OncoMed Pharmaceuticals and Celgene have inked an agreement to jointly develop and commercialize up to six anti-cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab.
OncoMed will control and conduct initial clinical studies, at which point Celgene has an option to license worldwide rights to up to six novel anti-CSC therapeutic candidates. OncoMed retains global co-development and U.S. co-commercialization rights for five of the six anti-CSC product candidates with equal U.S. profit sharing, and royalties to be received in other territories. Celgene also will have research, development and commercialization rights to small molecule compounds in an undisclosed cancer stem cell pathway.
Celgene obtains an exclusive option on demcizumab during or after completion of certain future planned phase II clinical trials to be conducted by OncoMed. Demcizumab currently is in three phase Ib clinical studies in combination with standard-of-care therapeutics, including a trial in patients with first-line advanced pancreatic cancer. Subsequent to option exercise, the parties will co-develop demcizumab, sharing global development costs on a one-third OncoMed and two-thirds Celgene basis. The companies will co-commercialize demcizumab in the U.S. with an equally split profit sharing. Outside the U.S., Celgene would lead development and commercialization, with OncoMed eligible to receive milestones and tiered double-digit royalties on sales.
In addition to demcizumab, the collaboration includes up to five preclinical- or discovery-stage biologics programs: OncoMed's anti-DLL4/VEGF bispecific antibody and up to four additional biologics programs targeting either the RSPO-LGR CSC pathway or an additional undisclosed CSC pathway.
OncoMed will receive an upfront payment of $155 million, and Celgene also will purchase approximately $22.25 million in a private placement of newly issued shares of OncoMed's common stock at a price of $15.13 per share.
The collaboration also includes option exercise payments and payments for achievement of development, regulatory and commercial milestones, paid on a per-program basis. For demcizumab, these payments could total up to approximately $790 million, and include an undisclosed payment for achievement of pre-determined safety criteria in phase II clinical trials. For the anti-DLL4/VEGF bispecific antibody, option exercise, development, regulatory and commercial payments could total up to $505 million. For the other four biologics, each program is eligible for approximately $440 million of option exercise, development, regulatory and commercial payments.
OncoMed also could receive more than $100 million in option exercise, development and regulatory approval payments for the small molecule program. Such total payments include milestones for regulatory approvals in multiple indications per program. OncoMed retains worldwide rights to certain targets in multiple pathways that do not become collaboration programs with Celgene.
Tom Daniel, president, global research and early development, Celgene, said, "Demcizumab's substantial early clinical activity warrants aggressive yet careful evaluation in several indications where we have strength, including non-small cell lung cancer and pancreatic cancer."