Array BioPharma Inc. has announced it reached a conclusive agreement with Novartis allowing it to recover complete worldwide rights to binimetinib, a MEK inhibitor currently being investigated in three Phase 3 clinical trials.
This agreement is dependent on the termination of transactions announced by Novartis and GlaxoSmithKline PLC (GSK) earlier this year, which should be concluded in the beginning of 2015.
Array had already granted Novartis sole worldwide rights for the research and commercialization of binimetinib, which will be replaced by a new set of arrangements between both companies.
Binimetinib is a small-molecule MEK inhibitor, a key protein kinase in the RAS/RAF/MEK/ERK pathway, essential for multiple aspects of cancer progression. MEK is responsible for the regulation of different cellular aspects including proliferation, differentiation, migration, survival and angiogenesis. Mutations in the BRAF, KRAS and NRAS genes are common in many types of cancer, including melanoma, and lead to abnormal activation patterns of the RAS/RAF/MEK/ERK pathway.
15 to 25% of melanoma patients carry NRAS mutations, transforming it into a more severe form of skin cancer with an associated median overall survival of only 8.2 months.
“Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array,” Ron Squarer, Chief Executive Officer, Array BioPharma said in a press release. “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.”
There are currently three Phase 3 clinical trials which continue to enroll patients, to assess the efficacy and safety of binimetinib in advanced cancer patients — low-grade serous ovarian cancer (MILO), BRAF-mutant melanoma (COLUMBUS) and NRAS-mutant melanoma (NEMO), which has been specifically designed to investigate the difference in progression-free survival between patients treated with binimetinib versus those treated with dacarbazine, a chemotherapy drug commonly used to treat malignant melanoma.
“Binimetinib has demonstrated promising results for cancer patients across several different clinical trials. We are committed to supporting a successful transition to Array”, Novartis stated in the press release.