Novartis reached a definitive agreement to sell global rights to the experimental BRAF inhibitor encorafenib to Array BioPharma for an undisclosed sum, the latter announced Friday. Array, whose shares surged more than 36 percent on the news, noted that the deal is subject to the completion of a previously announced asset swap between Novartis and GlaxoSmithKline, which is expected to close in the first half of this year. Array CEO Ron Squarer commented that "acquiring worldwide rights to encorafenib, an innovative late-stage oncology product, represents a tremendous opportunity."
Under the agreed terms, Novartis will provide Array with transitional regulatory, clinical development and manufacturing services, as well as assign all intellectual property rights associated with encorafenib, also known as LGX818, to the company. Specifically, Novartis will conduct and fund the Phase III COLUMBUS trial, which is evaluating encorafenib as monotherapy and in combination with Array's investigational MEK inhibitor binimetinib versus Roche's Zelboraf (vemurafenib) in patients with BRAF V600-mutant melanoma, through to the earlier of either June 30, 2016, or completion of the last patient's first visit, after which Array will assume responsibility.
Novartis will also supply encorafenib to Array for clinical and commercial use for up to 30 months after closing, and provide assistance with the technology and manufacturing transfer of the BRAF inhibitor. Further, the Swiss drugmaker will grant Array continued access to a number of experimental products for use in ongoing combination studies, and possible future studies, with encorafenib.
Meanwhile, to address competition concerns raised by the European Commission, Array said it agreed to identify an"experienced partner" for the global development and European commercialisation of both encorafenib and binimetinib, to which the company recently regained rights from Novartis. "With rights to both encorafenib and binimetinib, Array would enhance its position to broadly develop and commercialise each product, as well as this MEK/BRAF combination, which may have differentiating advantages when compared to available therapies," Squarer said.
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