Array Biopharma and Pierre Fabre announce development and commercialization collaboration for two novel oncology products, binimetinib and encorafenib
16 November 2015
Array to receive a $30 million up-front payment and up to $425 million in additional development and commercialization milestones, as well as robust double-digit royalties on future sales
Array retains full commercialization rights to binimetinib and encorafenib in United States, Canada, Japan and Korea
NEMO Phase 3 trial remains on-track for top-line results by end of 2015
Array to host conference call November 16, 2015 at 9:00 am Eastern Time
Boulder, Colo. (November 16, 2015) – Array BioPharma Inc. (Nasdaq: ARRY) and Pierre Fabre today announced a collaboration to globally develop and commercialize Array’s late-stage novel oncology products, binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently advancing in three, global Phase 3 trials for melanoma and ovarian cancer. Top-line results from NEMO, a Phase 3 study of binimetinib in patients with NRAS-mutant melanoma, are anticipated before the end of 2015. Array plans to host a conference call on November 16, 2015 at 9:00 am ET to discuss the collaboration.
Under the terms of the agreement, Array will receive an upfront payment of $30 million and retains exclusive commercialization rights for binimetinib and encorafenib in the United States, 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.
Pierre Fabre Oncology, a business unit of the global 10,000-employee Pierre Fabre Company, is supported by over 1,000 employees with a strong focus on European markets. In 2014, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and track record in pharmaceutical R&D, developing products for patients afflicted 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,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “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.”
Pierre Fabre is strongly committed to develop and commercialize oncology products,” said Frederic Duchesne, Chief Executive Officer, 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.
The agreement remains subject to European Commission on Competition review and approval.
CONFERENCE CALL INFORMATION
Array will hold a conference call on Wednesday, November 16, 2015 at 9:00 a.m. Eastern Time to discuss these results. Ron Squarer, Chief Executive Officer will lead the call.
Date: Monday, November 16, 2015
Time: 9:00 a.m. Eastern Time Toll-Free: (844) 464-3927
Toll: (765) 507-2598
Pass Code: 80617598
Webcast, including Replay and Conference Call Slides:
About Binimetinib and Encorafenib
RAF and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway. Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Three Phase 3 trials in advanced cancer patients continue to advance: NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). NRAS- mutant melanoma represents the first potential indication for binimetinib, with a projected regulatory filing estimated in the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016.
Press Contact :
Valérie Roucoules - 01 49 10 83 84