OncoMed Pharmaceuticals and Celgene said today they will jointly develop and commercialize up to six anti- cancer stem cell (CSC) product candidates from OncoMed's biologics pipeline, including demcizumab (OMP-21M18, Anti-DLL4). The collaboration could net OncoMed more than $3.3 billion.
In return, Celgene obtains an exclusive option on one of OncoMed's most advanced clinical candidates, demcizumab, during or after the completion of future planned Phase II clinical trials to be conducted by OncoMed. Demcizumab is now in three Phase Ib clinical studies, where it is being assessed in combination with standard-of-care therapeutics, including a trial in patients with first-line advanced pancreatic cancer.
Once Celgene exercises its option on demcizumab, it will join OncoMed in co-developing the compound, shelling out two-thirds of global development costs while Celgene pays the other one-third. The companies will co-commercialize demcizumab in the U.S. with 50/50 profit sharing, while outside the U.S., Celgene would lead development and commercialization, with OncoMed eligible for milestones and tiered double-digit royalties on sales.
“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,” Tom Daniel, president of Celgene’s Global Research & Early Development unit, said in a statement.
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.
“The earlier partnerships in the RSPO-LGR and another, undisclosed cancer stem cell pathway provide us complementary and strategically valuable targeting opportunities across both biologic and small molecule modalities in the cancer stem cell arena,” Daniels said.
Added Paul J. Hastings, OncoMed's chairman and CEO: “By retaining co-development and co-commercialization rights to up to five biologic product candidates in our pipeline, we expect to add commercial capabilities to our core research and development competencies as we continue to build a premier oncology biotherapeutics company."
Celgene will obtain exclusive options on these programs during or after completion of Phase I clinical trials to be conducted by OncoMed. For the anti-DLL4/VEGF bispecific antibody and three of the four additional biologics programs, OncoMed retains 50/50 U.S. profit sharing and co-commercialization, while agreeing to pay one-third of global development cost-sharing and mid-single digit to mid-double digit royalties outside the U.S.; Celgene pays the remaining two-thirds.
For the fourth biologics program, Celgene would receive an exclusive worldwide license, in return for OncoMed obtaining high-single digit to mid-double digit royalties on worldwide sales. Celgene also obtains an option to conduct small molecule research, development, and commercialization in an undisclosed CSC pathway, with OncoMed eligible to receive milestones and low- to mid-single digit royalties on any resulting small molecule anticancer product candidates.
Under their agreement, Celgene will pay OncoMed $155 million up front, then purchase via private placement some $22.25 million in new shares of OncoMed's common stock, at $15.13 per share.
Celgene will also make payments to OncoMed tied to development, regulatory and commercial milestones, with additional milestones payments per program for regulatory approvals in multiple indications:
- For demcizumab, up to approximately $790 million, plus an undisclosed payment for achieving pre-determined safety criteria in Phase II clinical trials.
- For the anti-DLL4/VEGF bispecific antibody, option exercise, up to $505 million in development, regulatory and commercial payments.
- For the other four biologics, each program is eligible for about $440 million of option exercise, development, regulatory and commercial payments.
- For the small molecule program, OncoMed could also receive more than $100 million in option exercise, development and regulatory approval payments.
OncoMed retains worldwide rights to certain targets in multiple pathways that do not become collaboration programs with Celgene, the companies said.