has extensive European real estate experience and has undertaken or advised on c£20bn of transactions.
www.moorparkcapital.com
Contacts
Moor Park Capital LLP
Shemeel Khan/Javier Paz Valbuena, +442030111572
shemeel.khan@moorparkcapital.com
javier.paz@moorparkcapital.com
Permalink: http://www.me-newswire.net/news/8993/en
Oral Apremilast Demonstrated Clinically Meaningful and Statistically Significant Improvements in Enthesitis and Dactylitis
ME NewsWire / Business Wire
BOUDRY, Switzerland - Monday, October 28th 2013
At week 52, median percent improvement in swollen joint counts reached up to an 87.5% reduction and median percent improvement in tender joint count reached up to a 70.0% reduction
Significant and clinically meaningful improvements were shown in physical function at weeks 16 and 24 and were sustained over 52 weeks
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced research findings on apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), based on pooled data analyses from three randomized, controlled, phase III trials in psoriatic arthritis—PALACE 1, 2 and 3—at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
Pre-specified analyses from PALACE 1, 2 and 3 pooled data demonstrated that treatment with apremilast in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic disease, resulted in statistically significant and clinically meaningful improvements in enthesitis and dactylitis scores. At week 24, mean change from baseline in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) reached statistical significance for apremilast 30 mg twice daily (BID; -1.4 vs. -0.8 for placebo; p=0.0159), but not for apremilast 20 mg BID (-1.2; P=NS). At week 24, mean changes from baseline in dactylitis count (a count of fingers and toes with dactylitis) were -1.5 (P=NS) for apremilast 20 mg BID and -1.8 (P=0.0121) for apremilast 30 mg BID, versus -1.2 for placebo.
For those patients randomized to apremilast and completing 52 weeks of the study, the median percent change from baseline in MASES and dactylitis count were -66.7% and -100% for both apremilast treatment arms, respectively.
“Psoriatic arthritis is a serious, painful arthritic condition with signs and symptoms that can make day-to-day activities difficult and impede quality of life for many patients,” said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. “Data from these pooled phase III trials showed that apremilast treatment significantly controlled multiple manifestations of psoriatic arthritis and suggest apremilast may provide patients who are living with painful, persistent signs and symptoms of the disease with a new long-term treatment option.”
Patients treated with apremilast achieved significant reduction in number of swollen and tender joints after 16 weeks, which was maintained over 52 weeks.
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints and places where tendons and ligaments connect to bone, which can be potentially disabling if untreated. Results from all three of the PALACE studies (PALACE 1, 2 and 3) demonstrated that the number of swollen joints and the number of tender joints were both significantly reduced in patients with psoriatic arthritis who were treated with apremilast for 16 weeks compared with placebo.
These improvements were sustained over 52 weeks of treatment. Across all three studies, for those patients randomized to apremilast and completing 52 weeks of the study, the median percent reduction in swollen joint counts reached up to 87.5% and the median percent reduction in tender joint count reached up to 70.0%.
Statistically significant and clinically meaningful improvements in physical function were demonstrated after 16 and 24 weeks of treatment with apremilast 30 mg BID and were sustained over 52 weeks.
The results of physical function analyses from the PALACE 1, 2 and 3 studies demonstrated that 16 or 24 weeks’ treatment with apremilast 30 mg BID resulted in statistically significant and clinically meaningful improvements in physical function compared with placebo, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI; P≤0.03) and the short form health survey version 2 (SF-36 v2) Physical Functioning domain (PF; P≤0.05), in each of the three PALACE studies. Improvements were maintained or increased for those patients randomized to apremilast and completing 52 weeks of the study.
Apremilast demonstrated an acceptable safety profile, with no new safety findings, and was generally well-tolerated for up to 52 weeks. Most adverse events (AEs) were mild or moderate in severity and did not lead to discontinuation. The most common reported AEs were nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
About PALACE Program
PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent active treatment phase up to 52 weeks followed by a long-term safety phase in which all patients are treated with apremilast. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically appearing placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2 3 and 4 studies is the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at weeks 16 and 24.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. An estimated 125 million people worldwide have psoriasis, approximately 30 percent of whom may also develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common signs and symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
Permalink: http://www.me-newswire.net/news/8978/en
BOUDRY, Switzerland - Monday, October 28th 2013
At week 52, median percent improvement in swollen joint counts reached up to an 87.5% reduction and median percent improvement in tender joint count reached up to a 70.0% reduction
Significant and clinically meaningful improvements were shown in physical function at weeks 16 and 24 and were sustained over 52 weeks
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced research findings on apremilast, the Company’s first-in-class, oral, targeted inhibitor of phosphodiesterase 4 (PDE4), based on pooled data analyses from three randomized, controlled, phase III trials in psoriatic arthritis—PALACE 1, 2 and 3—at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in San Diego.
Pre-specified analyses from PALACE 1, 2 and 3 pooled data demonstrated that treatment with apremilast in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic disease, resulted in statistically significant and clinically meaningful improvements in enthesitis and dactylitis scores. At week 24, mean change from baseline in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) reached statistical significance for apremilast 30 mg twice daily (BID; -1.4 vs. -0.8 for placebo; p=0.0159), but not for apremilast 20 mg BID (-1.2; P=NS). At week 24, mean changes from baseline in dactylitis count (a count of fingers and toes with dactylitis) were -1.5 (P=NS) for apremilast 20 mg BID and -1.8 (P=0.0121) for apremilast 30 mg BID, versus -1.2 for placebo.
For those patients randomized to apremilast and completing 52 weeks of the study, the median percent change from baseline in MASES and dactylitis count were -66.7% and -100% for both apremilast treatment arms, respectively.
“Psoriatic arthritis is a serious, painful arthritic condition with signs and symptoms that can make day-to-day activities difficult and impede quality of life for many patients,” said Dafna Gladman, M.D., FRCPC, Professor of Medicine, University of Toronto. “Data from these pooled phase III trials showed that apremilast treatment significantly controlled multiple manifestations of psoriatic arthritis and suggest apremilast may provide patients who are living with painful, persistent signs and symptoms of the disease with a new long-term treatment option.”
Patients treated with apremilast achieved significant reduction in number of swollen and tender joints after 16 weeks, which was maintained over 52 weeks.
A characteristic of psoriatic arthritis is tenderness and swelling in and around the joints and places where tendons and ligaments connect to bone, which can be potentially disabling if untreated. Results from all three of the PALACE studies (PALACE 1, 2 and 3) demonstrated that the number of swollen joints and the number of tender joints were both significantly reduced in patients with psoriatic arthritis who were treated with apremilast for 16 weeks compared with placebo.
These improvements were sustained over 52 weeks of treatment. Across all three studies, for those patients randomized to apremilast and completing 52 weeks of the study, the median percent reduction in swollen joint counts reached up to 87.5% and the median percent reduction in tender joint count reached up to 70.0%.
Statistically significant and clinically meaningful improvements in physical function were demonstrated after 16 and 24 weeks of treatment with apremilast 30 mg BID and were sustained over 52 weeks.
The results of physical function analyses from the PALACE 1, 2 and 3 studies demonstrated that 16 or 24 weeks’ treatment with apremilast 30 mg BID resulted in statistically significant and clinically meaningful improvements in physical function compared with placebo, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI; P≤0.03) and the short form health survey version 2 (SF-36 v2) Physical Functioning domain (PF; P≤0.05), in each of the three PALACE studies. Improvements were maintained or increased for those patients randomized to apremilast and completing 52 weeks of the study.
Apremilast demonstrated an acceptable safety profile, with no new safety findings, and was generally well-tolerated for up to 52 weeks. Most adverse events (AEs) were mild or moderate in severity and did not lead to discontinuation. The most common reported AEs were nausea, diarrhea, headache, upper respiratory tract infection and nasopharyngitis.
These results are from investigational studies. Apremilast is not an approved product for any indication.
The New Drug Application (NDA) and the New Drug Submission (NDS), based on the combined data from PALACE 1, 2 and 3 for psoriatic arthritis, were submitted to health authorities in the U.S. and Canada in Q1 2013 and Q2 2013, respectively. An NDA to the U.S. Food and Drug Administration for psoriasis, in addition to a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe, are on-track for the fourth quarter of 2013.
About PALACE Program
PALACE 1, 2, 3 and 4 are the pivotal phase III multi-center, double-blind, placebo-controlled, parallel-group studies with two active-treatment groups. In PALACE 1, 2 and 3, approximately 1,500 subjects were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID or identically appearing placebo for 24 weeks, with a subsequent active treatment phase up to 52 weeks followed by a long-term safety phase in which all patients are treated with apremilast. The PALACE 1, 2 and 3 studies included a wide spectrum of patients with active psoriatic arthritis, including those who had been previously treated with oral DMARDs, and/or biologic DMARDs, including patients who had previously failed a tumor necrosis factor (TNF) blocker. PALACE 3 includes a large subset of patients with significant skin involvement with psoriasis.
In PALACE 4, more than 500 DMARD-naïve patients were randomized 1:1:1 to receive either apremilast 20 mg BID, 30 mg BID, or identically appearing placebo, for 24 weeks, with a subsequent active treatment phase up to 52 weeks, followed by a long-term safety phase in which all patients are treated with apremilast.
The primary endpoint of the PALACE 1, 2 3 and 4 studies is the modified American College of Rheumatology criteria for 20 percent improvement (ACR20) at week 16. Secondary endpoints include other measures of signs and symptoms, physical function and patient-reported outcomes at weeks 16 and 24.
Taken together, the PALACE program includes the most comprehensive psoriatic arthritis program to date intended for regulatory submission.
About Apremilast
Apremilast, an oral, targeted inhibitor of phosphodiesterase 4 (PDE4), intracellularly modulates the expression of a network of pro-inflammatory and anti-inflammatory cytokines. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, and other inflammatory cytokines. Elevation of cAMP also increases anti-inflammatory cytokines such as IL-10.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease associated with the skin condition psoriasis. An estimated 125 million people worldwide have psoriasis, approximately 30 percent of whom may also develop psoriatic arthritis. Psoriatic arthritis is a chronic disorder with progressive and additive joint inflammation that can lead to deleterious effects on quality of life and increases work disability. In addition to psoriatic skin lesions, common signs and symptoms of psoriatic arthritis include pain, stiffness and swelling in several to many joints, as well as inflammation of the spine. Patients often experience psoriasis on average for 10 years before the onset of joint symptoms, and many psoriatic arthritis patients go undiagnosed. To learn more about psoriatic arthritis, go to www.discoverpsa.com. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.
About Celgene
Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com.
Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
Contacts
Investors:
+41 32 729 8303 ir@celgene.com
Media:
+41 32 729 8304 media@celgene.com
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