Array Takes Back Rights To Binimetinib From Novartis
Array BioPharma, a biopharmaceutical firm focused on developing targeted small molecule drugs against cancer, announced that it has agreed to regain full global rights to its investigational drug binimetinib from Novartis.
Binimetinib is a small-molecule MEK inhibitor in the RAS/RAF/MEK/ERK pathway, which plays a regulatory role in key cellular activities. Misuse of this pathway has been observed in several cancers through mutations in NRAS, KRAS, and BRAF. The drug is currently undergoing three Phase 3 trials in advanced cancers, namely NRAS-mutant melanoma, low-grade serous ovarian cancer, and BRAF-mutant melanoma.
Novartis has previously bought the global, exclusive rights to develop and market binimetinib in 2010. The original agreement will be terminated and replaced with a new set of agreements between Array and Novartis. Array will receive up to $85 million from Novartis and will regain rights to binimetinib. Novartis has agreed to supply transitional regulatory, clinical development, and manufacturing capabilities in the meantime. The company will continue to provide access to its pipeline compounds for use in ongoing studies as well as future studies to investigate possible combination treatments with binimetinib.
Ron Squarer, CEO of Array BioPharma, viewed the transaction as a great opportunity for the company. “Binimetinib is currently advancing in three Phase 3 clinical trials and, we expect to file for our first regulatory approval during the first half of 2016. With this agreement, we are in a strong position to successfully develop and commercialize binimetinib to the benefit of cancer patients.”
Novartis said, “Binimetinib has demonstrated promising results for cancer patients across several different clinical trials. We are committed to supporting a successful transition to Array.” In September, the partners reported positive results from the Phase 2 trial of the drug in NRAS melanoma.
Array said that the agreement hinges on the completion of the transactions between Novartis and GlaxoSmithKline, expected to close in the first half of 2015.