Celgene and Acceleron Initiate Phase 2/3 Study of ACE-011 (sotatercept) to Treat Chemotherapy-Induced Anemia in Patients w

SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, and Celgene Corporation (NASDAQ: CELG) today announced the initiation of the first part of a Phase 2/3 clinical study of ACE-011 (sotatercept) for the treatment of chemotherapy-induced anemia (CIA) in patients with metastatic non-small cell lung cancer (NSCLC). Celgene Corporation will make a $7 million milestone payment to Acceleron in accordance with the terms of the collaboration agreement between the two companies.

“We are excited to see the initiation of this late-stage clinical trial of sotatercept as there is enormous unmet medical need for a safe and effective alternative to ESAs for the treatment for chemotherapy-induced anemia,” said Matthew Sherman, MD, Chief Medical Officer of Acceleron. “This study, along with an ongoing Phase 2 clinical trial in patients with end-stage renal disease on hemodialysis, will provide insight into the therapeutic potential of sotatercept as a first-in-class treatment for anemia.”

The clinical trial is designed as a randomized, dose ranging study of sotatercept in patients with metastatic cancer followed by a double-blind, randomized, placebo-controlled study of sotatercept for chemotherapy-induced anemia (CIA) in patients with metastatic non-small cell lung cancer (NSCLC) treated with first-line platinum-based chemotherapeutic regimens. For additional information on the clinical trial, please visit clinicaltrials.gov and query NCT01284348.

About Chemotherapy-Induced Anemia (CIA)

Anemia is one of the most common and debilitating complications associated with cancer chemotherapy, which depletes and prevents formation of red blood cells, leading to fatigue and weakness. Recent studies of erythropoietin-stimulating agents (ESAs) have shown an increased risk of mortality arising from exposure to high levels of recombinant erythropoietin and its derivatives, which may stimulate tumor progression and increase the occurrence of thromboembolic events. Currently, blood transfusions are the only effective alternative treatment for anemia, and are associated with the risk of transmissible diseases. There is a significant unmet need for safe and effective alternatives to ESAs and transfusions for the management of CIA.

About ACE-011 / sotatercept

Sotatercept, a soluble receptor fusion protein comprised of extracellular domain of the human activin receptor type IIA (ActRIIA) fused to human immunoglobulin, is a biologic therapeutic. Blocking signaling through ActRIIA may be a way to increase red blood cell production, promote bone formation, and inhibit tumor growth and metastasis. Sotatercept is the first in a novel class of anemia therapies. In Phase 1 clinical studies in healthy volunteers, sotatercept was generally well tolerated, and increased levels of hemoglobin and hematocrit, biomarkers of bone formation, and bone mineral density. The most common clinically significant adverse events observed included increased hemoglobin and increased hematocrit, which were expected pharmacologic effects of the drug, and also headache, all of which were manageable and reversible. Sotatercept is currently being studied in Phase 2 clinical trials in patients with chemotherapy-induced anemia and in patients with end-stage renal disease on hemodialysis. For more information on ongoing and completed clinical trials of sotatercept, visit clinicaltrials.gov and query “sotatercept.” Sotatercept is being jointly developed by Acceleron and Celgene Corporation.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com.

About Acceleron

Acceleron is a privately-held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel protein therapeutics for orphan diseases and cancer. Acceleron’s scientific approach takes advantage of its unique insight to discover first-in-class therapies based on the TGF-β protein superfamily. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company’s internal GMP manufacturing capability to advance its therapeutic programs rapidly and efficiently. The investors in Acceleron include Advanced Technology Ventures, Alkermes, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For further information on Acceleron Pharma, please visit www.acceleronpharma.com.

About Acceleron/Celgene Collaboration

Under the terms of the agreement, Celgene and Acceleron will jointly develop, manufacture and commercialize sotatercept. Acceleron will retain responsibility for initial activities, including research and development, through the end of Phase 2a clinical trials, as well as manufacturing the clinical supplies for these studies. In turn, Celgene will conduct the Phase 2b and Phase 3 clinical studies and will oversee the manufacture of Phase 3 and commercial supplies. Acceleron will pay a share of the development expenses and is eligible to receive development, regulatory and commercial milestones of up to $510 million for the sotatercept program and up to an additional $437 million for each of three discovery stage programs. The companies will co-promote the products in North America. Acceleron will receive tiered royalties on worldwide net sales.

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Acceleron Pharma
Steven Ertel, 617-649-9234
Senior Vice President, Corporate Development
Suda Communications LLC
Maureen L. Suda, 585-387-9248
Celgene Corporation
Greg Geissman, 908-673-9854
Associate Director, Public Relations

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