Array BioPharma said today it will globally develop and commercialize two pivotal-phase oncology candidates it acquired from Novartis earlier this year through a newly launched collaboration with Pierre Fabre. The alliance could generate up to $455 million for Array.
The deal covers the MEK inhibitor binimetinib, and the BRAF inhibitor encorafenib. Both are currently in three global Phase III trials for melanoma and ovarian cancer. Array said top-line results from NEMO, a Phase III study of binimetinib in patients with NRAS-mutant melanoma, are anticipated before year’s end.
Under the deal, Array will retain exclusive commercialization rights for binimetinib and encorafenib in the U.S., as well as Canada, Japan, Korea, and Israel. Pierre Fabre will have exclusive rights to commercialize both products elsewhere in the world—including Europe, Asia, and Latin America.
Pierre Fabre agreed to pay Array $30 million upfront, and up to $425 million in payments tied to achieving development and commercialization milestones.
Array is also eligible for tiered double-digit royalties tied to sales, with the company agreeing to shoulder 60% of future development costs, and Pierre Fabre assuming the other 40%. Initial funding has been committed for new clinical trials in colorectal cancer and melanoma, Array said.
All ongoing binimetinib and encorafenib clinical trials remain “substantially” funded through completion by Novartis, Array added. In March, Array agreed to acquire the cancer compounds from Novartis, receiving $85 million upfront. Novartis was required to sell off the drugs by the U.S. Federal Trade Commission in return for the agency’s approval of the pharma giant’s acquisition of GlaxoSmithKline (GSK)’s cancer business.
Array said the two compounds would be developed by the French drug developer’s Pierre Fabre Oncology unit, which generated $200 million in global sales last year, anchored by its Oral Navelbine, Javlor and Busilvex brands. Pierre Fabre Oncology specializes in developing products for patients with lung, breast, and other solid tumors and hematological cancers.
“In Pierre Fabre we selected a partner with a European and emerging market focus in oncology to develop and commercialize binimetinib and encorafenib in these geographies,” Array CEO Ron Squarer said in a statement. “With Phase III trials approaching data readouts, and over 30 additional Phase I/II trials underway, we are confident that binimetinib and encorafenib are well positioned for near-term regulatory submissions and significant commercial value.”
Earlier this year, Squarer stated that Array planned to file regulatory submissions for marketing approvals for the cancer compounds in 2016.
Frederic Duchesne, CEO of Pierre Fabre Pharmaceuticals, added that the partnership with Array was aligned with his company’s growth strategy in pharmaceuticals, our geographic footprint, and its corporate mission to bring to market novel oncology products that address unmet patient needs.
“Binimetinib and encorafenib will fit perfectly with our broad expertise in oncology and dermatology, and will strengthen our current portfolio and international presence,” Duchesne said.