Deal for Phase I drug and three discovery-stage compounds could ultimately be worth over $1.8 billion.
Celgene agreed to help Acceleron Pharma advance some of its bone loss products in a deal worth upto $1.87 billion. Since the collaboration includes an early-stage compound and three discovery programs, Acceleron will not see most of the money for a while if at all.
The company will, however, receive $50 million upfront, which includes a $5 million equity investment. In addition, in the event of an IPO of Acceleron, Celgene will purchase a minimum of $7 million worth of Acceleron common stock.
The deal covers Acceleron’s potential first-in-class bone-forming compound. ACE-011, a protein therapeutic based on the activin receptor type IIA, is in an early-stage trial. The agreement also includes an option for certain discovery-stage programs.
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.
Acceleron will retain responsibility for initial activities including research, development through the end of Phase IIa trials, and manufacturing the clinical supplies for these studies. In turn, Celgene will conduct Phase IIb and Phase III trials and will oversee the manufacture of Phase III 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 copromote the products in North America. Acceleron will receive tiered royalties on worldwide net sales. “This collaboration is an excellent strategic fit for Acceleron and the ACE-011 program,” said John Knopf, Ph.D., CEO 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.”
In preclinical models of bone loss, ACE-011 increased bone mineral density, improved bone architecture, increased the mineral apposition and bone formation rates, and improved bone mechanical strength, according to Acceleron. In its Phase I study, ACE-011 demonstrated an encouraging safety profile and increased biomarkers of bone formation. ACE-011 is currently in a Phase Ib study, and Acceleron expects to begin a Phase IIa study in multiple myeloma in the middle of 2008.