Array BioPharma and Pierre Fabre are collaborating to globally develop and commercialize Array’s late-stage novel oncology products binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, currently are advancing in three global phase III trials for melanoma and ovarian cancer. Top-line results from NEMO, a phase III study of binimetinib in patients with NRAS-mutant melanoma, are anticipated before the end of 2015.
Array will receive an upfront payment of $30 million and retains exclusive commercialization rights for binimetinib and encorafenib in the U.S., Canada, Japan, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future development costs on a 60/40 basis (Array/Pierre Fabre) with initial funding committed for new clinical trials in colorectal cancer and melanoma. All ongoing binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.
“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,” said Array BioPharma CEO Ron Squarer. “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.”
The agreement remains subject to European Commission on Competition review and approval.