Monday, February 28, 2022

Kapruvia® receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients

 ST. GALLEN, Switzerland & STAMFORD, Conn.-Monday 28 February 2022 [ AETOS Wire ]


Committee for Medicinal Products for Human Use (CHMP) recommends approval of Kapruvia®(difelikefalin) as first therapy in Europe for the treatment of chronic kidney disease associated-pruritus (CKD-aP) in hemodialysis patients

European Commission decision for EU Marketing Authorization is expected in Q2 2022

Kapruvia® is approved in the US under the trade name KORSUVA™ (difelikefalin) injection

ST. GALLEN, Switzerland & STAMFORD, Conn. --(BUSINESS WIRE) -- Regulatory News:

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of Kapruvia® (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients. The CHMP opinion is the basis for the European Commission’s final decision regarding marketing authorization for Kapruvia®. If approved, Kapruvia® will be the first therapy available in Europe for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients.

“The positive CHMP recommendation is another major step forward on our mission to help kidney patients around the world lead better, healthier lives,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “Kapruvia® has demonstrated important clinical benefits to significantly relieve patients of the severe burden of chronic kidney disease-associated pruritus, a condition that has been historically underdiagnosed and undertreated. We look forward to the European Commission decision anticipated in Q2 2022, and to bringing a therapy with the potential to advance treatment of CKD-aP to patients in Europe.”

“We are pleased to have received the positive CHMP opinion, which brings us one step closer to making a treatment option available to hemodialysis patients in Europe who suffer from pruritus,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “Together with our partner VFMCRP, we look forward to the European Commission decision in the second quarter of 2022 and to the commercial launch of KORSUVA™ (difelikefalin) injection in the United States in April 2022. These are major milestones on Cara Therapeutics’ path to being a category-defining leader in the treatment of pruritus.”

The positive CHMP opinion is based on pivotal clinical data from two phase-III trials, KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. These studies showed that treatment with Kapruvia® resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life components and was found to be generally well tolerated in patients with moderate-to-severe CKD-aP.

If approved, Kapruvia® would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and includes the companies: Vifor Pharma, Sanifit Therapeutics, and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit

About Cara Therapeutics

Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s novel KORSUVA™ (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin and plans to initiate Phase 3 programs in the first quarter of 2022 for the treatment of pruritus in patients with atopic dermatitis and non-dialysis-dependent chronic kidney disease. Phase 2 trials of oral difelikefalin are ongoing in primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus. For more information, visit and follow the company on Twitter, LinkedIn and Instagram.

About Chronic Kidney Disease-associated Pruritus (CKD-aP)

CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.1,2,3 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.4 CKD-aP is also an independent predictor of mortality and the risk for hospitalization among hemodialysis patients.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential regulatory approval of difelikefalin solution for injection and the potential timeline for EMA review and approval of the MAA and the potential of difelikefalin solution for injection to be a therapeutic option for CKD-aP in dialysis dependent patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Quarterly Report on Form 10-Q for the quarter ended 30 September 2021 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


1 Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505.

2 Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.

3 Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.

4 Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.

This press release features multimedia. View the full release here:


Contact and further information:

Media Relations

Nathalie Ponnier

Global Head Corporate Communications

+41 79 957 96 73

Investor Relations

Laurent de Weck

Investor Relations & Treasury Senior Manager

+41 58 851 80 95

Cara Therapeutics contacts:

Media Contact

Annie Spinetta

6 Degrees


Investor Contact

Iris Francesconi, PhD

Cara Therapeutics


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AIG’s Uplive ranked among fastest-growing apps globally

 Successes in the UAE and KSA, other emerging markets demonstrate AIG’s innovative global leadership in the live social industry

DUBAI, UNITED ARAB EMIRATES.-Monday 28 February 2022 [ AETOS Wire ]

Asia Innovations Group’s (AIG) flagship app Uplive has been ranked as the world’s third fastest-growing social app by third-party analytical platforms AppAnnie and Sensor Tower.

The global rankings, which come hot on the heels of the app’s unveiling of its first-ever Television Commercial for the Middle East region, which aired on Rotana, and a raft of GCC-centric features, exemplified AIG’s leadership in the global live social industry, and are results of AIG's continued focus to serve the emerging markets.

In 2021, AIG’s flagship live streaming app Uplive and dating apps Lamour and Cute U clinched top places in global app rankings based on downloads and consumer spending.

Uplive, the largest independent global video social entertainment platform, has consistently risen to become the top consumer spend app in APAC in 2021, according to App Annie. Uplive has also emerged as the fastest-growing live streaming app globally as measured by year-on-year growth in downloads, according to Sensor Tower.

Since the unveiling of the GCC-wide campaign, Uplive has attracted a large number of GCC-based live streamers, which has, in turn, boosted its Middle East subscriber base significantly with KSA and the UAE accounting for the lion’s share.

According to AIG, the leading live social company with 520 million registered users located in over 150 regions worldwide, Uplive’s growth in users was matched by significant revenue growth, where Uplive moved to the third fastest-growing Android app globally.

“We are pleased to be ranked as the third fastest-growing app in the world – an achievement that has been made possible by our ever-growing global fanbase. The app’s popularity is fully driven by the consumer-centric features and value it delivers to all its users. Through innovation, we have been able to design a value-driven platform that not only delivers real, customised entertainment to users but also provides a safe space for young entertainers to showcase their talents and earn while doing what they love,” said Andy Tian, chief executive officer, AIG.

“AIG is dedicated to providing an unbeatable user experience across our products, which our tremendous growth in 2021 reflects. We are proud of our leadership in the global app industry and our supremacy in emerging markets, including the GCC and the talent-rich UAE in particular. Our significant growth in 2021 is just the beginning; we look forward to introducing truly ground-breaking features in the upcoming year,” noted Andy.

The success of AIG products also reflects the global growth of the dating app and live streaming industries. App Annie reports that time spent on live-streaming apps increased by 900% since 2018, while time spent on dating apps increased by 95%. In the GCC alone, time spent on Uplive has significantly increased over the last few months signaling a growing appetite for Arabic content – an important demographic that had been underserved by other players.

As the foremost company producing live social products, AIG is strongly positioned as an industry leader in live streaming and dating apps. By placing a priority on emerging markets such as the Middle East and diversifying their offerings for local markets, AIG has tapped hitherto neglected but talent-rich markets to serve a truly global user base.

About Asia Innovations Group

Asia Innovations Group is a leading live social company with 520 million registered users located in over 150 regions worldwide. It has built a comprehensive and diverse portfolio as it seeks to achieve its mission of enriching people's lives worldwide through innovative and enjoyable live social products, which foster meaningful human connections. In addition to Uplive, which allows video social hosts to broadcast to the world, AIG owns CuteU and Lamour, the top dating app in global emerging markets. It includes operations in 18 offices around the globe that integrate local live social knowledge to foster individual market development and penetration. Focusing on major emerging markets, AIG leverages its track record of innovation, cutting-edge technology, a scalable global infrastructure, and global insights with local expertise to deliver user and shareholder value based on the most exciting growth opportunities in the live social marketplace.


Melwyn Abraham -

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Glucophage® Is the First Oral Diabetes Treatment Approved in Europe for Use During Pregnancy

 DARMSTADT, Germany-Monday 28 February 2022 [ AETOS Wire ]

  • In a European worksharing procedure (WSP), Glucophage® was approved as the first oral anti-diabetic medication to be used safely from conception to birth.
  • The approval was granted on the basis of Merck’s own safety cohort study CLUE1 and a large body of published evidence.
  • This approval addresses a significant unmet medical need as the prevalence of hyperglycemia during pregnancy is rising worldwide, currently at one in six births (21.1 million).2

(BUSINESS WIRE) -- Merck, a leading science and technology company, today announced in a European worksharing procedure (WSP) an extension to the label for metformin products in the EU - Glucophage® (metformin hydrochloride [HCL] immediate release), Glucophage XR® (metformin HCL extended release) and Stagid® (metformin embonate immediate release) - for use throughout pregnancy.

Maria Rivas, SVP and Chief Medical Officer at Merck said, “During pregnancy and when wanting to become pregnant, good glycemic control is of utmost importance, as insufficient glycemic control leads to a three times higher risk of pregnancy loss than in normoglycemic women. The estimated risk of malformation is doubled. Until now, pregnant women were required to use insulin to control their blood sugar during this period. The label extension now opens a tablet alternative to women who are not able or wanting to use daily injections.”

In a European worksharing procedure (WSP), the variation for label extension was approved based on results from Merck’s register-based cohort safety study, investigating the follow up of children from over ~4.000 pregnancies with metformin1 for up to 11 years and extensive independent scientific publications, which all confirmed no increased risk of congenital abnormalities or feto/neonatal toxicity after exposure to metformin at the time of conception and throughout pregnancy.

Pregnancy and diabetes

The prevalence of type 2 diabetes is rising around the world.2 In 2021, 21.1 million births worldwide (16.7%) were affected by hyperglycemia.In Europe, 3-7% of all pregnant women develop gestational diabetes (GDM).3,4 Furthermore, 1% of all pregnancies are in women with pre-existing type 2 diabetes.5 To date, these conditions had to be managed with insulin when drugs were needed. Regarding the periconceptional phase, insulin-resistant polycystic ovary syndrome (PCOS), which affects 5-20% of all reproductive-aged women6,7, is associated with a 15-fold increase in infertility. The rate of early pregnancy loss is three times greater in PCOS pregnancies.

Metformin during pregnancy

The European Health authorities participating in the WSP weighed the benefit and risk of metformin use on both the mother and child. Their decision was informed by data investigating metformin in pre-gestational and gestational diabetes. Regarding the mother, metformin was comparable to insulin in reaching maternal blood sugar control and was better than insulin regarding pregnancy weight gain.8,9,10 Metformin use during pregnancy was associated with a lower risk of pregnancy-induced hypertension and preeclampsia.9,11,12 When used together with insulin for pregestational diabetes, metformin significantly lessened the amount of insulin required and lowered the risk of severe hypoglycemia.13,14

As metformin crosses the placenta,15,16,17 the safety of the unborn child had to be confirmed: Children exposed to metformin in utero may be born lighter than those exposed to insulin but are less in danger of a risky blood sugar dip directly after birth. So far, no long-term risks for the child later in life (e.g. on mental development and weight) have been confirmed.1

Metformin alone may sometimes not be enough to control blood glucose. In these cases, it is recommended for doctors to use metformin in combination with insulin21 or change to insulin.



  1. Brand KMG, Saarelainen L, Sonajalg J, et al. Metformin in pregnancy and risk of adverse long-term outcomes: a register-based cohort study. BMJ Open Diab Res Care 2022;10:e002363
  2. IDF Diabetes Atlas, Tenth Edition 2021
  3. Behboudi-Gandevani S., Parajuli R., Vaismoradi M. A systematic review of the prevalence of gestational diabetes in Norway. [In Process] International Journal of Environmental Research and Public Health 2021 18:4 (1-12) Article Number 1423
  4. Wierzba W., Śliwczyński A., Karnafel W., Bojar I., Pinkas J. Gestational diabetes mellitus/hyperglycaemia during pregnancy in Poland in the years 2010-2012 based on the data from the National Health Fund. Ginekologia polska 2017 88:5 (244-248)
  5. Shub A., Lappas M.: Pregestational diabetes in pregnancy: Complications, management, surveillance, and mechanisms of disease—A review. Prenatal Diagnosis 2020 40:9 (1092-1098)
  6. National Health Statistics Reports Number 86, May 20, 2015.
  7. McDonnell, Women’s Health 2017, Vol. 13(3) 89–97
  8. Tarry-Adkins PLoS Med 2020, 17(5): e1003126
  9. Guo, Journal of Diabetes Research 2019 Article Number 9804708
  10. Butalia Diabetic Medicine 2017 34:1 (27-36)
  11. Mateus Journal of Obstetrics and Gynecology 2020 222:1 Supplement (S691- S692)
  12. Cluver BMJ 2021;374:n2103
  13. Tarry-Adkins PLoS Med 2020, 17(5): e1003126
  14. Feig The Lancet Diabetes and Endocrinology 2020 8:10 (834-844)
  15. Charles Ther Drug Monit 28:67–72
  16. de Oliveira Baraldi. Clin Pharmacokinet 2012;51:743-9
  17. Ahmadimoghaddam Reprod Toxicol 2013;39:17-22
  18. Lee: DIABETICMedicine 2020. DOI: 10.1111/dme.14250
  19. Freinkel: Banting Lecture 1980: Of pregnancy and Progeny. Diabetes 1980: 1023- 35X
  20. Latif British Journal of Diabetes and Vascular Disease 2013 13:4 (178-182)
  21. Rowan New England Journal of Medicine 2008 358:19 (2003-2015)

About Glucophage®

Glucophage® (metformin hydrochloride) is a prescription-only medicine indicated for the treatment of type 2 diabetes mellitus, particularly when dietary management and exercise alone does not result in adequate glycaemic control. In adults, Glucophage® may be used as monotherapy or in combination with other oral anti-diabetic agents or with insulin. In children from 10 years old and adolescents, Glucophage® may be used as monotherapy or in combination with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with Glucophage® as first-line therapy after diet failure. The most commonly reported side effects with Glucophage® are gastro-intestinal disturbances that may occur during treatment initiation and resolve spontaneously in most cases. The Glucophage® product portfolio comprises: Glucophage® IR (immediate release) and Glucophage® XR (extended release) and Stagid® (metformin embonate immediate release).

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to to register online, change your selection or discontinue this service.

View source version on

Phone: +49 151 145 497 87

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Interim Phase 4 Data Support TAKHZYRO® (lanadelumab) as an Effective Treatment to Reduce Attacks in Hereditary Angioedema Patients

 OSAKA, Japan & CAMBRIDGE, Mass.-Monday 28 February 2022 [ AETOS Wire ]

− Interim Real-World Data from Phase 4 EMPOWER Study Show Attack Rate Reduction and Improvement in Treatment Satisfaction and Other Patient-Reported Outcome Scores1

− Interim Patient-Reported Outcomes Showed a Reduction of Monthly Attack Rates in New Users and Showed Sustained Angioedema Control in Established Users Over Twelve-Months Using the Angioedema Control Test (AECT)1,2,3

− Attack Rate Reduction in Patients Previously on Androgen Treatments Consistent with Study Population in Phase 3 HELP OLE Based on Post-Hoc Analysis4

(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) today presented four abstracts including interim real-world data from the observational Phase 4 EMPOWER study of TAKHZYRO® (lanadelumab) as a treatment for people with Hereditary Angioedema (HAE) Type I or II in North America, as well as findings from a post-hoc analysis of the HELP Open Label Extension study of long-term safety and efficacy of TAKHZYRO in HAE patients 12 years of age and older at the American Academy of Allergy, Asthma and Immunology (AAAAI) 78th Annual Meeting.

“A big challenge for HAE patients is the unpredictability of attacks and the impact that the attacks have on quality of life. We are encouraged by the initial results of the EMPOWER study, along with the additional evidence presented in the HELP Open Label Extension,” said Associate Professor Paula Busse, MD, Division of Allergy and Clinical Immunology, Icahn School of Medicine at Mount Sinai in New York, NY USA. “Data from both studies show that lanadelumab had marked reduction in attack rates, and that angioedema control was sustained for 12 months.”

Key findings from the data presentations include:

Improvements among new users and sustained outcomes in established users were reported in scores of the Angioedema Quality of Life Questionnaire (AE-QOL), Angioedema Control Test (AECT), and the Treatment Satisfaction Questionnaire for Medication (TSQM-9) when collected every three months, as presented in the EMPOWER IA2 Patient-Reported Outcomes interim data presentation.1

An average of 1 in 5 established TAKHZYRO users were able to extend treatment from every 2 weeks to 4 weeks as shown in interim data shared in the EMPOWER IA2 Treatment Patterns and Subgroups presentation.3

Interim real-world data showed marked attack rate reduction of 83% and no new safety signals based on patient self-reporting reduced attack rates in the EMPOWER IA2 Effectiveness and Safety presentation.2

A post-hoc analysis of HELP and HELP OLE showed that reduction of attack rates with TAKHZYRO were similar for patients previously on androgen treatments as they were for the wider treatment population in these studies in the Switch from Androgens to TAKHZYRO in HELP 03 and HELP 04.4

“We are pleased to see the real-world data from EMPOWER show improvements in angioedema control and treatment satisfaction. These interim results provide a better understanding of the overall patient experience with TAKHZYRO," said Neil Inhaber, MD, Head, Rare Genetics and Hematology, Global Medical Affairs, Takeda. “With more than a decade of experience and innovation for patients with this devastating condition, Takeda remains committed to continuing our unwavering support for the HAE community.”

The observational Phase 4 EMPOWER study, evaluating real-world HAE attack rates before and after treatment with TAKHZYRO in patients with HAE types I and II, is ongoing. Full results of the EMPOWER study are expected to be published in 2024. HELP OLE is a completed Phase 3 study of the safety and efficacy of TAKHZYRO in patients previously treated with androgens and other therapies for long-term prophylaxis prior to transitioning to TAKHZYRO.

About Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.5,6,7 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.7,8 HAE affects an estimated 1 in 50,000 people worldwide. It is often under recognized, under diagnosed and under treated.5,7,8

Takeda in Hereditary Angioedema

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them.

About TAKHZYRO® (lanadelumab-flyo) Injection

TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 12 years and older. It was studied in one of the largest prevention studies in HAE with the longest active treatment duration, and TAKHZYRO consistently demonstrated HAE attack reduction. TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks. TAKHZYRO is intended for self-administration or administration by a caregiver once trained by a healthcare professional.9

TAKHZYRO Safety Information for Europe

Please consult the TAKHZYRO Summary Product Characteristics (SmPC) before prescribing.

TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.9


Hypersensitivity to the active substance or to any of the excipients.9

Warnings and Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.9

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.9

General: TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication. There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.9

Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in international normalised ratio (INR) between treatment groups.9

Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.9


No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.9

As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor.9


Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies.9

The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.9


The most commonly observed adverse reaction (52.4%) associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.9

Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%)

Very common

(frequency ≥1/10):

Injection site reactions*


(≥1/100 to <1/10):

Hypersensitivity**, dizziness, rash maclo-papular, myalgia, alanine aminotransferase increased, aspartate aminotransferase increased.

*Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.

** Hypersensitivity includes: pruritus, discomfort and tingling of tongue.

For European Union Summary of Product Characteristics, please visit

For full U.S. Prescribing Information, including the approved indication and important safety information, please visit

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit

On February 28, Rare Disease Day 2022, as part of our commitment to individuals living with rare diseases, Takeda is joining patient organizations across the globe to support the worldwide call to action to ensure equity and understanding for every member of the rare disease community.

Paula Busse, MD received compensation for grant funding and consulting fees for Takeda.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

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EMPOWER IA2 patient-reported outcomes: Impact of lanadelumab on patient-reported outcomes in hereditary angioedema in the US and Canada: Interim findings from the EMPOWER Study. AAAAI 2022.

EMPOWER IA2 effectiveness and safety: Long-term effectiveness and safety of lanadelumab in the US and Canada: Findings from the EMPOWER Study. AAAAI 2022.

EMPOWER IA2 treatment patterns and subgroups: Treatment patterns among patients with HAE-C1-INH: Interim analysis findings from US and Canada participants in the EMPOWER study. AAAAI 2022.

Switch from androgens to Takhzyro in HELP 03 and HELP 04: Lanadelumab efficacy and safety after switching from androgens: Analysis of the phase 3 HELP and HELP OLE studies for hereditary angioedema. AAAAI 2022.

Cicardi M, Bork K, Caballero T, et al; on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.

Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.

Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.

Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.

TAKHZYRO® (lanadelumab) European Summary of Product Characteristics.

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Ryoko Matsumoto

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Radisys Showcases Open Telecom and Digital Engagement Innovations at #MWC22

Operating at the intersection of three key factors – Disaggregation, Broadband-Everywhere and Advanced Monetization

HILLSBORO, Ore.-Monday 28 February 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- Radisys® Corporation, a global leader of open telecom solutions, today announced a showcase of its end-to-end open telecom and digital engagement portfolio at MWC Barcelona 2022 in Booth 5B81. Following the successful disaggregation of the flagship Media Server which is currently operating in over 200 networks, Radisys is extending the principles of disaggregation across both fixed and mobile broadband access offerings. Radisys’ Software-centric Network Functions, complemented by Open Hardware components, are now ready for operators to deploy to begin accruing the benefits of modern network architectures. Complementing these offerings, the focus on monetization leverages the power of computing-at-the-edge and offers new revenue opportunities.

Disaggregation of 5G and FTTX Access Networks

Radisys will demonstrate 5GNR solutions enabled with its Release 16 compliant 5G software and systems integration capabilities. Attendees will learn how Radisys with its ecosystem partners is enabling a diverse customer base in the 5G space for CSPs, private networks and other market verticals. The 5G Innovation Showcase will include a 5G Small Cell demonstration with highly optimized architecture and low footprint and a network-in-a-box demonstration with 5G vRAN protocol software.

Radisys will demonstrate its open, disaggregated, cloud native PON solution with the flexibility and scalability to transform FTTX networks. Attendees will see triple-play services over XGS-PON with Radisys’ Combo PON OLTs (simultaneous G-PON and XGS-PON support).

Radisys is actively participating in the SD-RAN and VOLTHA demonstrations with ONF. Meet Radisys at the ONF Pavilion Hall 1 (Booth 1F66).


Radisys will demonstrate the realization of true, converged broadband-everywhere networks powered by software-defined, disaggregated, Open RAN leveraging FTTX-based xHaul transport supported by automation, analytics monetization, and guaranteed assurance of service.

Radisys will showcase its complete network lifecycle services – consult, design, build, integrate, operate, and optimize – across all of the network domains of today’s digital networks including the RAN, Optical/IP Transport, Core and Enterprise networks.


Radisys’ Smart Living Demonstration is made possible by Radisys’ Reach Smart Home that enables broadband service providers to increase customer stickiness and revenue by bundling smart home services with broadband plans. Use cases include comfort living, home security, safety and energy management. Radisys’ Smart Home Operator Dashboard brings insightful business KPIs for monetizing new services.

Radisys’ Digital Engagement showcase will highlight the video analytics capabilities of its Engage Platform, including mask detection and social distancing. Service providers can use these analytics to build specific applications such as biometric authentication and COVID policy enforcement.

Attendees will have a personalized interaction with Radisys’ Engage Video Assistant (EVA) – the world’s first three-in-one AI-based video bot.

Radisys will feature its newly launched Engage Digital Platform (EDP), a flexible, reliable and low code/no code Communications Platform-as-a-Service (CPaaS). Radisys will demonstrate the ease of use of the EDP Portal where admins and developers can create new services almost instantaneously via a drag and drop menu.

Leadership Presence

Radisys and global service providers Deutsche Telekom and Reliance Jio will share their joint vision on disaggregated access during an interactive panel discussion taking place Tuesday, March 1 at 15:10-15:25 CET on the DT booth stage, Booth 3M31.

Radisys is sponsoring the Open RAN Summit at MWC. Ganesh Shenbagaraman, head of integrated products and ecosystems, will participate on a panel discussion on “Open RAN Opportunity Use Cases” on March 2 from 2:30pm-3:30pm in CC3.13 Fira Gran Via.

Radisys’ head of Mobility Software and Services, Munish Chhabra will participate in Xilinx’s 5G Leadership Power Hour Theater Session on March 2 from 9:30am-11:00am at the CET Theater 2 in Hall 7.

“Our theme for MWC is ‘Connectivity Reimagined, Experience Reimagined, Telco Reimagined’ and we are showing service provider and enterprise customers how our solutions can aid their network and business transformation with open platforms and architectures, and new innovative services and digital engagement solutions to reimagine their role as true digital engagement providers,” said Natasha Tamaskar, head of Global Marketing, Business Strategy and Digital Endpoints Business, Radisys. “Unlike other modern OEMs in the market, Radisys has a unique position as our portfolio covers both fixed and mobile access and leverages the global footprint of our media platform complemented by digital endpoints and services. Our solutions enable greater service opportunities and enhanced digital experiences for customers across the globe.”

To meet with Radisys’ experts at MWC Barcelona and learn more about innovations in Open RAN, broadband, and digital engagement, contact

About Radisys

Radisys, a global leader in open telecom solutions, enables service providers to drive disruption with new open architecture business models. Radisys’ innovative disaggregated and virtualized enabling technology solutions leverage open reference architectures and standards, combined with open software and hardware to power business transformation for the telecom industry, while its world-class services organization delivers systems integration expertise necessary to solve communications’ and content providers’ complex deployment challenges. For more information, visit

Radisys® is a registered trademark of Radisys. All other trademarks are the property of their respective owners.

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Nereus for Radisys

Lori Zielinski, +1-503-459-9150

Japanese Local 5G Player Hytec Inter Selects Radisys RAN Software

 Hytec Inter’s 4K LLC platform integrated with Radisys’ Connect RAN software delivers an on-premises solution for Local 5G deployments by customers in Japan and around the world

HILLSBORO, Ore-Monday 28 February 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- Radisys® Corporation, a global leader of open telecom solutions, today announced that Japanese 5G player Hytec Inter is leveraging Radisys' Connect RAN software to enable its local 5G solution for private networks. Radisys’ 3GPP-compliant Connect RAN 5G solution enables an elastic and agile 5G network tailored to meet the unique requirements of diverse 5G applications with minimized CAPEX, improved time-to-market, and shortened time-to-revenue. Hytec Inter distributes 4.9 GHz long distance wireless access systems, private LTE (local 4G), and develops 4K video encoding/decoding, ultra-Low Latency narrowband video transmission systems and local 5G solutions.

News Highlights

Radisys and Hytec Inter have developed a local 5G platform solution that enables rapid optimization for high resolution video for AI/DX (digital transformation) applications, geared towards small and medium-sized deployments and adaptable for on-premises configurations.

Radisys’ industry-leading, feature-rich Connect RAN Software coupled with Hytec Inter’s 4K LLC, an ultra-low latency 4K video platform with a proprietary bandwidth management system, is optimized for 5G uplink transmission and promises significantly reduced time-to-market for customers.

Radisys’ Connect RAN 5G Software is compliant with specifications from 3GPP, the Small Cell Forum, and the O-RAN Alliance, and it won the Small Cell Forum award for Outstanding Contribution to Small Cell Open RAN Platforms. The software is available pre-integrated and pre-validated on multiple industry-leading platforms to accelerate global 5G deployments.

“We are excited to partner with Hytec Inter to deliver an innovative solution for Japan's local 5G market deployments,” said Munish Chhabra, SVP and General Manager, Software and Services, Radisys. “Our multi-platform software will deliver the performance and latency requirements required by Hytec Inter’s customers that want to deploy their own 5G private network.”

“There is a huge opportunity for private wireless network solutions and we value this partnership with Radisys to bring local 5G to our customers,” said Norihito Asao, President and CEO, Hytec Inter. “Radisys is an industry leader in 5G software and its 3GPP compliant solution integrated with the Hytec 4K LLC will enable us to deliver exciting new applications for digital transformation. In particular, the ability to jointly deliver an on-premise configuration that allows our customers to have their own complete 5G network and allows us to offer a differentiated solution that supports our customers’ goals for latency, performance and control over their network.”

About Radisys

Radisys is a global leader in open telecom solutions and services. Its disaggregated platforms and integration services leverage open reference architectures and standards combined with open software and hardware, enabling service providers to drive open digital transformation. Radisys offers an end-to-end solutions portfolio from digital end points to disaggregated and open access and core solutions, to immersive digital applications and engagement platforms. Its world-class and experienced network services organization delivers full lifecycle services to help service providers build and operate highly scalable and high-performance networks at optimum total cost of ownership. For more information, visit

About Hytec Inter

Hytec Inter is an industry leading distributor and developer of communications and networking equipment in Japan. Supported by a highly experienced world class technical engineering team, Hytec delivers and provides full lifecycle support for premium end-to-end solutions in government, defence and industrial market sectors. Its 4K video solutions reliably and securely deliver low latency high quality video over challenging narrowband networks. Combined with providing secure and scalable high performance private 5G networks in demanding on-premise applications. For more information, visit

Radisys® is a registered trademark of Radisys. All other trademarks are the property of their respective owners.

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Nereus for Radisys

Lori Zielinski, +1-503-459-9150

Oral-B® Brings a New Reality to Oral Care With Ground-breaking AI Integrated Device at Mobile World Congress 2022

 BARCELONA, Spain-Monday 28 February 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- As Artificial Intelligence makes its way into almost every facet of life, it makes sense that our oral health routine gets a smart upgrade too. Today, at Mobile World Congress Barcelona, Oral-B® the #1 Dentist Recommended Brand Worldwide and leader in oscillating-rotating electric toothbrushes, announces its latest technological innovation: Oral-B iO™ 10 with iOSense™.

The new iO10 with iOSense, the latest addition to the revolutionary iO range, is set to revolutionise the way we brush our teeth with a personalised experience like never before.

It is accompanied by a smart device called iOSense, which offers real-time guidance with the aid of AI and a personalized brushing experience that ensures healthier gums and teeth.

Benjamin Binot, P&G Europe Oral Care Senior Vice President says; “The innovation represents a new era of brushing that is more than just an electric toothbrush – it’s a fusion of ground-breaking technology, desirable design and amazing performance. iO 10 with iOSense is our latest commitment to building a digital health ecosystem that leads with advanced technologies, accessible solutions and more effective educational tools to improve oral care and health for all.”

“Our clinical tests show that Oral-B® iO delivers a deeper clean of teeth and gums versus a manual toothbrush, but now with iOSense, the personalized brushing experience will revolutionize our entire relationship with our oral health,” says Maike Siemons, Europe R&D Oral Care leader.

Artificially Intelligent:

The NEW iOSense device is powered by artificial intelligence to intuitively guide your brushing and provide a personalized brushing experience like no other. It guides you…

When to brush: the iOSense has a timer for optimal brushing time and a Wi-Fi clock

Where to brush: the intuitive iOSense lights mean you’ll never miss a spot

How to brush: the Oral-B® App tracks your goals and provides personalizes feedback after every brushing

The iOSense is also a magnetic charger that charges your brush in about 3 hours. For users on-the-go, it comes with the Power2Go charging travel case, meaning you can charge at your leisure.

Smart Performance:

Oral-B® iO’s revolutionary micro-vibration technology removes 100% more plaque than a manual brush to give you that professional clean feeling, at home, improving your oral health and contributing to better overall body health​. However, it’s not only about what the iO can do, it’s also about how it makes you feel. Using iO10 is a truly sensorial experience that will transform the act of brushing into something you have to do into something you want to do.

In clinical tests, Oral-B® iO provided a deeper clean of teeth and gums, allowing users to maintain oral health easily and effectively. Versus manual toothbrushes, Oral-B iO users experienced:

Six times more plaque removal along the gumline

100% healthier gums in one week

Whiter teeth in one week thanks to revolutionary iO™ technology

In a 6-month clinical study:

96% of patients using Oral-B® iO moved from non-healthy to healthy gums meaning the longer you use iO, the better off you are.

By using Oral-B® iO, users have 14.5x higher odds of moving from non-healthy gums to healthy gums compared to a regular manual toothbrush.

Oral-B® iO removes 62% more plaque than Sonicare DiamondClean SMART along the gumline and 26% more plaque in hard-to-reach areas.

The Oral-B® iO 10 Design:

Comes in two new galactic-inspired brush designs, cosmic black and stardust white.

The interactive Colour Display enables easy navigation through the brush features including welcome greetings, language settings and selection of cleaning modes, including sensitive, deep clean and whitening.

The Smart Pressure Sensor guides users to apply optimal cleaning pressure. The sensor warns of overpressure with a red light and indicates in green when users are applying the optimal cleaning pressure, maximising the effectiveness of Oral-B® iO’s iconic round brush head, inspired by dentist tools.

The Oral-B® app provides personalized feedback after every brushing session. It enables easy navigation through the brush features and allows a simple set-up of the brushing system. It also allows you to customize your brushing experience within the app, by setting up personal goals to meet your individual needs.

The Oral-B® app also provides 3D graphics and the AI Brushing technology recognizes all areas within the mouth, guiding users toward 100% brushing area completion.

The Visual Timer provides personalized guidance for users to reach their best clean yet. The timer tracks each brushing sessions duration, so users know when they have brushed for the dentist-recommended two minutes. Smiley icons on the display let users know if they have achieved their goal.

Democratizing Oral-B® iO: Introducing Oral-B iO4 and iO5

At MWC 2022 Oral-B® is also launching iO™ Series 4 and 5, affordable alternatives that still have the innovative iO™ technology, meaning a superior brushing experience is available for all, whatever your budget.

Comes in a range of new colours: Quite White, Matt Black and Blush Pink or Lavender

Powered by artificial intelligence

Has an intuitive smart pressure sensor that coaches you in real-time

Dentist-inspired round brush head with unique micro-vibrating bristles

Comes with smart modes so you can personalise your clean

Healthy Habits for People and the Planet

This year at MWC 2022, Oral-B will highlight its commitment to powering the smallest daily habits, such as using an electric toothbrush, to create a positive impact on the health of your whole body, whole family and the whole planet. Healthy habits for the environment mean a world where everyone respects our planet and its natural resources by:

Turning off the tap when brushing your teeth

Recycling packaging and products

Unplugging the toothbrush charger when not in use

About Oral-B

Oral-B® exists to help people Brush Like a Pro. Oral-B® was founded in 1950 by a California periodontist, who invented an innovative toothbrush to help his patients achieve healthier teeth and gums at home. Oral-B® continues to stay true to his mission and is today the worldwide leader in the over $5 billion brushing market. Part of the Procter & Gamble Company, the brand manufactures electric toothbrushes and toothpaste for adults and children, oral irrigators, and interdental products.

About Procter & Gamble

P&G serves consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Febreze®, Gillette®, Head & Shoulders®, Lenor®, Olay®, Oral-B®, Pampers®, Pantene®, SK-II®, Tide®, Vicks®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit for the latest news and information about P&G and its brands.

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Esten Peirce

Mavenir Showcases End-to-End 5G Core Including IMS and Automation Hosted on AWS

BARCELONA, Spain-Monday 28 February 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- Mavenir, a network software provider building the future of networks with cloud-native software that transforms the way the world connects, announced today that it will be showcasing Amazon Web Services’ (AWS) cloud-hosted 5G core network for various 4G/5G use cases at Mobile World Congress 2022. Mavenir is already working with customers for trials and deployment of Mavenir’s end-to-end solution on AWS.

Mavenir will deploy the cloud-native packet core, IMS, voice, messaging, and orchestration components hosted on AWS. The solution will use Mavenir’s Digital Enablement platform as a front end for overall service management, providing customers with an interface for self-service management. The pilot is focused on the ease of placing a network order through the self-service interface, leading to the deployment on AWS. This includes the chaining of multiple network layers, deployment actions, and configuration of network functions, thus reducing the overall service design and deployment times.

This Mavenir pilot for cloud-based services rollout and management for Communication Service Providers (CSPs) paves the way for automated deployment using pre-integrated and end-to-end validated solutions on AWS. It showcases reduced time for setup and integration and a low cost of ownership for rapid service trials and rollouts. The solution targets CSPs looking to take advantage of public cloud technology with reliable, carrier-grade, high-performance solutions with security and on-demand scaling. The solution is flexible, and operators will be able to pick and choose among the available solution components and enhance it with optional integration with on-premise workloads per their needs. Mavenir is also offering advance features and capabilities like network slicing as part of the service.

“As part of Mavenir's strategic focus on public cloud readiness for telcos, building this relationship is a step towards lowering Total Cost of Ownership (TCO) and speed up rollouts. The public cloud-based network solution, consumed as a service, brings in desired time to market, responsiveness, flexibility, and features like slicing will allow operators to extend their offering to industries and enterprises," said Bejoy Pankajakshan, Chief Technology and Strategy Officer at Mavenir.

“Many of our telco customers are eager to leverage the power of cloud to optimize service rollout and management, and to modernize their operating models as the current approaches make it time-consuming and expensive to design, scale, and manage their networks,” said Jan Hofmeyr, Vice President, EC2 Edge at AWS. “With this, AWS and Mavenir are making it simple, quick, and less expensive to set up telco networks at scale using pre-integrated solutions.”

About Mavenir:

Mavenir is building the future of networks and pioneering advanced technology, focusing on the vision of a single, software-based automated network that runs on any cloud. As the industry's only end-to-end, cloud-native network software provider, Mavenir is focused on transforming the way the world connects, accelerating software network transformation for 250+ Communications Service Providers in over 120 countries, which serve more than 50% of the world’s subscribers.

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Mavenir PR Contacts:

Maryvonne Tubb (US)

Emmanuela Spiteri (EMEA)

New MAVENCLAD® Data at ACTRIMS Forum 2022 Show Favourable Efficacy Outcomes Versus Other Oral DMTs and Lower Occurrence of Further Relapses or Disability Progression


DARMSTADT, Germany-Thursday 24 February 2022 [ AETOS Wire ]

    New real-world data show MAVENCLAD® (cladribine tablets) had lower annualised relapse rates and longer time to first relapse and time to switch than fingolimod, dimethyl fumarate and teriflunomide in relapsing multiple sclerosis patients
    Additional clinical trial data show patients treated with MAVENCLAD early after a first clinical demyelinating event had a lower occurrence of further relapses or disability progression as compared to placebo

Not intended for UK and U.S. based media

(BUSINESS WIRE) -- Merck, a leading science and technology company, today announced new real-world data from the MSBase Registry demonstrating MAVENCLAD® (cladribine tablets) had more favourable relapse outcomes and longer time to switch to another disease modifying therapy (DMT) compared to the oral DMTs fingolimod, dimethyl fumarate (DMF) and teriflunomide in relapsing multiple sclerosis (RMS) patients. A second study, analysing real-world follow up of clinical trial patients with a first attack suggestive of MS, showed those treated with MAVENCLAD had a lower rate of conversion to clinically definite multiple sclerosis (CDMS), defined by further relapse or disability progression, and lower risk of relapse than those not exposed to MAVENCLAD. These data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, taking place 24-26 February 2022.

In this first analysis of its size from the Generating Learnings In MultiPle SclErosis (GLIMPSE) study, data from 633 patients prescribed MAVENCLAD in the MSBase Registry was matched using propensity scores to patients receiving fingolimod (n=1195), DMF (n=912) or teriflunomide (n=735). Results showed the annualised relapse rate (ARR) for patients treated with MAVENCLAD was 0.09 compared to 0.15, 0.15 and 0.17 for fingolimod, DMF and teriflunomide, respectively. Time-to-first relapse in MAVENCLAD-treated patients was 40%, 42% and 67% lower than in patients treated with fingolimod, DMF and teriflunomide, respectively. The time to switch rate in patients treated with MAVENCLAD was 4, 7 and 6.5 times lower than fingolimod, DMF and teriflunomide, respectively. The GLIMPSE study was a longitudinal, retrospective analysis of adult patients identified with RMS from the MSBase Registry, an international online registry for neurologists studying MS and other neuro-immunological diseases.

“It is important in a lifelong disease like MS to continue assessing the efficacy and safety of available treatment options in the real world,” said Helmut Butzkueven, MBBS, FRACP, PhD, Department of Neuroscience, Central Clinical School, Monash University, Melbourne. “This is where the MSBase Registry, using standardised data records from over 79,000 people with MS around the world, can provide information that is not possible to obtain in a randomised clinical trial. This information showed us that in GLIMPSE, MAVENCLAD had better relapse outcomes and longer treatment persistence compared to other oral DMTs, including fingolimod.”

Also being presented are new data from an exploratory Phase IV CLASSIC-MS follow-up of patients (n=227) from the Phase III ORACLE-MS study which suggest early use of cladribine tablets reduced the risk of further relapse or disability progression (CDMS) in patients who experienced a first episode of neurologic attack with characteristics that put them at high risk of CDMS. Over half the patients (53.2%) treated with cladribine tablets remained relapse free compared to 28.2% of those who did not receive cladribine tablets. In patients who received cladribine tablets, 42.9% were diagnosed with CDMS in the median of 9.5 years since their last dose. In patients never treated with cladribine tablets, 70.4% were diagnosed with CDMS.

In ORACLE-MS, patients with a first clinical demyelinating event were randomised to receive cladribine tablets 3.5 mg/kg, cladribine tablets 5.25 mg/kg or placebo. This analysis at the ACTRIMS Forum 2022 investigated the long-term efficacy in patients from the ORACLE-MS trial who had received at least one course of cladribine tablets (68.7%) or placebo (31.3%). Cladribine tablets (5.25 mg/kg) are not approved for any use in any region.


MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in over 80 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details.

The clinical development programme for cladribine tablets includes:

    The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.

    The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.

    The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).

    The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.

    PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.8 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck`s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have the potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE).

All Merck Press Releases are distributed by email at the same time they become available on the Merck Website. Please go to to register online, change your selection or discontinue this service.

About Merck
Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Electronics.

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Geoffrey Vokes
+31 6 51 42 10 99

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NielsenIQ: 60% of Product Relaunches Don't Pay Off


CHICAGO -Friday 11 February 2022 [ AETOS Wire ]

NielsenIQ BASES introduces a new product to help brands stay relevant.
BASES Renovator is a groundbreaking solution that helps brands stay ahead of their competition.

(BUSINESS WIRE)-- Around the globe, more than 230k new products are launched yearly, however, only 8% of consumers are committed to their current brand, according to NielsenIQ’s research. To stay relevant in this constantly evolving competitive environment, brands need to adapt or risk losing market share. However, if brands wait too long to evolve, it may be too late.

NielsenIQ is constantly innovating its product offerings to provide clients with actionable insights that allow them to make efficient, informed decisions. We know that 60% of relaunches do not recover from their downward trend, thus we developed a new, groundbreaking solution that will provide brands comprehensive analytics and faster insights to help them adapt their existing products to consumer trends and diverse market factors.

BASES Renovator balances the need to adapt while strengthening brand performance through a fast, interactive software platform. Using a patent-pending methodology, BASES Renovator blends both in and out of competitive context evaluations. The resulting insights provide a clear picture of how making changes will impact the financial well-being, competitive interaction, and strategic outlook of the brand into the future. Additionally, BASES Renovator achieves these results in half the time of traditional other solutions.

“The arrival of Renovator comes at a very good time,” said Joe Willke, President of NielsenIQ BASES. “External factors have forced many of our clients to focus on their core offerings. Renovator is the perfect solution for companies looking to invest and innovate on their existing brands. The robust insights gleaned from this solution will be crucial to successfully compete for consumer purchase while also strengthening the brand’s equity.”

About NielsenIQ

NielsenIQ is the leader in providing the most complete, unbiased view of consumer behavior, globally. Powered by a groundbreaking consumer data platform and fueled by rich analytic capabilities, NielsenIQ enables bold, confident decision-making for the world’s leading consumer goods companies and retailers.

Using comprehensive data sets and measuring all transactions equally, NielsenIQ gives clients a forward-looking view into consumer behavior in order to optimize performance across all retail platforms. Our open philosophy on data integration enables the most influential consumer data sets on the planet. NielsenIQ delivers the complete truth.

NielsenIQ, an Advent International portfolio company, has operations in nearly 100 markets, covering more than 90% of the world’s population. For more information, visit

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Alex Tekip
+1 517-249-1588

Fernanda Paredes

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Taro to Acquire Alchemee From Galderma

  • Alchemee’s flagship brand Proactiv® is an iconic product synonymous with acne care

ZUG, Switzerland & HAWTHORNE, N.Y.-Wednesday 23 February 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- Galderma and Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro”) announced today they have signed a definitive agreement for Taro to acquire Alchemee, formerly The Proactiv Company (TPC), from Galderma. The agreement between Galderma and Taro includes Alchemee’s business and assets around the world, including the Proactiv® brand.


"We are excited to add Proactiv® to Taro’s broad portfolio of prescription and over-the-
counter dermatology products. We look forward to welcoming the Alchemee team into Taro

and working together to continue to make a difference to the millions of people living with
acne around the world.




Proactiv® has been used and trusted by millions around the world for more than 25 years. Originally set up as a subscription-based business, Proactiv® quickly became a leading U.S. consumer acne brand.


“We are proud of the work we have done together to serve customers suffering from acne
around the world through Proactiv®. I am confident that Taro is the right owner to build on
Alchemee’s strong foundation. Their vision is aligned to Alchemee, which comes with an
incredible legacy and brand equity, and a great team with a clear plan for future success.”


The acquisition is subject to customary closing conditions and any necessary regulatory approvals. Financial terms of the transaction have not been disclosed.

About Alchemee
At Alchemee, we aspire to inspire. We are alchemists at heart, harnessing science to create powerful wellness solutions. The combination of alchemy and “me” offers the right mixture of science, expertise, and support that empowers our customers with confidence. Through one-of-a-kind expert-designed formulas and positive guidance, Alchemee provides solutions that are as effective as they are transformative. At Alchemee, we are committed to empowering the world one person at a time. Alchemee. Transformation beyond expectation.

About Galderma
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information:

About Taro
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro Pharmaceutical Industries Ltd., please visit the Company’s website at

Forward-Looking Statements

Some of the information contained in this press release may contain forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Neither Galderma, Alchemee, nor Taro has any obligation to publicly update or revise any forward-looking statements.

This press release features multimedia. View the full release here:


Media Contact
Christian Marcoux, M.Sc.
Chief Communications Officer
+41 76 315 26 50

Sébastien Cros
Director, Global Communications
+41 79 529 59 85

William J. Coote
VP, Chief Financial Officer
(914) 345-9001

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AHF Africa Hails Malawi Government Decision to Axe Duty and Excise Tax on Sanitary Pads

 KAMPALA, Uganda-Saturday 26 February 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- AIDS Healthcare Foundation (AHF), Africa Bureau today applauded the decision of the Malawi government to remove taxes on sanitary pads. The news of duty and excise tax exemption for sanitary products is a win for organizations and stakeholders, including AHF Malawi, who have championed this advocacy due to the crucial role affordability and accessibility of sanitary pads play in girls’ education and their well-being.

"We commend the government for this bold move. Reducing the cost of sanitary pads will increase access to this important commodity to girls and consequently increase their school attendance and performance. This is a dream come true and an aspiration of every prosperous country," said Triza Hara, Country Program Manager, AHF Malawi. "We look forward to a time when the government will take this a step further and provide free sanitary pads to poor, school-going girls whose parents struggle to provide clean, sanitary pads to the girls every month,” she added.

According to a UNESCO report, 1 in 10 girls in Sub-Saharan Africa misses school during their menstrual periods, which is about 20% of a given school year, and so many more drop out of school completely once they start menstruating due to a lack of sanitary pads and menstrual health services. Beyond menstrual health services, there have been growing concerns about how the lack of access to sanitary pads puts young women and girls at risk of contracting HIV.

"When young women and girls miss out on schooling, it increases their risks of being targets for transactional sex and acquiring HIV. They also miss out on critical health information and education that empowers them to make more informed choices," explained Oluwakemi Gbadamosi, Director Advocacy, Policy and Marketing, AHF Africa Bureau.

“This kind of progressive decision is not only emboldening for girls but will have a profound, lasting impact in keeping them in school, living productive lives and staying healthy —which includes reducing risks of HIV. We congratulate the government of Malawi for joining an increasing number of countries on the continent that have removed taxes on sanitary pads and hope this inspires many more to tow this path," she stressed.

The advocacy around sanitary pads is a pillar of the AHF Girls Act program, an initiative that empowers young women and girls with information and services on HIV/AIDS, sexual and reproductive health, menstrual hygiene management, school scholarships, and psychosocial support for better health outcomes. Additionally, in 2021, AHF launched its five million sanitary pads campaign drive dubbed "A Necessity, Not a Luxury!", which reinforced the need for collective action towards championing menstrual health support for girls.

About AIDS Healthcare Foundation (AHF)

AIDS Healthcare Foundation, the largest global AIDS organization, currently provides medical care and/or services to over 1.6 million people in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Europe. To learn more about AHF, please visit our website:, find us on Facebook: and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare.

This press release features multimedia. View the full release here:



Triza Hara, Country Program Manager

AHF Malawi

+265 887 885 195


Oluwakemi Gbadamosi, Director, Advocacy, Policy & Marketing


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Covetrus Announces New Structure, Focus and Strength within Europe


PORTLAND, Maine -Tuesday 21 December 2021 [ AETOS Wire ]

    Accelerating into 2022, in accordance with the company’s three-year strategic plan, with a new Northern European leadership team and reset for the company’s German and U.K. businesses
    Continuing to organize the company’s International business around the customer and operate as an increasingly customer-centric organization
    Creating a DACH headquarters in Dusseldorf, Germany to concentrate strengths of Germany, Austria and Switzerland-based teams along with the company’s other Central European locations
    Driving efficiencies to strengthen International commercial capabilities and competitive advantage and accelerating the value creation for all stakeholders

(BUSINESS WIRE)-- Covetrus® (Nasdaq: CVET), a global leader in animal-health technology and services, today announced a new organizational structure within Northern and Central Europe to execute the company’s three-year strategy, deliver operational efficiencies, and better enable the company’s combined commercial teams to service their customers and provide a reset for the German and U.K. businesses.

Earlier this year, Covetrus announced the hiring of András Bolcskei as Covetrus’ first president of International. Mr. Bolcskei was charged with bringing all commercial teams outside of North America together, and today’s announcement advances that plan. Key changes include the development of a new International leadership team and a concerted focus within the U.K. and German businesses, an anticipated element of the company’s strategic plan, as well as an immediate and strong reaction to recent pressures within those two regions.

Covetrus Germany will move its DACH headquarter from Hamburg to Düsseldorf. Effective April 1, 2022, Covetrus’ Düsseldorf location will create the DACH hub for the company under the leadership of Dr. Andreas Tschuor and will restrengthen its commercial capabilities, service to customers and competitiveness within the German market. In addition, the proximity of Düsseldorf to two other Covetrus regions (Belgium and the Netherlands) will enable and lead to increased efficiencies and operational excellence within those regions’ commercial teams. The company will close its Hamburg office on March 31, 2022. Employment contracts tied to Hamburg will be discontinued, and employees will be offered the choice to continue employment with unchanged conditions in the new Düsseldorf office on April 1, 2022.

Development of a new leadership team to drive the company’s International Business. Effective January 1, 2022, and similar to the structure adopted in the U.S. earlier this year, the U.K. commercial and the Global Technology Solutions (GTS) teams, and the U.K. & Europe sales teams will come under one, unified commercial leadership, led by Loic Jegou, Country Manager and VP, Northern Europe. Mr. Jegou joined Covetrus last month with 18 years of experience in the animal health pharmaceutical business at Pfizer and MSD Animal Health. The U.K. business will increase service to U.K.-based customers through an extended focus of the company’s “One Face to Customer” approach. Additionally, in keeping with a true International approach, Australia and New Zealand are adopting the same go-to-market strategy, and the GTS sales team within the APAC region will report directly to Simon Hellams, VP, APAC. Covetrus is uniquely suited, within the animal health industry, to meet their customers’ overall needs with a single point of contact due to Covetrus’ expansive product and service offering and breadth of capabilities.

“These moves position Covetrus to win for our European customers and win for our global business,” said Ben Wolin, President & CEO. “I have absolute confidence in our ability to drive our strategy, win back our position within the German and U.K. markets, drive greater outcomes for our customers and the animals they care for … and drive success for all our teams and stakeholders.”

About Covetrus

Covetrus is a global animal-health technology and services company dedicated to empowering veterinary practice partners to drive improved health and financial outcomes. We are bringing together products, services, and technology into a single platform that connects our customers to the solutions and insights they need to work best. Our passion for the well-being of animals and those who care for them drives us to advance the world of veterinary medicine. Covetrus is headquartered in Portland, Maine with more than 5,500 employees serving over 100,000 customers around the globe. For more information about Covetrus visit

Forward-Looking Statements

This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties, including statements about our plans, objectives, expectations, and intentions. Such statements are subject to numerous risks and uncertainties. Factors that could adversely affect our business and prospects are set forth in our public filings with the Securities and Exchange Commission. Our forward-looking statements are based on current beliefs and expectations of our management team and, except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise. Investors are cautioned not to place undue reliance on these forward-looking statements.

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Investor Contact
Nicholas Jansen
(207) 550-8106

Media Contact
Mona Downey

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