Celgene Corporation and Acceleron Pharma to Present ACE-011 Data at the 50th Annual Meeting of the American Society of Hematology

Clinical Results Demonstrate Novel Mechanism Increases Bone Mineral Density and Increases Levels of Hemoglobin and Hematocrit

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 3, 2008 - Celgene Corporation (NASDAQ:CELG) and Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced that results from preclinical and clinical studies of ACE-011 will be presented at the annual meetings of the American Society of Hematology and the San Antonio Breast Cancer Symposium over a three day period starting on December 8, 2008. The data to be presented at these well-regarded medical conferences highlight the unique clinical potential of ACE-011.

ACE-011 is a novel biologic agent that binds tightly to activin and inhibits signaling through the activin type IIA receptor (ActRIIA). Activin signaling through the ActRIIA receptor regulates bone metabolism, red blood cell formation and reproductive tissue including breast. In animals, the administration of soluble ActRIIA has been shown to promote new bone formation, inhibit the growth of breast tumors and increase red blood cell formation. In humans, ACE-011 has been shown to promote new bone formation, increase bone mineral density (BMD) and substantially increase hemoglobin/hematocrit levels. Results demonstrating these effects from recently completed clinical trials and preclinical studies of ACE-011 will be presented at the following times and locations.

50th Annual American Society of Hematology Meeting and Exposition, San Francisco, California, December 6-9, 2008

 

  • “RESTORATION OF BONE BALANCE VIA ACTIVIN A INHIBITION RESULTS IN ANTI-MYELOMA ACTIVITY” (Oral Presentation); Rooms 2009-2011-2022-2024 – Moscone Center West, December 8th, 4:15 PM
  • “ACE-011, A SOLUBLE ACTIVIN RECEPTOR TYPE IIA IGG-FC FUSION PROTEIN, INCREASES HEMOGLOBIN AND HEMATOCRIT LEVELS IN POSTMENOPAUSAL HEALTHY WOMEN” (Poster III-948); Exhibit Hall A, December 8th, 5:30 - 7:30 PM

31st Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas, December 10-14, 2008

 

  • “RAP-011, A SOLUBLE ACTIVIN RECEPTOR TYPE IIA IGG-FC FUSION PROTEIN, IS A NOVEL BONE ANABOLIC AGENT THAT PREVENTS BONE LOSS AND SKELETAL METASTASES IN A MOUSE MODEL OF METASTATIC BREAST CANCER” (Poster #1158); December 11th, 5:30 – 7:30 PM
  • “ACE-011, A SOLUBLE ACTIVIN RECEPTOR TYPE IIA IGG-FC FUSION PROTEIN, DECREASES FOLLICLE STIMULATING HORMONE AND INCREASES BONE-SPECIFIC ALKALINE PHOSPHATASE, A MARKER OF BONE FORMATION, IN POSTMENOPAUSAL HEALTHY WOMEN” (Poster #1160); December 11th, 5:30 – 7:30 PM

About ACE-011

ACE-011, a soluble form of the activin receptor type IIA (ActRIIA), is a biologic therapeutic that inhibits signaling through the ActRIIA receptor. By blocking signaling through ActRIIA, ACE-011 stimulates bone formation and increases red blood cell production. In numerous animal models of diseases involving bone loss, ACE-011 significantly increased bone mineral density, improved bone architecture, increased bone formation rate and bone mechanical strength. In Phase 1 clinical studies in healthy volunteers, ACE-011 had an encouraging safety profile, increased biomarkers of bone formation, bone mineral density and levels of hemoglobin and hematocrit. ACE-011 is being jointly developed by Acceleron and Celgene Corporation.

About Celgene/Acceleron Collaboration

On February 20, 2008, under the terms of the agreement, Celgene and Acceleron announced that they will jointly develop, manufacture and commercialize Acceleron's products for bone loss. Celgene made an upfront payment to Acceleron of $50 million, which included a $5 million equity investment in Acceleron. In addition, in the event of an initial public offering of Acceleron, Celgene will purchase a minimum of $7 million of Acceleron common stock.

Acceleron is responsible 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 ACE-011 program and up to an additional $437 million for each of the three discovery stage programs. Both companies will co-promote the products in North America. Acceleron will receive tiered royalties on worldwide net sales.

About Celgene

Celgene Corporation, based in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel 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 biotherapeutics that modulate the growth of bone, muscle, red blood cells, fat and the vasculature to treat musculoskeletal, metabolic and cancer-related diseases. Acceleron's scientific approach takes advantage of its unique insight into the regenerative powers of the Growth and Differentiation Factor (GDF) family of proteins. ACE-011 is the Company's lead program and is being developed across a variety of diseases. In addition, the company is advancing through preclinical development product candidates that increase muscle mass, control angiogenesis and inhibit fat accumulation. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company's internal GMP manufacturing capability to rapidly and efficiently advance its therapeutic programs. The investors in Acceleron are Advanced Technology Ventures, Bessemer Ventures, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For more information, visit www.acceleronpharma.com.

 

 

Contact: Acceleron Pharma:
Steven Ertel, 617-649-9234
Vice President, Corporate Development
or
Suda Communications LLC
Paul Kidwell (Media), 617-296-3854
or
Celgene Corporation:
Greg Geissman, 908-673-9854
Associate Director, Public Relations
 

 

 

Posted: December 2008

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