Array BioPharma Inc., based in Colorado, and Pierre Fabre of France have recently announced they will collaborate on the development and commercialization of novel oncology products for the treatment of melanoma and ovarian cancer. The global collaboration focuses on Array’s late-stage products, binimetinib and encorafenib, and the company plans on presenting results from its NEMO study of binimetinib in patients with NRAS-mutant melanoma by year’s end.
Under the agreement, Array will receive a $30 million upfront payment and retain exclusive commercialization rights for binimetinib and encorafenib in the United States, Canada, Japan, Korea, and Israel. Pierre Fabre will hold exclusive rights to both products in all other countries. Array is eligible to receive up to $425 million for certain development and commercialization milestones and tiered double-digit royalties on future sales. Array and Pierre Fabre will share future development costs, on a 60:40 basis, respectively, with initial funding going to support new clinical trials in melanoma and colorectal cancer. The agreement awaits the review and approval of the European Commission on Competition.
“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 Ron Squarer, Chief Executive Officer at Array BioPharma, in a company press release. “With Phase 3 trials approaching data readouts, and over 30 additional Phase 1/2 trials underway, we are confident that binimetinib and encorafenib are well positioned for near-term regulatory submissions and significant commercial value.”
Binimetinib is a MEK inhibitor while encorafenib is a BRAF inhibitor, both key protein kinases in the RAS/RAF/MEK/ERK pathway. Mutations in the BRAF, KRAS and NRAS genes are common in many types of cancer and lead to abnormal activation patterns of that pathway. Array is focused on the potential of these therapies, with three Phase 3 trials currently being conducted in advanced cancer patients: NEMO evaluating the use of binimetinib in NRAS-mutant melanoma, COLUMBUS evaluated binimetinib and encorafenib to treat patients with BRAF-mutant melanoma, and MILO assessing binimetinib in low-grade serous ovarian cancer patients. NRAS-mutant melanoma is the first expected indication for binimetinib, with a projected regulatory filing set for the first half of 2016.
“Pierre Fabre is strongly committed to develop and commercialize oncology products,” said Frederic Duchesne, the Chief Executive Officer at Pierre Fabre Pharmaceuticals. “This partnership with Array is aligned with our growth strategy in Pharmaceuticals, our geographic footprint, and our corporate mission to bring to the market novel oncology products which 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.”
Binimetinib was licensed to Novartis, but Array late last year regained full rights to what it considers a promising late-stage cancer therapy. In December, Array BioPharma reached a conclusive agreement with Novartis allowing it to recover complete worldwide rights to binimetinib, after the termination of transactions were announced by Novartis and GlaxoSmithKline.