Business Wire

Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE’ Study in Adults with Transfusion-Dependent Beta-Thalassemia

Del

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced results from a phase III, randomized, double-blind, multi-center clinical study (BELIEVE). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33 percent reduction from baseline in red blood cell (RBC) transfusion burden with a reduction of at least 2 units during the protocol-defined period of 12 consecutive weeks, from week 13 to week 24, compared to placebo.

BELIEVE evaluated the efficacy and safety of luspatercept plus best supportive care versus placebo plus best supportive care in adults with transfusion-dependent beta-thalassemia.

In addition to achieving the primary endpoint of the study, luspatercept also met all key secondary endpoints of demonstrating statistically significant improvements in RBC transfusion burden from baseline of at least a 33 percent reduction during the period from week 37 to week 48, at least a 50 percent reduction during the period from week 13 to week 24, at least a 50 percent reduction during the period from week 37 to week 48, and a mean change in transfusion burden from week 13 to week 24.

Adverse events observed in the study were generally consistent with previously reported data.

“For decades, the management of beta-thalassemia in adults has been limited to transfusions and iron chelation. Reduction of transfusion burden represents an important step forward for patients with this rare and debilitating blood disease,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We thank the patients, as well as their families and physicians, for their participation in the BELIEVE study.”

“The BELIEVE study marks the second positive phase III study for luspatercept and underscores the potential of this erythroid maturation agent to impact a range of diseases associated with chronic anemia,” said Habib Dable, President and Chief Executive Officer of Acceleron. “We continue to explore luspatercept across our broader development programs, including non-transfusion dependent beta-thalassemia in the ongoing BEYOND study.”

The companies also recently announced that luspatercept met the primary and key secondary endpoints in the MEDALIST study, a phase III, randomized, double-blind, multi-center clinical trial evaluating the efficacy and safety of luspatercept versus placebo in patients with IPSS-R very low, low or intermediate risk myelodysplastic syndromes (MDS) with chronic anemia and refractory to, intolerant of, or ineligible for treatment with an erythropoietin-stimulating agent (ESA), ring sideroblast-positive and require frequent RBC transfusions.

Data from BELIEVE and MEDALIST will be submitted to a future medical meeting in 2018. The companies plan to submit regulatory applications for luspatercept in the United States and Europe in the first half of 2019.

Luspatercept is not approved for any indication in any geography.

About Luspatercept

Luspatercept is a first-in-class erythroid maturation agent (EMA) that is believed to regulate late-stage red blood cell maturation. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase III clinical trials continue to evaluate the safety and efficacy of luspatercept in patients with MDS (the MEDALIST trial) and in patients with beta-thalassemia (the BELIEVE trial). A Phase III trial is being planned in first-line, lower-risk, MDS patients (the COMMANDS trial). The BEYOND Phase II trial in non-transfusion-dependent beta-thalassemia and a Phase II trial in myelofibrosis are ongoing. For more information, please visit www.clinicaltrials.gov.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical 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: @CelgenePinterestLinkedInFacebook and YouTube.

About Acceleron

Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company's leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchise with two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with sotatercept in pulmonary arterial hypertension.

For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of, and plans relating to the collaboration between Acceleron and Celgene; the potential of luspatercept as a therapeutic drug; and the benefit of each company’s strategic plans and focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs. For example, there can be no guarantee that luspatercept will be successfully developed or complete necessary clinical phases. Forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other important factors, including: results of clinical trials, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; the ability to obtain and maintain requisite regulatory approvals and to enroll patients in planned clinical trials; the ability to obtain, maintain and enforce patent and other intellectual property protection for luspatercept; the ability to maintain key collaborations; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in each company’s public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and neither company has any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Hyperlinks are provided as a convenience and for informational purposes only. Neither Celgene nor Acceleron bears responsibility for the security or content of external websites or websites outside of their respective control.

Contact information

Celgene Corporation
Investors:
+1-908-673-9628
ir@celgene.com
or
Media:
+1-908-673-2275
media@celgene.com
or
Acceleron Pharma Inc.
Todd James, IRC, (617) 649-9393
Vice President, Investor Relations and Corporate Communications
or
Candice Ellis, 617-649-9226
Manager, Investor Relations and Corporate Communications
or
Media:
Matt Fearer, 617-301-9557
Director, Corporate Communications

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Bank of Singapore is the First Singapore Private Bank to Receive Regulatory Approval to Open a Wealth Management Subsidiary in Luxembourg16.7.2018 09:36Pressemelding

Bank of Singapore today announced that it has been granted an investment company licence to operate a wealth management subsidiary in Luxembourg – a first for a Singapore private bank. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005252/en/ (Photo: BOSWM) Bank of Singapore, through this new subsidiary, BOS Wealth Management Europe Société Anonyme (S.A.), will be able to offer a comprehensive range of customised private banking solutions and investment advisory services to its ultra-high and high net worth clients in the European Economic Area (“EEA”) and the United Kingdom (“UK”). The EEA comprises the European Union (EU) countries and Iceland, Liechtenstein and Norway. Currently, Bank of Singapore serves its European clients from its Singapore headquarters and through its parent company OCBC Bank’s London office. There has been robust growth in assets under management from EEA clients as they hold Singapore in high

Primex Pharmaceuticals Appoints Tomaso Dameno as Head of Operations16.7.2018 09:02Pressemelding

Mr. Dameno brings more than 15 years of experience in the pharmaceutical industry to Primex Pharmaceuticals. Most recently, he was Partner and Head of Global Pharma Compliance Operations at PQE Suisse. He has held various pharma line management roles at e.g. Zambon and Helsinn. “I am excited to join Primex at this fast growth stage of its development and on the brink of such an important product launch on the pediatric anesthetic market. My extensive knowledge of the different aspects of the pharmaceutical business will help smooth the path to new markets,” says Tomaso Dameno. Mr. Dameno’s key responsibilities are strategic and operative performance ensuring the development of the global supply chain, heading the regulatory, quality and pharmaceutical safety management functions, as well as contract manufacturing and logistics. He will be part of the Executive Team headed by CEO Kari Sarvanto in Zug, Switzerland. Mr. Sarvanto comments: “I am pleased to see Primex is constantly able to

Orange Acquires Basefarm Holding and Becomes a European Leader in Cloud Computing Services for the Enterprise Sector16.7.2018 07:22Pressemelding

Following a competitive tender process initiated by Abry Partners for its stake in Basefarm, the Orange Group, through its enterprise subsidiary Orange Business Services, has announced today the signature of a contract to acquire 100% of the company’s capital for an enterprise value of 350 million euros. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005214/en/ Basefarm is a leading European player in cloud-based infrastructure and services, as well as the management of critical applications and data analysis. The company, which recorded revenues of over 100 million euros in 2017, has enjoyed strong growth since 2015. Basefarm has a strong operational presence in several European countries, particularly in Norway, Sweden, the Netherlands, Austria and in Germany, where it boasts a cutting-edge big data activity. Its business proposition lies at the forefront of the most innovative services in cloud computing, Big Data a

Spirit AeroSystems and Norsk Titanium Announce Start of Production Qualification for Commercial Aircraft Parts16.7.2018 07:00Pressemelding

Spirit AeroSystems [NYSE: SPR] and Norsk Titanium US Inc. (NTi), have reached an agreement to initiate qualification of Spirit’s first additive-manufactured, titanium, structural component for the Boeing 787. This qualification will validate NTi’s production and industrialization processes, integrate Spirit’s workscope of machining final parts from additively manufactured near-net shapes and verify material and final part conformity to requirements. “Spirit has had a comprehensive and long relationship with Norsk Titanium, and this part will be our first additive structural titanium component incorporated into a commercial airplane program,” said Spirit AeroSystems Senior Vice President of Fabrication and Supply Chain Management, Ron Rabe. NTi is the world’s first FAA-approved, OEM qualified, supplier of additive-manufactured, structural titanium components. NTi’s proprietary Rapid Plasma Deposition™ (RPD™) process has been in serial production of Boeing 787 titanium components since A

New Study Investigates the Utility of Masimo PVi® as Part of Goal-Directed Fluid Management in Patients Undergoing Colorectal Surgery16.7.2018 05:00Pressemelding

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Kocaeli University in Turkey compared the performance of conventional fluid management (CFM) to goal-directed fluid management (GDFM) using Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) in patients undergoing elective colorectal surgery. The primary points of comparison were the amount of crystalloids administered and blood lactate and serum creatinine levels during the intraoperative period.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005048/en/ Masimo Radical-7® with PVi®, SpHb®, and RD rainbow SET™ Sensor (Photo: Business Wire) In the study, Dr. Cesur and colleagues, noting the importance of intraoperative fluid management in terms of postoperative organ perfusion and complications, sought to compare the effects of CFM (guided by clinical asse

Alipay and Singapore Tourism Board join hands to boost Chinese tourist spending16.7.2018 02:00Pressemelding

Alipay, the world’s leading mobile and online payment and lifestyle platform operated by Ant Financial Services Group, together with the Singapore Tourism Board (STB), have launched a series of joint marketing initiatives aimed at raising destination awareness of Singapore and driving tourist spending among Chinese visitors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180715005021/en/ Alipay and STB signed a Memorandum of Understanding (MOU) in September 2017 to enhance Chinese tourists’ overall experience in Singapore. Under the MOU, both parties agreed, among other things, to explore co-investing in joint-marketing initiatives to encourage Chinese tourists to spend with Alipay while in Singapore. Since signing the MOU, Alipay has experienced double-digit growth in user spending. China has also become Singapore’s top market in 2017 for both tourism receipts and visitor arrivals, contributing S$4.2 billion in tourism rece