New Celgene, Acceleron agreement to target anemia

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.

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SUMMIT, N.J. & CAMBRIDGE, Mass.—Celgene Corporation andAcceleron Pharma, Inc., a biopharmaceutical company specializing in proteintherapeutics for orphan diseases and cancer, have entered into a jointdevelopment and commercialization agreement for ACE-536 for the treatment ofanemia. Under the agreement, the two companies will jointly develop,manufacture and commercialize ACE-536 for the treatment of anemia. Acceleronwill receive an upfront payment to Acceleron of $25 million, and Celgene willhave an option to future Acceleron programs that are developed for anemia.
Celgene and Acceleron have a previous collaboration in placearound ACE-011, sotatercept, which they entered into in 2008. As per the termsof the new agreement, the two companies will collaborate on the development ofboth products and, potentially, others for the treatment of anemia across arange of indications.
"Acceleron has uncovered an exciting new approach totreating disorders of erythropoiesis, and we are pleased to broaden oursuccessful partnership with Celgene," John Knopf, Ph.D., Chief ExecutiveOfficer of Acceleron, said in a press release about the agreement. "Acceleronand Celgene can now combine our strengths to develop molecules to treat a broadarray of under-served diseases and conditions in which patients suffer fromanemia. To that end, we look forward to initiating the Phase I clinical trialof ACE-536 within the next few months. ACE-536 is our fourth internallydiscovered and developed drug to enter the clinic."
Under the agreement, Acceleron will be in charge ofconducting the Phase I and initial Phase II clinical trials, and willmanufacture ACE-536 for those trials. Celgene will take over for the subsequentPhase II and Phase III clinical studies, and will be in charge of themanufacture of Phase III as well as commercial supplies. The companies willshare development costs as well, with Acceleron paying a share of the expensesthrough the end of 2012 and Celgene taking responsibility for all developmentcosts thereafter. Acceleron is eligible to receive development, regulatory andcommercial milestones of up to $217 million for the ACE-536 program, and willalso receive double-digit royalties on worldwide net sales. Acceleron andCelgene will co-promote the products in North America.
ACE-536 is a novel protein therapeutic that works byinhibiting members of the TGF-beta superfamily involved in erythropoiesis, orthe production of red blood cells. In preclinical studies, it was shown topromote the formation of red blood cells in the absence of erythropoietinsignaling, to have different effects on red blood cell differentiation comparedto erythropoietin and acts on a different population of progenitor blood cellsthan erythropoietin during the development of red blood cells.
Sotatercept is a soluble receptor fusion protein comprisedof extracellular domain of the human activin receptor type IIA (ActRIIA) fusedto human immunoglobulin, according to Acceleron. Blocking signaling throughActRIIA has potential as another mechanism by which to increase red blood cellproduction, promote bone growth and inhibit tumor growth and metastasis.Sotatercept is currently in Phase II clinical trials in patients suffering fromchemotherapy-induced anemia, as well as in patients with end-stage renaldisease on hemodialysis.
"Celgene and Acceleron have a strong partnership thatcontinues to advance innovative therapies in areas of great unmet medicalneed," said Tom Daniel, Ph.D., President of Research at Celgene, in a pressrelease. "The work we will embark on with ACE-536 is a natural extension of ourstrong presence in hematology. We look forward to exploring the potential ofACE-536 for patients with anemia worldwide."
SOURCE: Acceleron Pharma, Inc. press release

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