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.
“Acceleron has uncovered an exciting new approach to treating disorders of erythropoiesis, and we are pleased to broaden our successful partnership with Celgene”
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.
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