Array, Novartis ink agreement for encorafenib
BOULDER, Colo.—Biopharmaceutical company Array BioPharma Inc. has announced the signing of a definitive agreement under which it will acquire worldwide rights to encorafenib (LGX818) from Novartis Pharma AG. The compound is a BRAF inhibitor currently in Phase 3 development and under investigation in multiple cancer types. This deal is conditional on the closing of transactions Novartis announced with GlaxoSmithKline plc in April 2014, which are expected to close in the first half of this year. Array previously announced a definitive agreement with Novartis to regain global rights to binimetinib, a Phase 3 MEK inhibitor, and to address competition concerns from the European Commission, Array will obtain an experienced global partner for the global development and European commercialization of binimetinib and encorafenib.
Novartis will make a de-minimis payment to Array, and has agreed to provide transitional regulatory, clinical development and manufacturing services to Array. The company will assign or license to Array all patent and other intellectual property rights to the extent relating to encorafenib. Novartis has agreed to conduct and fund the COLUMBUS trial through either June 30, 2016 or the completion of last patient first visit, whichever comes first. At that point, Array will assume full responsibility for the trial, with Novartis reimbursing Array for out-of-pocket costs along with 50 percent of Array's full-time equivalent costs in connection with completing the COLUMBUS trial. Novartis will be responsible for conducting all other encorafenib trials until their completion or transfer to Array for a defined transition period. For all trials transferred to Array, Novartis will reimburse Array for out-of-pocket costs and 50 percent of the latter's full-time equivalent costs in connection with completing the trials.
“Acquiring worldwide rights to encorafenib, an innovative late-stage oncology product, represents a tremendous opportunity for Array," Ron Squarer, CEO of Array BioPharma, commented in a statement. "There are currently 11 active encorafenib clinical trials, including the Phase 3 COLUMBUS trial, in which encorafenib is being studied in combination with binimetinib for BRAF+ melanoma patients. With rights to both encorafenib and binimetinib, Array would enhance its position to broadly develop and commercialize each product, as well as this MEK/BRAF combination, which may have differentiating advantages when compared to available therapies."
Novartis will supply encorafenib for clinical and commercial use for up to 30 months after the deal's closing and will provide assistance in the technology and manufacturing transfer of encorafenib. The company will also provide Array with ongoing access to several of its pipeline compounds for use in ongoing combination studies with encorafenib, as well as possible future studies.
SOURCE: Array BioPharma Inc.