Acceleron Pharma and Celgene 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 super family 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.
Under the terms of the agreement, Acceleron will be responsible for conducting the phase I and initial phase II clinical trials and Celgene will conduct the subsequent phase II and phase III clinical studies. Acceleron will manufacture ACE-536 for the phase I and phase II clinical trials and Celgene will have responsibility for the manufacture of phase III 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.