Acceleron related Press Releases

Acceleron Secures $30M Private Financing

Fri, 23 Dec 2011 09:21:03 -0500

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma, Inc., a biopharmaceutical company developing protein therapeutics for cancer and orphan diseases, today announced it raised a $30M private financing. Celgene, one of Acceleron’s strategic partners, and all other existing investors participated in this financing. The proceeds will be used to expand and advance Acceleron’s clinical stage pipeline and to continue to support its highly productive research engine.

“This fortifies Acceleron’s solid financial position and provides the Company with the resources to continue to advance and expand our robust clinical and preclinical pipeline”, said John Knopf, Ph.D., Chief Executive Officer of Acceleron. “We’re especially pleased with Celgene’s commitment to Acceleron as we jointly develop several promising products for the treatment of anemia.”

In conjunction with this financing, George Golumbeski, Senior Vice President of Corporate Development of Celgene, has joined the Acceleron Board of Directors.

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, Avalon Ventures, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For further information on Acceleron, please visit www.acceleronpharma.com.

CONTACT:

Acceleron Pharma:
Steven Ertel, 617-649-9234
Senior Vice President, Corporate Development
or
Maureen L. Suda (Media)
Suda Communications LLC, 585-387-9248

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Oncology Pharmaceutical Professional Services Banking Finance Research Science

MEDIA:

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Acceleron Pharma Announces Global Collaboration with Celgene Corporation on ACE-536 Program

Erica Teichert — Wed, 03 Aug 2011 09:08:05 -0400

Expands Upon Existing Sotatercept (ACE-011) Partnership by Entering a New Agreement to Form Broad Anemia Collaboration

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 that the companies have entered into a joint development and commercialization agreement for ACE-536 for the treatment of anemia. The companies already have a collaboration around sotatercept (ACE-011) entered in 2008. Under the new agreement, the companies will collaborate to develop both products and potentially others for treating anemia across a wide range of indications.

Celgene and Acceleron will jointly develop, manufacture and commercialize ACE-536, a novel protein therapeutic that inhibits members of the TGF-beta superfamily involved in erythropoiesis, for the treatment of anemia. Additionally, Celgene will have an option to future Acceleron programs developed for anemia. Celgene will make an upfront payment to Acceleron of $25 million.

"Acceleron has uncovered an exciting new approach to treating disorders of erythropoiesis, and we are pleased to broaden our successful partnership with Celgene," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "Acceleron and Celgene can now combine our strengths to develop molecules to treat a broad array of under-served diseases and conditions in which patients suffer from anemia. To that end, we look forward to initiating the Phase 1 clinical trial of ACE-536 within the next few months. ACE-536 is our fourth internally discovered and developed drug to enter the clinic."

"Celgene and Acceleron have a strong partnership that continues to advance innovative therapies in areas of great unmet medical need," said Tom Daniel, Ph.D., President, Research, Celgene. "The work we will embark on with ACE-536 is a natural extension of our strong presence in hematology. We look forward to exploring the potential of ACE-536 for patients with anemia worldwide."

Under the terms of the agreement, Acceleron will be responsible for conducting the Phase 1 and initial Phase 2 clinical trials and Celgene will conduct the subsequent Phase 2 and Phase 3 clinical studies. Acceleron will manufacture ACE-536 for the Phase 1 and Phase 2 clinical trials and Celgene will have responsibility for the manufacture of Phase 3 and commercial supplies. Acceleron will pay a share of the development expenses through the end of 2012 and Celgene will be responsible for development costs thereafter. Acceleron is eligible to receive development, regulatory and commercial milestones of up to $217 million for the ACE-536 program. The companies will co-promote the products in North America. Acceleron will receive tiered double-digit royalties on worldwide net sales.

About ACE-536

ACE-536 is a ligand trap that inhibits members of the TGF-beta superfamily involved in late stages of erythropoiesis. ACE-536 and sotatercept are biochemically distinct molecules and may have unique pharmacological attributes that enable their preferential use in particular anemia indications. In preclinical studies, ACE-536 promotes red blood cell (RBC) formation in the absence of erythropoietin (EPO) signaling, has distinct effects from EPO on RBC differentiation, and acts on a different population of progenitor blood cells than EPO during RBC development.

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 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, please visit www.acceleronpharma.com.

Acceleron Pharma Initiates Phase 2 Clinical Trial with ACE-031 in Patients with Duchenne Muscular Dystrophy

Lauren Lentini — Fri, 07 May 2010 11:12:26 -0400

Acceleron Pharma Initiates Phase 2 Clinical Trial with ACE-031 in Patients with Duchenne Muscular Dystrophy

Study will explore safety, tolerability and effects of ACE-031 on body composition, muscle strength and function in ambulatory patients

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 5, 2010 - Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced the initiation of a Phase 2 clinical trial with ACE-031 in patients with Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease. ACE-031 is an investigational protein therapeutic that builds muscle and increases strength by inhibiting signaling of a cell surface receptor called the activin receptor type IIB (ActRIIB).

"We are enthusiastic about the therapeutic potential for ACE-031 in DMD based on its compelling preclinical and clinical activity," said Matthew Sherman, M.D., Chief Medical Officer at Acceleron. "DMD patients suffer from progressive muscle weakness that gradually impairs their ability to walk, breathe voluntarily and live independently, and treatment with ACE-031 has the potential to increase muscle strength and slow the progression of the disease."

"In preclinical studies in the mdx mouse model of DMD, ACE-031 has shown potent effects on increasing muscle mass," said Jasbir Seehra, PhD, Chief Scientific Officer and co-founder of Acceleron. "These studies have also demonstrated improvements in muscle strength and function, which we hope will translate directly to the clinical setting in patients with DMD."

About the Phase 2 Clinical Trial in Duchenne Muscular Dystrophy

The Phase 2 trial is a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of ACE-031 in patients with DMD receiving concurrent corticosteroid treatment. In addition, the study will characterize the effects of ACE-031 on lean tissue (muscle) mass, muscle strength, muscle function, pulmonary function and quality of life. In a single-dose Phase 1 study of ACE-031 in healthy post-menopausal women, rapid and sustained dose-dependent increases in lean mass and muscle volume were observed, along with improved markers of bone resorption and formation.

The study is being conducted at multiple sites in Canada. Acceleron is in discussions with regulatory authorities in several other countries regarding possible expansion of the study into those countries. For a more detailed description of the clinical trial protocol, inclusion and exclusion criteria, and a list of participating sites, please visit clinicaltrials.gov and query NCT01099761 as the study identifier.

About Duchenne Muscular Dystrophy (DMD)

Duchenne Muscular Dystrophy (DMD) is a debilitating and fatal genetic disorder characterized by the progressive loss of muscle strength and function. It primarily affects boys and occurs in approximately 1 in every 3,500 live male births. DMD is caused by genetic mutations that result in the absence or a defect in dystrophin, a protein necessary to maintain the structural integrity of muscle fibers. This condition leads to deterioration of and damage to skeletal muscles, which eventually become infiltrated by non-functional scar and fatty tissue. As a result, patients suffer from a relentless decline in muscle strength that impairs their ability to walk, breathe and live independently. Many patients spend the majority of their lives confined to wheelchairs and eventually lose all upper body function. Few patients survive beyond their late-20s when their heart and respiratory muscles weaken and eventually fail.

About ACE-031

ACE-031 is an investigational protein therapeutic that builds muscle and increases strength by inhibiting signaling through a cell surface receptor called activin receptor type IIB (ActRIIB). ACE-031 is a completely human, recombinant fusion protein that is produced by joining a portion of the human ActRIIB receptor to a portion of a human antibody. This creates a freely circulating, decoy version of ActRIIB which removes proteins, such as GDF-8 (myostatin), that limit the growth and regeneration of muscle. Recent studies with ACE-031 suggest that blocking signaling through ActRIIB may be a powerful way to increase muscle mass and improve physical function. In a range of animal models of muscle disease, including models of muscular dystrophy, amyotrophic lateral sclerosis and muscle loss related to corticosteroid treatment, androgen deprivation or advanced age, ACE-031 increased muscle mass, strength and physical function.

About Acceleron

Acceleron is a privately held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel biotherapeutics that modulate the growth of red blood cells, bone, muscle, 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 TGF-Î² superfamily of proteins. ACE-011 is in a Phase 2 clinical trial in patients with anemia. ACE-031 is being studied in a Phase 2 clinical trial in patients with Duchenne Muscular Dystrophy and ACE-041 is being studied in a Phase 1 clinical trial in patients with advanced cancer. In addition, the company is developing several other new product candidates that increase muscle mass, control angiogenesis, inhibit fat accumulation and increase bone mass and strength. 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 include Advanced Technology Ventures, Alkermes, Bessemer Ventures, Celgene, 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
Media:
Suda Communications LLC
Paul Kidwell, 617-296-3854

Alkermes Licenses Technology Platform for Long-Acting Fusion Proteins from Acceleron Pharma

Maureen Martino — Thu, 03 Dec 2009 22:14:18 -0500

Alkermes Licenses Technology Platform for Long-Acting Fusion Proteins from Acceleron Pharma

Lead Candidate is Long-Acting TNF Inhibitor; Alkermes Expects to File IND in 2010

CAMBRIDGE, Mass., Dec 03, 2009 - Alkermes, Inc. (NASDAQ: ALKS) and Acceleron Pharma, Inc. today announced that Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion(TM) technology, which is designed to extend the circulating half-life of proteins and peptides. The first drug candidate being developed with this technology is a long-acting form of a TNF receptor-Fc fusion protein for the treatment of rheumatoid arthritis (RA) and related autoimmune diseases. The TNF receptor-Fc fusion protein is structurally similar to etanercept, commercially known as ENBREL(R), which had worldwide sales of nearly $6 billion in 2008.

Under the terms of the agreement, Alkermes will have worldwide rights to the Medifusion technology in return for an upfront payment and equity investment in Acceleron as well as future development, regulatory and sales milestones and royalties on product sales. Acceleron will retain all rights to the technology for products derived from the TGF-beta superfamily. As part of the agreement, Acceleron will develop up to two selected drug compounds using the Medifusion technology through preclinical studies, at which point Alkermes will assume responsibility for all clinical development and commercialization of these two compounds and any other compounds Alkermes elects to develop resulting from the platform.

"We are very pleased to have in-licensed this novel and broadly applicable technology from Acceleron and look forward to applying this new technology to develop a long-acting TNF candidate," commented Richard Pops, Chief Executive Officer of Alkermes. "In addition to this lead product candidate, we believe there are several other important protein therapeutics for which we can use the Medifusion platform to develop long-acting products that may offer valuable new treatment options for patients."

ALKS 6931, the lead candidate from the Medifusion platform, is a fusion protein of a soluble TNF receptor with the Fc component of human immunoglobulin G1. In vivo studies have shown a significantly extended half-life of ALKS 6931 beyond the half-life of etanercept. Alkermes expects to file an Investigational New Drug Application (IND) for ALKS 6931 in 2010.

"We believe this technology platform for fusion protein optimization could have a major impact on people required to take injections on a frequent basis, and that Alkermes is the ideal collaborator as the clear leader in the development of novel long-acting therapeutics," commented John Knopf, Ph.D., Chief Executive Officer and Founder of Acceleron. "Acceleron has advanced three internally discovered fusion proteins into human clinical trials, each of which is based on our knowledge and expertise in fusion protein optimization. We believe Alkermes will be a great partner to generate value from this promising Fc fusion protein platform."

About Alkermes

Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes developed, manufactures and commercializes VIVITROL(R) for alcohol dependence and manufactures RISPERDAL(R) CONSTA(R) for schizophrenia and bipolar I disorder. Alkermes' robust pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, Alkermes has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.

About Acceleron

Acceleron is a privately held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel biotherapeutics that modulate the growth of red blood cells, bone, muscle, fat and the vasculature to treat musculoskeletal, metabolic and cancer-related diseases. Acceleron has advanced three internally discovered fusion proteins into human clinical trials. ACE-011 is being studied in a Phase 2 clinical trial in breast cancer patients. ACE-031 is currently being studied in a Phase 1 multiple dose clinical trial and ACE-041 is being studied in a Phase 1 clinical trial in patients with advanced cancer. In addition, the company is advancing new product candidates that increase muscle mass, control angiogenesis, inhibit fat accumulation and increase hemoglobin. 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 include Advanced Technology Ventures, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. For more information, visit www.acceleronpharma.com.

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to the preclinical and clinical development of ALKS 6931 and any other candidates, the timing of regulatory filings for ALKS 6931 and whether the companies will be able to create long-acting medications, including ALKS 6931, using this technology platform. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company's business is subject to significant risk and uncertainties and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: the viability of the Fc fusion technology platform for etanercept and any other candidates and actions by the FDA regarding IND filings for these candidates. For further information with respect to factors that could cause the company's actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.

The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.

Medifusion (TM) is a trademark and VIVITROL(R) is a registered trademark of Alkermes, Inc. RISPERDAL(R) CONSTA(R) is a registered trademark of Janssen-Cilag group of companies. ENBREL(R) is a registered trademark of Amgen, Inc.

Acceleron Initiates Phase 1 Clinical Trial for ACE-031 to Treat Diseases Involving Muscle Loss

Calisha Myers — Mon, 20 Oct 2008 09:08:50 -0400

Acceleron Initiates Phase 1 Clinical Trial for ACE-031 to Treat Diseases Involving Muscle Loss

CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 20, 2008--Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced the initiation of a Phase 1 clinical study of ACE-031, its lead compound for treating diseases involving the loss of muscle mass and function. The Phase 1 trial is a randomized, placebo-controlled single-dose, dose-escalating study to evaluate the safety and pharmacokinetics of ACE-031. This clinical trial is the first-in-human study in the global development of ACE-031 and will be conducted in Canada.

"There is a tremendous unmet medical need to treat patients suffering from a wide array of diseases involving the loss of muscle strength and function. ACE-031 has the potential to be a very important new approach to treat these serious and life-threatening conditions," said Matthew Sherman, M.D., Chief Medical Officer of Acceleron.

"The start of this ACE-031 Phase 1 trial is another important clinical milestone for Acceleron," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "Last week we announced the start of a Phase 2 clinical trial in patients with multiple myeloma bone disease with ACE-011, the lead compound in our bone program, and today we are proud to announce the start of the first clinical trial for ACE-031, the lead compound in our muscle program. The Acceleron pipeline continues to mature and expand, and most notably, the company remains in a strong financial position to deliver on our clinical goals. We look forward to several data presentations at major medical meetings before the end of the year that will demonstrate the progress of our pipeline."

Muscle is increasingly recognized as central to many biological processes and plays a major role in human health. The loss of muscle mass and strength is ultimately directly related to the cause of death in neuromuscular diseases such as muscular dystrophy and amyotrophic lateral sclerosis (ALS). Severe muscle loss in cancer leads to serious complications and a poor prognosis. Muscle loss is a natural consequence of aging, similar to bone loss, resulting in decreased muscle strength (frailty), reduced mobility and an increased risk of a fall and broken bones. In metabolic diseases, an imbalance of diet, energy utilization and skeletal muscle leads to poor metabolic function. By increasing muscle mass there is a corresponding decrease in fat mass and improvements in metabolic function.

About ACE-031

ACE-031, a soluble molecule based on the activin receptor type IIB (ActRIIB), is a biologic therapeutic that inhibits signaling through the ActRIIB receptor. By blocking signaling though ActRIIB, ACE-031 increases muscle mass and strength. In numerous and varied animal models of disease, ACE-031 significantly increased muscle mass and muscle strength. ACE-031 has shown encouraging preclinical results in animal models of age-related muscle loss, neuromuscular disease, cancer treatment-related muscle loss and metabolic diseases.

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, 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, a novel bone forming compound, is the Company's lead compound and is being developed to reverse bone loss in diseases such as cancer-related bone loss in a strategic alliance with the multinational biopharmaceutical company Celgene Corporation. ACE-031, a novel muscle building compound, is being developed to increase muscle mass and strength. In addition, the company is advancing through preclinical development product candidates that control angiogenesis and inhibit fat accumulation. Acceleron utilizes proven biotherapeutic technologies and capitalizes on the company's internal Good Manufacturing Practice (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.

Celgene Corporation and Acceleron Pharma Initiate Phase 2 Study of ACE-011 in Patients with Multiple Myeloma

Calisha Myers — Thu, 16 Oct 2008 11:09:19 -0400

Celgene Corporation and Acceleron Pharma Initiate Phase 2 Study of ACE-011 in Patients with Multiple Myeloma

CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 16, 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 the initiation of a Phase 2 clinical study of its lead compound ACE-011 in patients with multiple myeloma. ACE-011 is being developed to treat bone loss associated with multiple myeloma and other cancers. The clinical study is designed to assess the safety and efficacy of ACE-011 in multiple myeloma patients with osteolytic bone lesions. Celgene Corporation will make a $5 million milestone payment to Acceleron in accordance with the terms of the collaboration agreement between the two companies.

"We are excited to begin the first ACE-011 Phase 2 study in multiple myeloma patients suffering from cancer-related bone loss," said Matthew Sherman, M.D., Chief Medical Officer of Acceleron. "We have encouraging results from Phase 1 studies with ACE-011, and believe that it holds promise as a novel bone-forming agent to treat the serious and debilitating effects of bone loss resulting from progression of tumors in myeloma or other cancers. Acceleron plans to present results from the Phase 1 studies at scientific and medical conferences later this year."

The Phase 2, multi-center, randomized, double-blind, placebo-controlled study is designed to assess the safety and efficacy of multiple doses of ACE-011 in multiple myeloma patients with osteolytic bone lesions. The study will be a multi-center trial conducted in Russia and patients will be treated with standardized anti-myeloma therapy consisting of melphalan, prednisone and thalidomide and randomized to receive either monthly doses of ACE-011 or placebo for up to three months. This study is funded in part by a grant from the Multiple Myeloma Research Foundation.

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 though ActRIIA, ACE-011 stimulates bone formation. 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 and increased bone mineral density. ACE-011 is being jointly developed by Acceleron and Celgene Corporation for the treatment of cancer-related bone loss.

About Multiple Myeloma and Metastatic Bone Disease

Multiple myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. When functioning normally, plasma cells are part of the immune system that helps fight infection and disease. In multiple myeloma, the malignant plasma cells form tumors that affect the function of the bone marrow and cause damage to the surrounding bone. This bone damage leads to severe bone pain and fractures of the bone which are disabling and often require surgery or radiation therapy.

Metastatic bone disease is a serious complication that develops when solid tumors metastasize, or spread, from the originally affected organ to bone. These tumors secrete factors in the bone allowing tumor proliferation and causing debilitating bone lesions. Many patients with breast or lung cancer will have tumors that metastasize to the bone and these patients will suffer from severe bone pain and fractures.

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, 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, a novel bone forming agent, is the Company's lead program and is being developed to reverse bone loss in diseases such as cancer-related bone loss. 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.

PRESS RELEASE: Acceleron Pharma Completes $31M Series C Financing

Maureen Martino — Tue, 30 Oct 2007 13:01:31 -0400

Acceleron Pharma Completes $31M Series C Financing

Top venture syndicate invests to advance expanding pipeline of products that modulate tissue growth and repair

Cambridge, Mass. â€“ October 30, 2007 - Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced it raised $31M in a Series C financing. Bessemer Venture Partners led the round along with other new investors MPM BioEquities and QVT Financial. All existing institutional investors participated in the round including Advanced Technology Ventures, Flagship Ventures, OrbiMed Advisors, Polaris Ventures, Sutter Hill Ventures and Venrock.

Acceleron plans to use the proceeds from this financing to advance its clinical and preclinical pipeline and further develop its product platform. In the first quarter of 2008, Acceleron expects to advance its ACE-011 program for bone growth into phase 2 clinical trials and to initiate a phase 1 study of its ACE-031 program for increasing muscle mass and strength. The company expects to bring its third drug candidate, ACE-041, into clinical trials in the second half of 2008.

â€œWe are pleased that these leading investment firms recognize the value of Acceleronâ€™s rich pipeline and unparalleled expertise in developing these novel therapiesâ€ said John Knopf, Ph.D., Chief Executive Officer of Acceleron. â€œThe company has made enormous progress and this financing will enable us to continue to advance our lead programs through later-stage clinical studies.â€

â€œBessemer Venture Partners invests in biopharmaceutical companies pursuing high-potential novel drugs. Acceleron is creating an extremely promising pipeline of products led by the programs for bone and muscle growth,â€ said Christopher Gabrielli, senior partner at Bessemer Venture Partners. â€œWe are delighted to invest in Acceleron and join an experienced and proven management team along with a very strong and committed group of investors.â€

In connection with the financing, Acceleron has reorganized its expanding Board of Directors, which is comprised of Tony Evnin (Venrock), L. Patrick Gage, Ph.D. (PDL), Jean George (ATV), Carl Gordon, Ph.D. (OrbiMed), Ed Kania (Flagship), John Knopf, Ph.D. (Acceleron), Tom Maniatis, Ph.D. (Harvard), Terry McGuire (Polaris), Richard Pops (Alkermes), and Wylie Vale, Ph.D. (Salk). Richard Pops has been elected Lead Director.

â€œAcceleronâ€˜s unique product platform has led to the internal generation of a robust pipeline of promising therapeutic candidates that modulate growth and repair of bone, muscle and other tissues. Clinical candidates are already in development and we expect at least one new product to progress into the clinic each year for the next several years,â€ commented Richard Pops, Chairman of Alkermes and Lead Director of Acceleronâ€™s Board of Directors. â€œIt has been a pleasure to work with the talented and productive team at Acceleron, and we all look forward to continued progress in exploiting the potential of these novel proteins.â€

About Acceleron Pharma

Acceleron is a privately held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel biotherapeutics that modulate the growth of bone, muscle, fat and the vasculature to treat musculoskeletal, metabolic and cancer-related diseases. Acceleronâ€™s scientific approach takes advantage of its unique insight into the regenerative powers of two protein families: the Growth and Differentiation Factors (GDFs) and Bone Morphogenetic Proteins (BMPs). ACE-011, a novel bone forming agent, is the companyâ€™s lead program, and is being developed to reverse bone loss in diseases such as cancer-related bone loss. 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 companyâ€™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.

Contact: Steven Ertel, Vice President, Corporate Development, Acceleron Pharma, tel: 617-520-1334 and Paul Kidwell (Media) Suda Communications LLC, tel: 617-296-3854.

PRESS RELEASE: Acceleron Appoints John Knopf to CEO Spot

Maureen Martino — Tue, 18 Sep 2007 13:14:26 -0400

Acceleron Appoints John Knopf to CEO Spot

CAMBRIDGE, MA - September 18, 2007 - Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced that John L. Knopf, Ph.D., has been named as the Chief Executive Officer of Acceleron. Dr. Knopf has also been elected to the Company's Board of Directors. Dr. Knopf, a founder of Acceleron, has served as the Executive Vice President of Corporate Development and recently, as President, before being unanimously elected by the Board as the Company's next CEO.

"John has been an instrumental leader at Acceleron since founding the Company. His keen insight into the scientific and clinical potential of Acceleron's R&D platform generates tremendous long-term value for the Company," said Richard Pops, a member of Acceleron's Board of Directors. "We are extremely pleased to leverage John's scientific acumen and business vision in his role as CEO."

"I am thrilled to lead Acceleron though its next stages of growth," said Dr. Knopf. "Acceleron is uniquely poised for continued success with the results of the ACE-011 phase 1 study being announced later today and efforts already underway to initiate phase 2 studies with ACE-011 later this year. We are also working diligently to bring ACE-031, our compound to increase muscle mass and strength, into the clinic in early 2008."

Prior to co-founding Acceleron, Dr. Knopf was formerly Site Head of the Wyeth Research facilities in Cambridge, MA and Vice President of Metabolic and Respiratory Disease until 2002. Dr. Knopf was a key scientist at Genetics Institute from 1982 to 1998, where he participated in the development of pioneering biopharmaceutical products and helped establish Genetics Institute as a premier biopharmaceutical company. He also established a structure-based small molecule discovery group at Genetics Institute. Dr. Knopf is the author of several key scientific manuscripts in the area of signal transduction and of a number of patents. He received his Ph.D. from SUNY Buffalo and his B.S. from SUNY Stonybrook.

About Acceleron Pharma

Acceleron is a privately held biopharmaceutical company committed to discover, develop, manufacture and commercialize novel biotherapeutics that modulate the growth of bone, muscle, 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 two protein families: the Growth and Differentiation Factors (GDFs) and Bone Morphogenetic Proteins (BMPs). ACE-011, an anabolic bone agent, is the company's lead program, and is being developed to reverse bone loss in diseases such as cancer-related bone loss and osteoporosis. In addition, the company is advancing through preclinical development with 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, Flagship Ventures, OrbiMed Advisors, Polaris Ventures, Sutter Hill Ventures and Venrock.

Contact: Steven Ertel, Vice President, Corporate Development, Acceleron Pharma, tel: 617-520-1334 and Paul Kidwell (Media) Suda Communications, tel: 617-296-3854.