Array BioPharma Inc. ARRY entered into a collaboration agreement with Pierre Fabre, a privately-owned French company, for the worldwide development and commercialization of its late-stage oncology candidates, binimetinib and encorafenib.
Binimetinib, a MEK inhibitor, is currently being evaluated in two phase III studies – NEMO for the treatment of patients with NRAS-mutant melanoma and MILO for the treatment of patients with low-grade serous ovarian cancer. Top-line results from NEMO and MILO are expected by the end of 2015 and in 2017, respectively.
Binimetinib is also being evaluated in combination with encorafenib, a BRAF inhibitor, in the phase III COLUMBUS study for the treatment of patients with BRAF-mutant melanoma. Top-line results are expected in the first half of 2016.
A regulatory filing for binimetinib for the treatment of NRAS-mutant melanoma is projected in the first half of 2016 and for the binimetinib – encorafenib combination for the treatment of BRAF melanoma in 2016. The company also projects a regulatory filing for binimetinib for the treatment of low-grade serous ovarian cancer in 2017.
Terms of the Agreement
Pierre Fabre will make an upfront payment of $30 million to Array BioPharma. In addition, Array BioPharma is entitled to receive up to $425 million on the achievement of development and commercialization milestones and tiered double-digit royalties on future sales. While Array BioPharma holds exclusive rights to commercialize the candidates in the U.S., Canada, Japan, Korea and Israel, Pierre Fabre has the rights to commercialize the candidates in all other countries, including the EU, Asia and Latin America.
Moreover, both companies have agreed to split future costs related to the development of the candidates in new clinical studies for colorectal cancer and melanoma, with 60% of the costs funded by Array BioPharma and the remaining by Pierre Fabre.
We remind investors that in Mar 2015, Array BioPharma had regained rights to develop and commercialize binimetinib, and also acquired rights to develop and commercialize encorafenib from Novartis AG NVS. However, Novartis is still responsible to fund a substantial part of the ongoing phase III studies till their completion.
Array BioPharma carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and Achillion Pharmaceuticals, Inc. ACHN, both sporting a Zacks Rank #1 (Strong Buy).
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