Tuesday, January 31, 2017

Grundfos Launches Its First CRN Pumps Assembly Line in the Middle East

Dubai, United Arab Emirates -Tuesday, January 31st 2017 [ ME NewsWire ]

Grundfos, the award-winning world leader in advanced pump solutions, recently launched its first assembly line for CRN pumps in the Middle East. The opening of the assembly line located at the company’s facilities in Jebel Ali in Dubai comes following an extensive feasibility study that examined numerous product types.

In his remarks on the launch of the assembly line; Stewart Procter, Grundfos Senior Director Operations & Customer Service, Middle East noted: “Exceeding our client’s expectations is a main component of Grundfos philosophy. Therefore, and in order to maintain the maximum flexibility for our 13 countries, we recommended that the CRN pumps should be assembled in Grundfos facilities in the UAE rather than keeping finished stock units. The recommendations were approved by the Group’s headquarters.”

He continued: “The study we undertook concluded that we can increase sales of our CRN1-45 by 350 units in the first year alone. In case we applied further improvements and adhered to the set plans, this number could remarkably rise to an extra 2600 units by the fifth year.”

Notably, the approval for the assembly line was received at the end of August and the execution phase began through the VPC (Verification of product conformity) process immediately after. A small team in Grundfos was formed and included several departments such as the Product Management, Engineering, CSU (customer support unit), Quality and Production, along with several colleagues from the Group who provided help, guidance and the ultimate approval of the VPC.

The optimum mix of components had to be determined, ordered and shipped which takes six weeks transit time from Europe to Grundfos facilities in Jebel Ali. Various improvements to the test bed were made; lots of SAP data were entered; training sessions were organized; and production tools, printers, shelves and lifting tables were ordered as well.

“Whilst I would like to say it was a smooth process throughout the VPC. We did have several minor hiccups that were easily dealt with by our expert teams, and the first 14 pumps were ready by mid-December, and we were able to take some along to our Christmas party on 22nd December. “We can say now that we’re all set to start selling, 2017 started off with the first official GGD-assembled CRN order for one of our OEM customers,” concluded Procter.

About Grundfos

Founded in 1945 in Bjerringbro, a small town in Denmark, Grundfos has expanded its production to over 40 countries. Today Grundfos is represented by 19,000 employees in over 50 countries worldwide with revenue above €3 billion euro. Additionally, Grundfos has a strong local presence through its distributors and partners. With an annual production of more than 16 million pump units serving systems within buildings, industry, waste utilities, infrastructure, landscaping and water treatment, Grundfos is one of the world’s leading pump manufacturers and a trendsetter in water technology.

Setting the highest industry standards in energy efficient and sustainable pumping solutions is a key part of Grundfos’ foundation. Built on values and high ethics, Grundfos works with local communities and global society to resolve the world’s water and energy challenges. Grundfos has been present in the Middle East since the 1980s and today its regional headquarters are in the Jebel Ali Free Zone, one of the largest ports and Free Zones in the world. It has additional representative companies in KSA and Egypt, and branch offices throughout the region.



Gitte Borup Nielsen

Tel.:  +971 50 553 2540

Email: gnielsen@grundfos.com

Follow Grundfos Gulf Distribution at:

Website: http://ae.grundfos.com

Permalink : http://www.me-newswire.net/news/3272/en

Vice President Joe Biden to Deliver Keynote Remarks at 5th Annual World Patient Safety, Science & Technology Summit

IRVINE, Calif.-Tuesday, January 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- The Patient Safety Movement Foundation (PSMF) announced today that former Vice President Joe Biden will deliver the keynote address on the first day of the 5th Annual World Patient Safety, Science & Technology Summit to be held February 3rd & 4th 2017.

“We are honored to have Vice President Biden join us again and provide the keynote on the first day of our Summit,” stated Joe Kiani, Founder and Chairman of the Patient Safety Movement Foundation. “Vice President Biden has been a longtime supporter of the Patient Safety Movement and has transformed cancer research and collaboration. We hope one day due to his work, deaths due to cancer will be as preventable as deaths due to medical errors in hospitals.”

Last year, Patient Safety Movement awarded President Barack Obama and Vice President Joe Biden the Humanitarian Award for the Patient Protection and Affordable Care Acts (ACA). Not only has their work allowed more people to have access to healthcare, but through the new payment incentives, over 125,000 lives have been saved from preventable deaths.

The summit’s updated agenda link: http://patientsafetymovement.org/summit/world-patient-safety-science-and-technology-summit-2017/agenda-2017/

To request a press pass, please visit http://www.cvent.com/d/rfqhnq/4W. If you are part of the media but unable to attend the Summit but would like news updates, pictures, and video throughout the Summit, please email Irene@paigah.com.

About The Patient Safety Movement Foundation

More than 200,000 people die every year in U.S. hospitals and 3 million worldwide in ways that could have been prevented. The Patient Safety Movement Foundation was established through the support of the Masimo Foundation for Ethics, Innovation, and Competition in Healthcare, to reduce that number of preventable deaths to 0 by 2020 (0x2020). Improving patient safety will require a collaborative effort from all stakeholders, including patients, healthcare providers, medical technology companies, government, employers, and private payers. The Patient Safety Movement Foundation works with all stakeholders to address the problems and solutions of patient safety. The Foundation also convenes Patient Safety, Science and Technology summits. The Summits bring together some of the world’s best minds for thought-provoking discussions and new ideas to challenge the status quo. By presenting specific, high-impact recipes to meet patient safety challenges, called Actionable Patient Safety Solutions, encouraging medical technology companies to share the data for whom their products are purchased, and asking hospitals to make commitments to implement Actionable Patient Safety Solutions, Patient Safety Movement is working toward zero preventable deaths by 2020. Visit http://patientsafetymovement.org/.

@0X2020 #patientsafety #0X2020


Patient Safety Movement Foundation
Irene Paigah, 858-859-7001

Permalink : http://me-newswire.net/news/3276/en

FDA Approves First Balloon Expandable Stent Graft for Use in the Iliac Artery

 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Provides Improved Outcomes in Real-World Peripheral Arterial Disease Cases

FLAGSTAFF, Ariz. -Tuesday, January 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- W. L. Gore & Associates (Gore) has announced that the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) has received U.S. Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation. This marks the availability of the only balloon expandable stent graft with an indication for the iliac artery.

“The VBX Stent Graft demonstrated notable immediate and nine-month safety and efficacy in treating patients with iliac occlusive disease which can be attributed to the exceptional device design,” said Jean Bismuth, MD. Dr. Bismuth continued, “Overall, there were multiple clinical benefits observed, including no median change in the device length upon deployment and a 100 percent technical success rate with no occurrences of stent dislodgement or significant residual stenosis. The study device performed well in disadvantaged lesions, including occlusions, which speaks to its trackability, radial strength, conformability, and stent retention.”

Gore VBX FLEX IDE Clinical Study

Of the patients in the Gore VBX FLEX IDE clinical study (n=134), 32 percent presented with TASC II type C or D lesions, 18 percent required contralateral access to the lesion, and 42 percent involved kissing stents at the aortic bifurcation. Clinical data from the Gore VBX FLEX IDE clinical study conducted for FDA approval reflected that the design components of the VBX Stent Graft were resilient both during stenting procedures and over time:

    100 percent success rate in device delivery and coverage of target lesions in all study subjects;
    100 percent success rate in reducing the target lesion to less than or equal to 30 percent of the original stenosis;
    Zero change in median length of the device upon deployment; and
    96.9 percent primary patency at nine-months, including a 95.3 percent primary patency rate in those patients with TASC II C or D type lesions.

Further, there were no reported incidences of device dislodgement, failures in stent integrity, or device-related serious adverse events through the primary endpoint follow up, meaning no additional costs incurred for either endovascular or surgical stent removal. The VBX Stent Graft does not require pre-dilation, which reduces the number of balloons required, and the longer lengths available reduce the need to use multiple stents for extensive lesions, both of which also contribute to procedural cost savings.


“The VBX Stent Graft combines radial strength with trackability and implanted conformability that results in successful outcomes for patients, providers and physicians,” said Ray Swinney, Peripheral Interventional Business Leader at Gore.

The VBX Stent Graft was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 to 11 millimeters and lengths of 15, 19, 29, 39, 59, and 79 millimeters to cover a wide variety of treatment needs.

Gore provides a portfolio of peripheral vascular solutions that are designed and tested so physicians can more reliably treat patients with a wide range of challenging peripheral disease presentations and improve those patients’ outcomes. Each interventional solution is engineered for durability, accuracy, thromboresistance and conformability, and is backed by dedicated service to help improve patient outcomes.

For more information, visit goremedical.com/vbx


At Gore, we have provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are one of a select few companies to appear on all of the U.S. “100 Best Companies to Work For” lists since the rankings debuted in 1984.

Products listed may not be available in all markets. GORE®, VBX, and VIABAHN® are trademarks of W. L. Gore & Associates.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170130005288/en/


Bliss Integrated Communication for Gore Medical
Victoria Aguiar
Liz DeForest

Permalink : http://me-newswire.net/news/3278/en

Exelixis and Takeda Enter into Exclusive Licensing Agreement to Commercialize and Develop Novel Cancer Therapy Cabozantinib in Japan

 – Takeda’s Rights to Include all Potential Indications for Cabozantinib, which is Marketed in the U.S. and European Union for Renal Cell Carcinoma and Medullary Thyroid Carcinoma –

SOUTH SAN FRANCISCO, Calif. & CAMBRIDGE, Mass. & OSAKA, Japan -Tuesday, January 31st 2017 [ ME NewsWire ]

– Exelixis Receives $50 Million Upfront Payment and is Eligible for Future Regulatory and Commercial Milestones –

(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ:EXEL) and Takeda Pharmaceutical Company Limited (TSE:4502) today announced an exclusive licensing agreement for the commercialization and further clinical development in Japan of cabozantinib, Exelixis’ lead oncology medicine. With the signing of the agreement, Takeda gains exclusive commercial rights for all potential future cabozantinib indications in Japan, including advanced renal cell carcinoma (RCC), for which cabozantinib is marketed in the United States and European Union as CABOMETYX™ tablets. The two companies will collaborate on the future clinical development of cabozantinib in Japan.

Under the terms of the agreement, Exelixis will receive a $50 million upfront payment. Exelixis is eligible to receive development, regulatory, and first-sales milestones of $95 million for the first three planned indications. In addition, Exelixis will be eligible to receive royalties on sales by Takeda.

“As an organization with a strong focus on oncology innovation, our agreement with Exelixis brings a promising and well-studied solid-tumor therapy to our pipeline that may help patients in Japan suffering from RCC and potentially other equally devastating cancers,” said Tsudoi Miyoshi, Head of Japan Oncology Business Unit of Takeda. “We intend to pursue regulatory approval for RCC indications as soon as we’re able, and look forward to commencing the local clinical trial program to further strengthen the clinical profile of cabozantinib.”

Exelixis and Takeda will partner on cabozantinib’s clinical development in Japan and on translating existing and forthcoming clinical data for potential regulatory filings in the country. In the METEOR pivotal trial, cabozantinib demonstrated statistically significant improvements in overall survival, progression-free survival and objective response rate, meaningfully differentiating it from other therapies to treat advanced renal cell carcinoma following prior therapy. In addition to advanced RCC, future indications could include advanced hepatocellular cancer (HCC), the subject of the CELESTIAL global pivotal trial for which results are anticipated in 2017. Additional earlier-stage studies are under way through Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program, and its ongoing Investigator-Sponsored Trial program. Through these two programs, there are more than 45 ongoing or planned studies including trials in advanced RCC, bladder cancer, colorectal cancer, non-small cell lung cancer, and endometrial cancer.

“Takeda is the ideal partner to advance cabozantinib in Japan and deliver this important treatment option to Japanese patients with cancer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “Takeda is widely respected for both its clinical development and commercial expertise. We look forward to supporting our new partner as it pursues Japanese regulatory approval for cabozantinib, while simultaneously working together to plan the next steps for clinical development in the country. This agreement further propels the global progress for cabozantinib development and commercialization, which now includes the recent first commercial sale of CABOMETYX in the United Kingdom, triggering a $10 million milestone payment from Ipsen to Exelixis.”

Cabozantinib is not approved for use in Japan. Previously, Exelixis and its collaborators conducted early-stage clinical trials in Japan, including a phase 1 trial in advanced solid tumors. Data from this trial were presented at the European Society for Medical Oncology 2012 Congress and the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.1,2

Exelixis maintains its exclusive rights to develop and commercialize cabozantinib in the United States, and its partner Ipsen maintains its exclusive commercialization rights for current and potential future cabozantinib indications outside of the United States and Japan.

About CABOMETYX™ (cabozantinib) Tablets

CABOMETYX is the tablet formulation of cabozantinib. Its targets include MET, AXL, and VEGFR-1, -2 and -3. In preclinical models, cabozantinib has been shown to inhibit the activity of these receptors, which are involved in normal cellular function and pathologic processes such as tumor angiogenesis, invasiveness, metastasis, and drug resistance.

CABOMETYX is available in 20 mg, 40 mg or 60 mg doses. The recommended dose is 60 mg orally, once daily.

On April 25, 2016, the FDA approved CABOMETYX tablets for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. On September 9, 2016, the European Commission approved CABOMETYX tablets for the treatment of advanced renal cell carcinoma in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy in the European Union, Norway and Iceland. On February 29, 2016, Exelixis and Ipsen jointly announced an exclusive licensing agreement for the commercialization and further development of cabozantinib indications outside of the United States, Canada and Japan. On December 21, 2016, Exelixis and Ipsen jointly announced an amendment to their exclusive licensing agreement for the commercialization and development of cabozantinib to include Canada.

U.S. Important Safety Information

Hemorrhage: Severe hemorrhage occurred with CABOMETYX. The incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also occurred in the cabozantinib clinical program. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.

Gastrointestinal (GI) Perforations and Fistulas: Fistulas were reported in 1.2% (including 0.6% anal fistula) of CABOMETYX-treated patients and 0% of everolimus-treated patients. GI perforations were reported in 0.9% of CABOMETYX-treated patients and 0.6% of everolimus-treated patients. Fatal perforations occurred in the cabozantinib clinical program. Monitor patients for symptoms of fistulas and perforations. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.

Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. Venous thromboembolism was reported in 7.3% of CABOMETYX-treated patients and 2.5% of everolimus-treated patients. Pulmonary embolism occurred in 3.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Events of arterial thromboembolism were reported in 0.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.

Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension. Hypertension was reported in 37% (15% Grade ≥3) of CABOMETYX-treated patients and 7.1% (3.1% Grade ≥3) of everolimus-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.

Diarrhea: Diarrhea occurred in 74% of patients treated with CABOMETYX and in 28% of patients treated with everolimus. Grade 3 diarrhea occurred in 11% of CABOMETYX-treated patients and in 2% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to diarrhea occurred in 26% of patients.

Palmar-Plantar Erythrodysesthesia Syndrome (PPES): Palmar-plantar erythrodysesthesia syndrome (PPES) occurred in 42% of patients treated with CABOMETYX and in 6% of patients treated with everolimus. Grade 3 PPES occurred in 8.2% of CABOMETYX-treated patients and in <1% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPES or Grade 3 PPES until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to PPES occurred in 16% of patients.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-fetal Toxicity: CABOMETYX can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.

Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting, weight decreased, and constipation.

Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.

Lactation: Advise a lactating woman not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose.

Reproductive Potential: Contraception―Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the final dose. Infertility ―CABOMETYX may impair fertility in females and males of reproductive potential.

Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-Pugh score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see full Prescribing Information at https://cabometyx.com/downloads/cabometyxuspi.pdf.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as our presence in Emerging Markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

About Exelixis

Exelixis, Inc. (Nasdaq:EXEL) is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines with the potential to improve care and outcomes for people with cancer. Since its founding in 1994, three medicines discovered at Exelixis have progressed through clinical development to receive regulatory approval. Currently, Exelixis is focused on advancing cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL and VEGF receptors, which has shown clinical anti-tumor activity in more than 20 forms of cancer and is the subject of a broad clinical development program. Two separate formulations of cabozantinib have received regulatory approval to treat certain forms of kidney and thyroid cancer and are marketed for those purposes as CABOMETYX™ tablets (U.S. and EU) and COMETRIQ® capsules (U.S. and EU), respectively. Another Exelixis-discovered compound, COTELLIC® (cobimetinib), a selective inhibitor of MEK, has been approved in major territories including the United States and European Union, and is being evaluated for further potential indications by Roche and Genentech (a member of the Roche Group) under a collaboration with Exelixis. For more information on Exelixis, please visit www.exelixis.com or follow @ExelixisInc on Twitter.

Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the future clinical development of cabozantinib by Exelixis and Takeda in Japan; Exelixis’ receipt of a $50 million upfront payment; Exelixis’ eligibility to receive development, regulatory and first-sales milestones of $95 million for the first three planned indications; Exelixis’ eligibility to receive royalties on sales of cabozantinib by Takeda; the clinical and therapeutic potential of cabozantinib for patients in Japan suffering from RCC and potentially other cancers; Takeda’s intent to pursue regulatory approval for cabozantinib in RCC indications and commence a local clinical trial program; Exelixis’ and Takeda’s plan to translate existing and forthcoming clinical data for potential regulatory filings in Japan; advanced HCC as a potential future commercial indication; the timing of anticipated results from CELESTIAL; the continued development of cabozantinib through Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program, and its ongoing Investigator-Sponsored Trial program; Exelixis’ intent to support Takeda as it pursues Japanese regulatory approval for cabozantinib, while simultaneously working together to plan the next steps for clinical development in Japan; Exelixis' commitment to the discovery, development and commercialization of new medicines with the potential to improve care and outcomes for people with cancer; Exelixis’ focus on advancing cabozantinib; and the continued development of cobimetinib. Words such as “potential,” “further,” “will,” “eligible,” “planned,” “may,” “intend,” “look forward,” “future,” “could,” “anticipated,” “next,” “committed,” “focused,” or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the complexities and challenges associated with regulatory review and approval processes; Exelixis’ dependence on its relationship with Takeda, including, the level of Takeda’s investment in the resources necessary to successfully commercialize cabozantinib in Japan; the degree of market acceptance of CABOMETYX and the availability of coverage and reimbursement for CABOMETYX; the risk that unanticipated developments could adversely affect the commercialization of CABOMETYX; Exelixis’ ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; Exelixis’ dependence on its relationship with other collaborators, including Ipsen with respect to cabozantinib in territories outside of the United States and Japan and Genentech/Roche with respect to cobimetinib; Exelixis’ dependence on third-party vendors; Exelixis’ ability to protect the company’s intellectual property rights; market competition; changes in economic and business conditions, and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 3, 2016, and in Exelixis’ future filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Exelixis, the Exelixis logo, COMETRIQ and COTELLIC are registered U.S. trademarks,

and CABOMETYX is a U.S. trademark.

1 Nokihara et al., Molecular profile and anti-tumor activity in non-small cell lung cancer (NSCLC) patients (pts) in a phase 1 study of cabozantinib (XL184) in Japan. Ann Oncol. 2012; 23 (suppl 9): ix152-ix174.

2 Nokihara et al., Final results of a phase 1 study of cabozantinib (Cabo) in Japanese patients (pts) with expansion cohorts in non-small cell lung cancer (NSCLC) with defined molecular alterations. Mol Cancer Ther. December 1 2015 (14) (12 Supplement 2) B179.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170130006192/en/


Exelixis Contacts
Financial Community:
Susan Hubbard, 650-837-8194
EVP, Public Affairs and Investor Relations
For Exelixis, Inc.
Hal Mackins, 415-994-0040
Takeda Contacts
Japanese Media:
Tsuyoshi Tada, +81 (0) 3-3278-2417
Media Outside Japan:
Amy Atwood, +1 617-444-2147

Permalink : http://www.me-newswire.net/news/3279/en 

SES and Satcom Global sign an agreement for global Ku-band network

LUXEMBOURG-Tuesday, January 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- SES S.A. (Euronext Paris:SESG) (LuxX:SESG) announced today that Satcom Global, a leading provider of global satellite communications services to the maritime and land sectors, will become a key partner for SES. The differentiated mobility solution will form a crucial part of Satcom Global’s new Ku-band VSAT service, Aura, providing seamless, reliable and high-speed connectivity to hundreds of maritime, offshore and land customers.

The agreement provides Satcom Global with seamless access to SES's satellite fleet and upcoming next generation hybrid satellites with high throughput payloads. SES will also provide a robust ground network infrastructure, enabling multi-satellite access and service integration solutions.

SES will provide Satcom Global with an open and scalable VSAT platform that allows flexibility to deliver customisable, always-on broadband connectivity. SES delivers high-value performance with minimal initial investment cost and enables Satcom Global to scale-up service for customers without delay.

“SES is the ideal partner for Satcom Global. The current footprint, augmented by a series of high throughput beams over the next two years, makes SES the logical choice to support Aura, our global VSAT service offering. The coverage, capacity and flexibility provided by the SES service is the perfect platform for Satcom Global to develop the type of VSAT offering our customers have been waiting for,” said Ben Swallow, General Manager, VSAT, at Satcom Global.

Ferdinand Kayser, Chief Commercial Officer at SES, said: “From providing access to entertainment for crew welfare to driving operational efficiencies, connectivity needs across a wide variety of sectors are growing, and SES aims to help meet that demand across the world. Leveraging SES’s global satellite fleet, upcoming HTS capacity, and extensive ground infrastructure, Satcom Global will benefit fully from customisable bandwidth and coverage, and ensure efficient utilisation of satellite capacity.”

Follow us on:

Twitter: https://twitter.com/SES_Satellites

Facebook: https://www.facebook.com/SES.Satellites

YouTube: http://www.youtube.com/SESVideoChannel

Blog: https://www.ses.com/news/blogs

SES White papers are available under https://www.ses.com/news/whitepapers

About SES

SES is the world-leading satellite operator and the first to deliver a differentiated and scalable GEO-MEO offering worldwide, with more than 50 satellites in Geostationary Earth Orbit (GEO) and 12 in Medium Earth Orbit (MEO). SES focuses on value-added, end-to-end solutions in four key market verticals (Video, Enterprise, Mobility and Government). It provides satellite communications services to broadcasters, content and internet service providers, mobile and fixed network operators, governments and institutions, and businesses worldwide. SES’s portfolio includes the ASTRA satellite system, which has the largest Direct-to-Home (DTH) television reach in Europe, and O3b Networks, a global managed data communications service provider. Another SES subsidiary, MX1, is a leading media service provider and offers a full suite of innovative digital video and media services. Further information available at: www.ses.com

About Satcom Global

Satcom Global is a leading provider of global satellite services to the maritime, land and aero markets, and a trusted supplier of marine and offshore safety systems and engineering services. We provide voice and data solutions for users in remote locations outside terrestrial networks, and design and integrate systems ensuring safety in the most hazardous of environments. With sales and support hubs across Asia, Australia, Europe and the US, we invest significantly in our people as well as the development of technical solutions and infrastructure to ensure we can provide the best innovative solutions to our customers, with a smile. www.satcomglobal.com More information about the Satcom Global Aura service can be found at http://www.satcomglobal.com/aura-vsat including hardware specifications, solution packages and full details on VSAT engineering and installation.


For further information please contact:
Markus Payer
Corporate Communications
Tel. +352 710 725 500

Permalink : http://me-newswire.net/news/3273/en

Ascend Performance Materials Announces Global Price Increase for All Vydyne® Brand Polymers

HOUSTON-Tuesday, January 31st 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Ascend Performance Materials announced today a global price increase for all of its Vydyne® branded polymers.

The price increase takes effect February 1, or as contracts allow and includes the following price changes:

Materials Geography Price Increase Terms

Ascend Vydyne®
(PA 66) polymers North America $0.15/lb As contracts allow
Non-contract business – price determined on an order-by-order basis

Ascend Vydyne®
(PA 66) polymers Asia $0.33/kg As contracts allow
Non-contract business – price determined on an order-by-order basis

Ascend Vydyne®
(PA 66) polymers Europe €0.30/kg As contracts allow
Non-contract business – price determined on an order-by-order basis

Customers should contact their local sales representative for additional information.

NOTE TO EDITORS: ASCEND PERFORMANCE MATERIALS is a trademark of Ascend Performance Materials Operations LLC. This trademark has been registered in jurisdictions throughout the world, including the United States of America.

About Ascend Performance Materials
Ascend Performance Materials is a global premium provider of high-quality chemicals, fibers and plastics. Ascend is one of the world’s largest integrated PA66 producers, with its own in-house manufacturing facilities, ensuring total security of supply. Ascend’s product range has earned it an unequalled reputation for quality, innovative techniques and an enlightened approach to business that expands the horizons of possibility. With eight global locations and more than 3,200 people working at our sites around the world, Ascend has the inspiration, the expertise, the people and the attitude toward innovation to consistently deliver the right solution for customers.

Together, we’re making a difference.
Together, we’re inspiring everyday.

More information about Ascend can be found at www.ascendmaterials.com

About SK Capital
SK Capital is a private investment firm with a disciplined focus on the specialty materials, chemicals and healthcare sectors. The firm’s purpose is to build strong and growing businesses that create substantial long-term economic value. SK utilizes its industry, operating and investment experience to identify opportunities to transform businesses into higher performing organizations with improved strategic positioning, growth and profitability as well as lower operating risk. SK Capital’s portfolio companies generate revenues of approximately $8 billion annually and employ approximately 9,000 people. The firm currently manages more than $1.5 billion of committed capital. For more information, please visit www.skcapitalpartners.com


Ascend Performance Materials
Alison Jahn, +1 713-210-9809

Permalink : http://www.me-newswire.net/news/3275/en

Monday, January 30, 2017

Ferring Pharmaceuticals and Enteris BioPharma Enter License Agreement to Develop an Oral Formulation of a Peptide-based Injectable Therapeutic

SAINT-PREX, Switzerland-Monday, January 30th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Ferring Pharmaceuticals and Enteris BioPharma, Inc. announced today that the companies have entered into a license agreement and initiated an early development agreement to leverage Enteris’ proprietary and patented oral peptide and small molecule delivery platform, Peptelligence™, to engineer an oral formulation of a peptide-based injectable therapeutic developed by Ferring.

Under the terms of the agreement, Enteris BioPharma will license to Ferring its oral drug delivery technologies, as well as provide clinical trial finished product, and will receive milestones and royalties based on net sales of the developed product.

The licensing agreement with Ferring Pharmaceuticals highlights Enteris BioPharma’s successful “Feasibility-to-Licensing” strategy involving Peptelligence™, its peptide and small molecule oral drug delivery platform. The technology is currently the subject of several active external development programs and has proven effective over the last decade to enable the safe delivery of peptide-based therapeutics and other molecules with low oral bioavailability.

Joel Tune, Chief Executive Officer and Executive Chairman of Enteris BioPharma, remarked, “Our agreement with Ferring Pharmaceuticals exemplifies the opportunity our Peptelligence platform offers in enhancing the market potential of peptide-based therapeutics by enabling the oral delivery of medications that must otherwise be administered by injection. We are excited to work with an industry leader like Ferring Pharmaceuticals to advance the development of an oral peptide-based therapeutic.”

Alan Harris, Senior Vice President, R&D Executive Office of Ferring Pharmaceuticals, remarked, “The ability to deliver oral peptides offers Ferring the opportunity to provide additional therapeutic choices to patients. We are impressed with Enteris’ proprietary oral delivery technology and look forward to working with them to advance this development program.”


About Ferring Pharmaceuticals

Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

About Enteris BioPharma

Enteris BioPharma, Inc. is a privately held, New Jersey-based biotechnology company offering innovative formulation solutions built around its proprietary drug delivery technologies. The Company’s proprietary oral delivery technology – Peptelligence™ - has been the subject of numerous feasibility studies and active development programs, several of which are in late stage clinical development. Additionally, Enteris BioPharma has built and is advancing an internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities for which there is no oral delivery option. Enteris BioPharma’s most advanced internal product candidate, Ovarest™ (oral leuprolide tablet), is a Phase 2a-ready oral peptide, being developed for the treatment of endometriosis. For more information on Enteris BioPharma and its proprietary oral delivery technology and contract manufacturing capabilities, please visit www.enterisbiopharma.com.


Ferring Pharmaceuticals
Lindsey Rodger
Tel. +41 58 451 40 23
Enteris BioPharma:
Brian Zietsman, President & CFO
+1 973 453 3527
Enteris Media Relations:
Jason Rando / Amy Wheeler
Tiberend Strategic Advisors, Inc.
+1 212 827 0020

Permalink : http://www.me-newswire.net/news/3271/en

712 cross the vertical line at the inaugural Climb to Abu Dhabi

ABU DHABI, United Arab Emirates -Monday, January 30th 2017 [ ME NewsWire ]

Under the initiative of the Abu Dhabi Sports Council, The Climb to Abu Dhabi Vertical Marathon presented by Daman’s ActiveLife was held at the iconic Etihad Towers on Friday the 27th of January 2017. A total of 712 participants took up the challenge across 6 different race categories climbing 82 Floors / 1,617 Steps or 32 Floors / 720 Steps with winners taking home $25,000 USD in prize money.

Speaking at the event H.E Aref Hamad Al Awani, Secretary General of the Abu Dhabi Sports Council, commented, “Stair climbing is one of the best forms of exercise and the easiest way to work fitness into our busy lives. We are delighted with the inaugural event and encourage everyone to join the stair climbing movement not just from today but into the future.”

Brand Ambassador of the event and current World Champion, Piotr Lobodzinski expressed his delight at the engagement of the community and worlds best runners, he stated “The Climb to Abu Dhabi was a very new race for many of today’s participants. Its fantastic to see such a great response which hopefully sees the sport of tower running become even more popular in the Middle East Region.”

Christian Riedl winner of the men’s elites category, and current world number 2 ranked tower runner expressed his delight at crossing the vertical line in the ultimate winning time of 9mins and 21seconds. He stated “I am very happy to win the event, obviously with such prize money on stake we had a strong field so to hear my name announced as the winner was a great feeling. The race itself was considerably difficult with a fast track approaching the stairs but overall a fantastic event and look forward to defending my title next year already.”

Australia’s world champion Suzy Walsham whom took home the Female Elite title in an impressive 10mins and 30seconds was also delighted with her performance, stating “what a wonderful event to see so many of the community take part in tower running. Today’s event was a good test as it was a building that no one has ever run up. Delighted to take home the title and look forward to seeing many more of the Abu Dhabi community take on the challenge next year.”

Richard Foulds, Head of Property Management at Etihad Towers; the home of the Climb to Abu Dhabi, stated “on behalf of His Highness Sheikh Suroor Bin Mohammed Al Nahyan, it was a pleasure for the 2017 “Climb to Abu Dhabi Vertical Marathon” to be hosted at the iconic Etihad Towers in conjunction with Abu Dhabi’s sports council, Daman Health Insurance and of course our hotel partners Jumeirah Group.

Tower 2, where this year’s event took place, is one of three residential towers, measuring 310m in height and remains one of the tallest iconic residential towers in Abu Dhabi. The event also happily coincides with the 5th anniversary of the opening of Etihad Towers, which remains the largest mixed use development in Abu Dhabi. It was a pleasure for Etihad Towers for Real Estate (ETRE) to award Ms. Alice McNamara, who flew in all the way from Sydney Australia, the trophy and prize money for coming runner up in the female elite category

On behalf of His Highness Sheikh Suroor and the Etihad Towers team, we would like to thank all the supporters and participants both professional athletes and family & friends and welcome them back to Etihad Towers Abu Dhabi for next year’s edition.

An exhibition race in 2017 under the sanctioning of the World Tower Running Association, the Climb to Abu Dhabi is also the first destination city for the newly formed Climb to Vertical Series, which will see cities around the Middle East & North Africa form part of the a MENA vertical series to launch in 2018.

An initiative of the Abu Dhabi Sports Council and presented by Daman’s ActiveLife, the Climb to Abu Dhabi is hosted and sponsored by Etihad Towers and supported by Reebok, Etisalat, Technogym, National Ambulance, Jumeirah at Etihad Towers and Sport360.

Further details including full results and partners are available on www.climbtoabudhabi.com.


- Results of winners below

2017 Winning Prize Money Results - 82 Floors / 1,617 Steps

Elite Male (34 starters)



Final Time

Prize Money



Christian  Riedl





Tomas  Celko





Shaun  Stephens-Whale





Emanuele  Manzi





Stefan  Stefina





Gorge Heimann





Karol  Galicz





Henry  Kipkurui Kipsang





Rolf  Majcen





Ralf  Hascher




Elite Female (16 starters)



Final Time

Prize Money



Suzy Walsham





Alice McMamara





Brooke Logan





 Zuzana Krchova





Lenka Svabikova




Challenger Male (169 starters)



Final Time

Prize Money


Ismail Ssenyanga




Paul Faulkner




Pierluca Armati




Abdelali Bouazzaoui




Abdelmajid Elakhdar



Challenger Female (108 starters)



Final Time

Prize Money


Euliter Jepchirchir Tanui




Amina Mhih




Rebecca Faulkner




Nicoleta Hodorogea




Toni Metcalfe




Sport 360

Mark Kar


Climb to Series, +971 55 696 3257


Permalink : http://me-newswire.net/news/3270/en

Celgene Receives Positive CHMP Opinion to Expand REVLIMID® (Lenalidomide) Indication as Monotherapy for the Maintenance Treatment of Patients with Newly Diagnosed Multiple Myeloma (MM) after Autologous Stem Cell Transplantation

 • REVLIMID® is the first and only medicine granted positive CHMP opinion for post-Autologous Stem Cell Transplantation (ASCT) maintenance therapy in MM

• The new indication expands the availability of REVLIMID® across the disease continuum of MM

BOUDRY, Switzerland-Monday, January 30th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID® as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation (ASCT). Once approved by the European Commission, REVLIMID® will be the first and only licensed maintenance treatment available to these patients.

Multiple myeloma is an incurable and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system.1 It is a rare but deadly disease—around 39,000 people are diagnosed with MM in Europe, and around 24,000 people die from the disease each year.2 The median age at diagnosis in Europe is between 65 and 70 years.3 In Europe, patients who are under 65 years, fit and in good clinical condition are typically considered eligible for ASCT.4

For newly diagnosed, transplant-eligible MM patients, key treatment goals are to obtain and to maintain a deep response to therapy, with the ultimate objective of delaying disease progression.5,6 These patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT. This treatment approach has been an established standard of care for over 20 years.7 Considering that over half of patients relapse within 2 to 3 years after ASCT,8,9 trials have been conducted to assess whether maintenance therapy following ASCT could enable more durable remissions.

“Studies show that maintenance treatment after ASCT with REVLIMID® may help control residual malignant cells and delay tumour growth by enhancing immune function,” says Professor Michel Attal, Executive Director of the Institut Universitaire du Cancer Toulouse Oncopole and Institut Claudius Regaud, France. “Our primary goal is to delay disease progression for as long as possible, and we have seen in several independent studies, that REVLIMID® maintenance after ASCT can halve the risk of disease progression by sustaining the response.”

The CHMP recommendation was based on the results of two cooperative group-led studies, CALGB 10010410 and IFM 2005-0211:

    CALGB 100104 was a phase III, controlled, double-blind, multi-centre study of 460 patients with newly diagnosed MM undergoing ASCT who received continuous daily treatment with REVLIMID® or placebo until relapse.
    IFM 2005-02 was an international, phase III, controlled, double-blind, multi-centre study of 614 patients newly diagnosed with MM who were randomized to receive a 2-month consolidation regimen post-ASCT of REVLIMID® monotherapy, followed by continuous daily treatment with either REVLIMID® or placebo until relapse.

In the two phase III studies, REVLIMID® monotherapy as maintenance treatment post-ASCT significantly reduced the risk of disease progression or death in patients with MM, leading to the studies being unblinded based on passing their pre-specified boundary for superiority at interim analysis.

In these studies, the safety profile was in line with other clinical data in newly diagnosed non-stem cell transplant (NSCT) and post-approval safety study in relapsed/refractory MM (rrMM). Across both phase III clinical studies, the most commonly reported adverse events (AE) were haematological and included neutropenia and thrombocytopenia. The most commonly reported non-haematological AE were infections. In both trials, an increased incidence rate of haematologic second primary malignancies (SPMs) has been observed in the REVLIMID® group compared with the placebo group. However, the CHMP positive opinion confirms that the benefit-risk ratio for REVLIMID® is positive in this expanded indication.

Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “Despite substantial progress made so far in multiple myeloma treatment, it remains an incurable disease. We welcome this CHMP opinion as it confirms the important role that REVLIMID® plays in treating multiple myeloma, extending the use of REVLIMID® across the disease continuum. At Celgene, we aspire to turn some of the most challenging diseases, like multiple myeloma, into manageable conditions. Therefore, we will continue to invest more than one-third of our revenues back into research and development.”

The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

About CALGB 100104

CALGB 100104 was a phase III, randomised, controlled, double-blind, multi-centre study conducted in 47 centres in the United States. 460 newly diagnosed multiple myeloma patients – aged between 18 and 70 years - who achieved at least stable disease (SD) or better 100 days after undergoing autologous stem cell transplant (ASCT), were randomised to receive either REVLIMID® maintenance (10 mg/day for 3 months, then 15 mg/day) or placebo until disease progression, intolerable side effects or death.

About IFM 2005-02

IFM 2005-02 was a phase III, controlled, double-blind, multi-centre study conducted in 77 centres across 3 countries in Europe. 614 newly diagnosed multiple myeloma patients younger than 65 years without signs of disease progression within 6 months of undergoing ASCT, were then randomised to receive a two-month consolidation regimen of REVLIMID® monotherapy 25 mg per day on 21/28 days, followed by either REVLIMID® maintenance (10 mg/day for 3 months, then 15 mg/day) or placebo until disease progression, intolerable side effects or death.


REVLIMID® in combination with dexamethasone is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant. REVLIMID® is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID® is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMID® is approved in Europe and in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.



REVLIMID® (lenalidomide) is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients in the formulation.

REVLIMID® (lenalidomide) is contraindicated during pregnancy, and also in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.

Warnings and precautions

Pregnancy: the conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.

Cardiovascular disorders: patients with known risk factors for myocardial infarction or thromboembolism should be closely monitored.

Neutropenia and thrombocytopenia: complete blood cell counts should be performed every week for the first 8 weeks of treatment and monthly thereafter to monitor for cytopenias. A dose reduction may be required.

Infection with or without neutropenia: all patients should be advised to seek medical attention promptly at the first sign of infection.

Renal impairment: monitoring of renal function is advised in patients with renal impairment.

Thyroid disorders: optimal control of co-morbid conditions influencing thyroid function is recommended before start of treatment. Baseline and ongoing monitoring of thyroid function is recommended.

Tumour lysis syndrome: patients with high tumour burden prior to treatment should be monitored closely and appropriate precautions taken.

Allergic reactions: patients who had previous allergic reactions while treated with thalidomide should be monitored closely.

Severe skin reactions: REVLIMID® (lenalidomide) must be discontinued for exfoliative or bullous rash, or if SJS or TEN is suspected, and should not be resumed following discontinuation for these reactions. Interruption or discontinuation of lenalidomide should be considered for other forms of skin reaction depending on severity. Patients with a history of severe rash associated with thalidomide treatment should not receive lenalidomide.

Lactose intolerance: patients with rare hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Second primary malignancies (SPM): the risk of occurrence of hematologic SPM must be taken into account before initiating treatment with REVLIMID® (lenalidomide) either in combination with melphalan or immediately following high-dose melphalan and autologous stem cell transplant (ASCT). Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of SPM and institute treatment as indicated.

Hepatic disorders: dose adjustments should be made in patients with renal impairment. Monitoring of liver function is recommended, particularly when there is a history of or concurrent viral liver infection or when REVLIMID® (lenalidomide) is combined with medicinal products known to be associated with liver dysfunction.

Newly diagnosed multiple myeloma patients: patients should be carefully assessed for their ability to tolerate REVLIMID® (lenalidomide) in combination, with consideration to age, ISS stage III, ECOG PS≤2 or CLcr<60 mL/min.

Cataract: regular monitoring of visual ability is recommended.

Summary of the safety profile in multiple myeloma

Newly diagnosed multiple myeloma in patients treated with REVLIMID® (lenalidomide) in combination with low dose dexamethasone:

    The serious adverse reactions observed more frequently (≥5%) with REVLIMID® (lenalidomide) in combination with low dose dexamethasone (Rd and Rd18) than with melphalan, prednisone and thalidomide (MPT) were pneumonia (9.8%) and renal failure (including acute) (6.3%).
    The adverse reactions observed more frequently with Rd or Rd18 than MPT were: diarrhoea (45.5%), fatigue (32.8%), back pain (32.0%), asthenia (28.2%), insomnia (27.6%), rash (24.3%), decreased appetite (23.1%), cough (22.7%), pyrexia (21.4%), and muscle spasms (20.5%).

Newly diagnosed multiple myeloma patients treated with REVLIMID® (lenalidomide) in combination with melphalan and prednisone:

    The serious adverse reactions observed more frequently (≥5%) with melphalan prednisone, and REVLIMID® (lenalidomide) followed by REVLIMID® (lenalidomide) maintenance (MPR+R) or melphalan prednisone, and REVLIMID® (lenalidomide) followed by placebo (MPR+p) than melphalan, prednisone and placebo followed by placebo (MPp+p) were febrile neutropenia (6.0%) and anaemia (5.3%).
    The adverse reactions observed more frequently with MPR+R or MPR+p than MPp+p were: neutropenia (83.3%), anaemia (70.7%), thrombocytopenia (70.0%), leukopenia (38.8%), constipation (34.0%), diarrhoea (33.3%), rash (28.9%), pyrexia (27.0%), peripheral oedema (25.0%), cough (24.0%), decreased appetite (23.7%), and asthenia (22.0%).

Patients with multiple myeloma who have received at least one prior therapy:

    The most serious adverse reactions observed more frequently with REVLIMID® (lenalidomide) and dexamethasone than with placebo and dexamethasone in combination were venous thromboembolism (deep vein thrombosis, pulmonary embolism) and grade 4 neutropenia.
    The observed adverse reactions which occurred more frequently with REVLIMID® (lenalidomide) and dexamethasone than placebo and dexamethasone in pooled multiple myeloma clinical trials (MM-009 and MM-010) were fatigue (43.9%), neutropenia (42.2%), constipation (40.5%), diarrhoea (38.5%), muscle cramp (33.4%), anaemia (31.4%), thrombocytopenia (21.5%), and rash (21.2%).

Special populations

Paediatric population: REVLIMID® (lenalidomide) should not be used in children and adolescents from birth to less than 18 years.

Older people with newly diagnosed multiple myeloma: for patients older than 75 years of age treated with REVLIMID® (lenalidomide) in combination with dexamethasone, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle. No dose adjustment is proposed for patients older than 75 years who are treated with REVLIMID® (lenalidomide) in combination with melphalan and prednisone.

Older people with multiple myeloma who have received at least one prior therapy: care should be taken in dose selection and it would be prudent to monitor renal function.

Patients with renal impairment: care should be taken in dose selection and monitoring of renal function is advised. No dose adjustments are required for patients with mild renal impairment and multiple myeloma. Dose adjustments are recommended at the start of therapy and throughout treatment for patients with moderate or severe impaired renal function or end stage renal disease.

Patients with hepatic impairment: REVLIMID® (lenalidomide) has not formally been studied in patients with impaired hepatic function and there are no specific dose recommendations.

Please refer to the Summary of Product Characteristics for full European Prescribing Information.


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 next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.


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. Celgene undertakes 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’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.

All registered trademarks are owned by Celgene Corporation.


1 Palumbo A, et al. N Engl J Med. 2011;364:1046–1060.
2 Ferlay J, et al. Eur J Cancer. 2013;49:1374–1403
3 Moreau P, et al. Ann Oncol. 2013; 24 (Suppl 6): vi133-vi137
4 Moreau P, et al. Ann Oncol. 2013; 24 (Suppl 6): vi133-vi137
5 Stewart AK, et al. Blood. 2009;114:5436-5443.
6 Hoering A, et al. Blood. 2009;114:1299-1305
7 Bird JM, et al. Br J Haematol. 2011;154:32-75
8 Attal M, et al. Blood. 2006 Nov 15;108(10):3289-94
9 Child JA, et al. N Engl J Med. 2003; 348:1875-1883
10 McCarthy PL, et al. N Engl J Med. 2012;366(19):1770-1781. CALGB is the cooperative group Cancer and Leukemia Group B (now known as Alliance).
11 Attal M, et al. N Engl J Med. 2012;366(19):1782-1791. IFM is the cooperative group Intergroupe Francophone du Myélome.


Stacey Minton
Office: +41 32 729 62 36 / Cell: +41 79 265 23 52

Maryline Iva, +41 79 816 16 94
+41 32 729 8303

Permalink : http://www.me-newswire.net/news/3269/en

Pershing Square Holdings, Ltd. Provides Annual Investor Update Presentation

AMSTERDAM-Friday, January 27th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- Pershing Square Holdings, Ltd. (ticker: PSH:NA) posted today its Annual Investor Update Presentation on its website, https://www.pershingsquareholdings.com/company-reports/letters-to-shareholders/. The presentation includes a performance review, an update of the fund’s portfolio and an organizational update.

About Pershing Square Holdings, Ltd.

Pershing Square Holdings, Ltd. (PSH:NA) is an investment holding company structured as a closed end fund that makes concentrated investments principally in North American companies.


James Devas, +44 20 7379 5151

Permalink : http://me-newswire.net/news/3260/en

Sunday, January 29, 2017

IMA Chair-Elect in Middle East to Talk about Risks and Value Creation among Finance Professionals

Dubai, United Arab Emirates -Sunday, January 29th 2017 [ ME NewsWire ]

From January 28 to February 1, the Institute of Management Accountants (IMA) Chair Elect, Alex Eng, CMA, CFM, CPA, will visit four major cities in the Middle East to discuss the effects of fluctuating oil prices and how accounting and finance professionals can help create value for their organizations though their finance and business acumen.

During his 5-day tour, Eng will visit Dubai, Doha, Amman, and Cairo. In Dubai, Eng will be at Zayed University’s 3rd Annual Quantitative Research Symposium on January 28 to discuss the importance of an effective board in SMEs. Eng is also slated to meet selected CFOs in Dubai and Doha for a roundtable discussion on cost and cash flow management in turbulent times.

“Financial and management reporting and the increasingly competitive global environment puts pressure on CFOs to do the right things in the right ways and ensure our organizations are positioned to not only weather but thrive in these turbulent times,” states Eng.

CFOs from the region will hear from Eng’s experience as Vice President for US Corporate Finance at a public Fortune Global 100 Company and the world's largest power utility.

“Through these roundtable discussions, IMA helps CFOs explore practical action steps they can take to ensure that their organizations are positioned to thrive, not just survive, during this period of volatility and risks,” adds Eng.

The IMA has been instrumental in supporting the changing role of CFOs in today’s business environment. To recognize outstanding CFOs in the region, IMA will be at the CFO Middle East Awards on Sunday, January 29 at the Ritz Carlton Hotel in Jumeirah Beach Residence, Dubai.

IMA’s Chair-Elect will also be in Amman, Jordan and Cairo, Egypt to meet IMA partners and recognize new Certified Management Accountants (CMAs) in these two countries. The CMA® is IMA’s flagship certification program that helps accounting professionals prepare for progressive management accounting roles. For more information on the CMA certification, please visit: http://www.imanet.org/cma

About IMA® (Institute of Management Accountants)

IMA®, the association of accountants and financial professionals in business, is one of the largest and most respected associations focused exclusively on advancing the management accounting profession. Globally, IMA supports the profession through research, the CMA® (Certified Management Accountant) program, continuing education, networking and advocacy of the highest ethical business practices. IMA has a global network of more than 80,000 members in 140 countries and 300 professional and student chapters. Headquartered in Montvale, N.J., USA, IMA provides localized services through its four global regions: The Americas, Asia/Pacific, Europe, and Middle East/Africa. For more information about IMA, please visit www.imamiddleeast.org.


Janice Sevilla

+971 56 208 8948

Permalink : http://me-newswire.net/news/3267/en

Wilo Middle East Showcases latest German technologies at HVACR Expo Saudi, Jeddah

The Middle Eastern regional platform of the German company Wilo SE, gave customers an overview of its energy savings circulation pumps

Dubai, United Arab Emirates -Sunday, January 29th 2017 [ ME NewsWire ]

Wilo Middle East FZE, the leading pump manufacturer Headquartered in Germany, took part in the second edition of the HVACR Expo Saudi, the country’s largest dedicated air-handling and refrigeration event in the region. The expo, which was held at the Jeddah Centre for Forums and Events from 15-17 January 2017, presented a valuable networking opportunity for customers and the chance to view Wilo’s latest range of German technologies in HVAC (Heating, Ventilation and Air-conditioning) products.

The wide range of energy savings products showcased at the expo included include Yonos Pico, Stratos Pico, Stratos, Yonos Maxo; the energy-efficient hot-water heating systems, air-conditioning systems and closed cooling circuits. The newly enhanced pumps can now deliver to systems based on actual need thanks to the efficient "Q-Limit" operating mode, and boast a new and improved energy efficiency index of 0.20 or less.

Also on display at HVACR Expo Saudi is the Wilo-Split case pump, the Axially spilt case pump mounted on a baseplate, which pumps heating water in accordance with VDI  2035 water/glycol mixtures, cooling/cold water and domestic hot water applications in municipal water supply, irrigation, building services, general industry, power stations, etc.

Commenting on Wilo’s participation in the expo, Bishara Khalil – Managing Director, Wilo Middle East FZE said: “With 51 per cent market share across the GCC, Saudi Arabia is the world’s third largest market for Heating, Ventilation, Air Conditioning, and Refrigeration. With multi-billion dollar developments and mega projects in the pipeline; the demand for energy-efficient HVACR products, services, and technologies is set to double.”

For his part, Khaled Al Salama, Country Manager KSA, Wilo Middle East stated: “The HVACR Expo Saudi has been a significant opportunity for our existing clients and new potential customers with huge potential in the HVAC business to discover our latest ground-breaking products. Wilo, the leading and strongest industrial German brand in pumping systems, has long been known for its strong product portfolio. Building on our 144 years of experience, we will further endeavor to help decision makers in the HVAC sector in Saudi Arabia make the best use of our wide range of products to keep their business running smoothly with our highly efficient pumps.”

About Wilo Middle East

Wilo Middle East has had a presence in the Middle East for over 20 years through its local distributors. With growing markets in the building technologies sector and the introduction of high-efficiency pumps, customer requirements for technical support and services have become more urgent. This prompted Wilo SE to establish a direct presence in the region in 2006 by opening its first Middle East office at Techno Park, in Dubai.

In 2008, Wilo Middle East moved to Dubai’s Jebel Ali Free Zone, where it became the WILO SE Group's Headquarters for the entire Gulf region as well as Yemen. In November 2010, a new facility in south (JAFZA), Dubai was inaugurated to accommodate the company’s regional business expansion.  

Wilo SE in Germany

WILO SE is one of the world’s leading manufacturers of pumps and pump systems for building services, the entire water management chain and the industrial sector. The company, who achieved sales of more than 1.3 billion Euro last year, is heavily involved in research and development. The Dortmund-based company is progressively evolving from a components supplier to a system supplier. The Wilo name is internationally recognized as being synonymous with high-tech in the pump industry. The company owes its success to its workforce of around 7,400 employees in over 60 subsidiaries around the world.


Wilo Middle East

Fouad Ahmed, Marketing Manager


Email: fouad.ahmed@wilo.ae

Permalink : http://www.me-newswire.net/news/3264/en 

Julphar CEO Leaves the Company after 8 Years of Service

Ras Al Khaimah, United Arab Emirates -Sunday, January 29th 2017 [ ME NewsWire ]

Upon expiration of his contract – which comes in Q2 2017 – Dr Ayman Sahli, Chief Executive Officer of Julphar, has decided not to renew. The Board respects his wishes and has accepted his decision. Processes are underway to select his successor.

Commenting on Dr Ayman’s decision, His Highness Sheikh Faisal Bin Saqr Al Qasimi, Chairman of Julphar, said: "We appreciate Dr Ayman’s outstanding service for more than eight years. Despite the challenging market conditions, Dr Ayman made a major contribution to Julphar and the company has achieved significant performance improvements and profitability under his leadership. On behalf of the Board, I sincerely wish him well for the future."

"It has been a privilege to have had the opportunity to lead Julphar for the last decade and I am enormously proud of the accomplishments that have been made," said Dr Ayman Sahli. "The company has played such a positive role in my life. I am grateful for the support I have received from the Board of Directors and I express my heartfelt thanks to all employees for their dedication. I am confident that they will carry the company’s business forward to new heights."

About Julphar

Established in 1980, Julphar is the largest generic pharmaceutical manufacturer in Middle East and North Africa, producing over 200 branded products across its fifteen manufacturing facilities. Julphar’s mission is to offer high quality medicines at affordable prices, and its product portfolio includes: Wound, Anemia and Women Care, Adult Primary Care, Pediatric Primary Care, Gastro Care and Pain Management, Cardiopulmonary Care, and Consumer Care. In 2012 Julphar launched Julphar Diabetes, a 150 million-dollar Active Pharmaceutical Ingredient (API) manufacturing facility that has the capacity to produce 1,500 kg of recombinant human insulin and insulin analogues crystals (rDNA). Julphar employs approximately 3,000 people around the world and registered sales revenue of AED 1.47 billion in the year ending 2015. For more information, please visit http://www.julphar.net.


Mehtap Teke

Corporate Communication Manager

M +971-55-1934619, D +971-7-204-5209

Tel +971-7-246-1461, FAX +971-7-246-2462, mehtap.teke@julphar.net

Permalink : http://www.me-newswire.net/news/3266/en 

Saturday, January 28, 2017

HealthCare Royalty Partners Announces New Chief Medical Officer, Senior-Level Promotions, and Further Regional Expansion

STAMFORD, Conn. & SAN FRANCISCO & BOSTON-Saturday, January 28th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- HealthCare Royalty Partners ("HCR") today announced several firm developments:

New Chief Medical Officer:

As of January 2017, Dr. Warren Cooper has assumed the role of Managing Director and Chief Medical Officer at HCR. Dr. Cooper initially joined the team in 2016, consulting as an Industry Advisor. Dr. Cooper is a UK-trained physician with over 35 years of experience in the global pharmaceutical industry. HCR’s senior professionals have known Dr. Cooper for over a decade, working closely with him when he served as CEO of Prism Pharmaceuticals (“Prism”), a portfolio company at their prior firm. Prism was a specialty pharmaceutical company that developed the antiarrhythmic agent NEXTERONE, and was ultimately acquired by Baxter International in 2011 for $338 million. Prior to serving as CEO of Prism, Dr. Cooper spent 12 years with Merck, initially as a UK clinical research physician, then as head of European and subsequently Worldwide Clinical Research Operations. Dr. Cooper also previously led AstraMerck’s (now AstraZeneca PLC) cardiovascular division. HCR looks forward to drawing on Dr. Cooper’s tremendous clinical, regulatory and operational experience as it evaluates new investment opportunities.

Investment Professional Promotions:

HCR has promoted John Urquhart to a Principal of the firm. Mr. Urquhart was among the first employees at HCR, joining the firm as an analyst in 2007 and re-joining in 2012 after receiving his M.B.A. from The Wharton School of the University of Pennsylvania. Mr. Urquhart has over a decade of healthcare investing experience in the royalty and structured finance market.

HCR has also promoted Anthony Rapsomanikis to Vice President. Mr. Rapsomanikis joined HCR as an Associate in 2012, and was promoted to Director of West Coast Business Development after establishing the firm’s San Francisco office in 2015. The San Francisco office launched HCR’s strategic initiative to regionalize its business development efforts and better serve the needs of counterparties in key geographic areas.

“John and Tony’s promotions are well deserved and serve as recognition of their growth and contributions to the firm over the past several years,” commented Clarke Futch, co-founder and Chairman of the Investment Committee at HCR.

Regional Office Expansion:

HCR is pleased to announce its plans to open a Boston, MA office in the first half of 2017, which will be led by John Urquhart. Mr. Urquhart will work closely with Clarke Futch, Paul Hadden (Managing Director – Business Development) and the rest of the senior investment team, most of whom will continue to be based in the firm’s headquarters in Stamford, CT.

Paul Hadden commented, “The opening of our Boston office follows the success of HCR’s San Francisco office opening in 2015 and furthers our goal of strengthening local coverage and relationships in the key life science and R&D centers. Recent data shows that Boston and the San Francisco / Bay Area each garnered about one-third of all biotech venture capital investment in 2016 and it is important for us to continue to focus on these markets.”

About HealthCare Royalty Partners

HCR is a private investment firm that purchases royalties and uses debt-like structures to invest in commercial or near-commercial stage life science assets. HCR has $3.4 billion in cumulative capital commitments and is headquartered in Stamford, CT. Over the past decade, HCR's senior professionals have completed more than 60 healthcare investments. For more information, visit www.healthcareroyalty.com.


HealthCare Royalty Partners
Carlos Almodovar, 203-388-9085

Permalink : http://www.me-newswire.net/news/3263/en

Picasso Estate Sold to Scepter Chairman Rayo Withanage

MOUGINS, France-Saturday, January 28th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- The sprawling estate and final home of Pablo Picasso in Mougins, France was sold for an undisclosed sum to Brunei financier Rayo Withanage. The Mayor of Mougins confirmed in an official press release the sale as reported by The Wall Street Journal.

A resident of Bermuda and London, Mr. Withanage is the founder and chairman of Scepter Partners, a direct investment and merchant bank for sovereign investors. He is also a founder of The BMB Group alongside HH Prince Abdul Ali Yil Kabier of the Brunei Royal Family.

The high profile estate L’Antre du Minotaure (the Den of The Minotaur) is widely regarded as one of the finest properties in the south of France.

The property, which was recently lavishly refurbished under the direction of acclaimed architect Axel Vervoordt, covers over three hectares, with olive groves that are over 500 years old. The estate is the largest property of its kind in the area.

Picasso kept one of his most prolific studios in the main house, while living there with his wife Jacqueline and her daughter Cathérine. The house and the gardens were designed personally by Picasso and retain original art and furniture. Upon his death the property housed over $1 billion in art.

Prior to Picasso, the house was owned by the Guinness family and was famed for being a regular summer holiday home for Winston Churchill, who painted a number of works on the property. The origins of the house date back to an Abbey over a thousand years old and is presently adjacent to Notre-Dame-De-Vie which is one of the oldest churches in the region. The gardens are nationally acclaimed in France with some of the largest wisteria trees in Europe and a species of rose cultivated by Picasso himself that only grows on the property.

Under the new ownership, the property will be commissioned for charitable purposes by local foundations and the promotion of the arts through events from which proceeds shall be donated to causes supporting sustainable development initiatives headquartered in Monaco.

The property was most recently owned by Dutch real estate entrepreneur Tom Moeskops and BMB Alliance. The sale was part of a restructuring of the BMB Group which spun out its assets to form Scepter Partners, and was signed at the end of last year.

About Rayo Withanage

Rayo Withanage is the Founder & Executive Chairman of Scepter Partners. Trained as an M&A Lawyer with a masters from the London School of Economics, he spearheaded the development of the merchant banking and principal investment business of Scepter Partners which is a capital syndicate of family and sovereign investors. Scepter's senior management team spun out from the Blackstone Group under the leadership of Anthony Steains in 2015. Headquartered in Bermuda with offices in New York and Hong Kong, Scepter is supported by over $14 billion in discretionary assets and was founded to acquire large cap assets with a focus in natural resources, infrastructure, real estate and media and telecommunications. Mr. Withanage is of Sri Lankan and Portuguese decent. He was born in the Fiji Islands and grew up predominantly in Bermuda, New Zealand and Brunei.


Hill+Knowlton Strategies
Caleb Barnhart, 212-885-0310

Permalink : http://me-newswire.net/news/3262/en

Friday, January 27, 2017

TIM Brasil Confirms LTE Backhaul Network Deployment with SIAE MICROELETTRONICA

MILAN-Tuesday, January 24th 2017 [ ME NewsWire ]

(BUSINESS WIRE)-- TIM Brasil, a leading mobile operator in Brazil, awarded SIAE MICROELETTRONICA as supplier for the new mobile backhaul microwave radio network. This deployment is part of TIM new LTE network upgrade aiming to extend territory and population coverage. The signed frame contract covers supply of product and services for a three (3) years period.

TIM aimed to extend its existing mobile network by adding new LTE access sites favouring a larger coverage and service delivery capabilities toward its users. To interconnect the new sites to the existing wireless infrastructure TIM decided to rely on high capacity microwave radio, offering multi-gigabit connectivity and the flexibility needed to address deployment in an urban environment. TIM awarded SIAE MICROELETTRONICA that as part of the contract will supply its latest generations SM-OS based microwave and millimetre wave platforms including ALFOplus zero foot print solution, AGS-20 split-mount solution operating at frequencies from 6 to 38GHz up to 2048QAM and its ALFOplus80HD operating at 80GHz solution reaching over 2Gbps capacity. Along with the hardware SIAE MICROELETTRONICA will also provide all the related services from site survey, installation & commissioning for the regions of its competence.

“We are pleased of this award that sees our solution used to expand our previously deployed microwave infrastructure, as well as entering into a new network region,” says Luigi Lovati LATAM General Manager, adding, “This award, worth over 50% of the project, is a strong sign of recognition and confirmation of our ongoing relationship with TIM.”

“SIAE MICROELETTRONICA has been selected as key provider for supply equipment and services to support our large microwave roll-out, deploying the latest innovative technology to fulfil the requirements of LTE advanced backhaul network,” says Marco Di Costanzo, TIM Brasil Engineering Director.

To know more about TIM Brasil: www.tim.com.br


SIAE MICROELETTRONICA, founded in 1952, is a leader in wireless communication technology. Present in over 25 countries it offers to national and multinational operators advanced technological solutions in microwave and millimetre wave transport, services and design. With in-house advances RF capabilities from design to industrialization SIAE MICROELETTRONICA products bring innovation to the market satisfying the ever-changing market requirements and customers need.

For more information: www.siaemic.com or connect with us on LinkedIn.


Fabio Gavioli

Permalink : http://www.me-newswire.net/news/3240/en