Acceleron Pharma, Inc. and Celgene Corporation have announced a worldwide strategic collaboration for the joint development and commercialization of ACE-011, a first-in-class, novel bone-forming compound.
The collaboration combines both companies’ resources and commitment to developing products for the treatment of cancer and cancer-related bone loss.
In pre-clinical and early clinical studies, this innovative compound has reported success in key biomarkers of bone formation. The companies also signed an option agreement for certain discovery stage programs.
Under the terms of the agreement, Celgene and Acceleron will jointly develop, manufacture and commercialize Acceleron’s products for bone loss. Celgene will make an upfront payment to Acceleron of $50 million, which includes 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.
“This collaboration is an excellent strategic fit for Acceleron and the ACE-011 program. Celgene is one of the most successful biotech companies in the world and is the leader in the field of blood cancers, including multiple myeloma, an indication where ACE-011 has great potential,” said John Knopf, Ph.D., Chief Executive Officer of Acceleron.
“We believe Celgene’s established commercial, clinical, regulatory and international capabilities complemented by Acceleron’s expertise in novel biologics drug discovery, manufacturing and development may result in a successful partnership that reflects a shared vision to improve the lives of patients worldwide,” Knopf continued.
Acceleron will retain responsibility 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. The companies will co-promote the products in North America. Acceleron will receive tiered royalties on worldwide net sales.
“Celgene supports the development of promising new approaches for the treatment of cancer and bone loss like ACE-011,” said Sol Barer, Ph.D., Chairman and Chief Executive Officer of Celgene. “We look forward to the initiation of the ACE-011 Phase 2a study in multiple myeloma later this year.”
The completion of the agreement is subject to Hart-Scott-Rodino approval under United States antitrust laws.