New Celgene, Acceleron agreement to target anemia
SUMMIT, N.J. & CAMBRIDGE, Mass.—Celgene Corporation and Acceleron Pharma, Inc., a biopharmaceutical company specializing in protein therapeutics for orphan diseases and cancer, have entered into a joint development and commercialization agreement for ACE-536 for the treatment of anemia. Under the agreement, the two companies will jointly develop, manufacture and commercialize ACE-536 for the treatment of anemia. Acceleron will receive an upfront payment to Acceleron of $25 million, and Celgene will have an option to future Acceleron programs that are developed for anemia.
Celgene and Acceleron have a previous collaboration in place around ACE-011, sotatercept, which they entered into in 2008. As per the terms of the new agreement, the two companies will collaborate on the development of both products and, potentially, others for the treatment of anemia across a 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," John Knopf, Ph.D., Chief Executive Officer of Acceleron, said in a press release about the agreement. "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 I clinical trial of ACE-536 within the next few months. ACE-536 is our fourth internally discovered and developed drug to enter the clinic."
Under the agreement, Acceleron will be in charge of conducting the Phase I and initial Phase II clinical trials, and will manufacture ACE-536 for those trials. Celgene will take over for the subsequent Phase II and Phase III clinical studies, and will be in charge of the manufacture of Phase III as well as commercial supplies. The companies will share development costs as well, with Acceleron paying a share of the expenses through the end of 2012 and Celgene taking responsibility for all development costs thereafter. Acceleron is eligible to receive development, regulatory and commercial milestones of up to $217 million for the ACE-536 program, and will also receive double-digit royalties on worldwide net sales. Acceleron and Celgene will co-promote the products in North America.
ACE-536 is a novel protein therapeutic that works by inhibiting members of the TGF-beta superfamily involved in erythropoiesis, or the production of red blood cells. In preclinical studies, it was shown to promote the formation of red blood cells in the absence of erythropoietin signaling, to have different effects on red blood cell differentiation compared to erythropoietin and acts on a different population of progenitor blood cells than erythropoietin during the development of red blood cells.
Sotatercept is a soluble receptor fusion protein comprised of extracellular domain of the human activin receptor type IIA (ActRIIA) fused to human immunoglobulin, according to Acceleron. Blocking signaling through ActRIIA has potential as another mechanism by which to increase red blood cell production, promote bone growth and inhibit tumor growth and metastasis. Sotatercept is currently in Phase II clinical trials in patients suffering from chemotherapy-induced anemia, as well as in patients with end-stage renal disease on hemodialysis.
"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 of Research at Celgene, in a press release. "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."
SOURCE: Acceleron Pharma, Inc. press release