Array BioPharma announced an agreement to regain full rights from Novartis to the experimental MEK inhibitor binimetinib. Array, whose shares jumped as much as 25 percent on the news, noted that the deal is conditional on the closing of transactions announced earlier this year by Novartis and GlaxoSmithKline, which are expected in the first half of 2015.
In 2010, Novartis licensed exclusive global rights from Array to develop and commercialise binimetinib as part of a transaction valued at up to $467 million. Array indicated that the deal will be terminated and superseded by a new set of agreements between the companies, which will include an upfront payment from Novartis of up to $85 million.
"Regaining full worldwide rights to binimetinib...represents a tremendous opportunity," remarked Array CEO Ron Squarer. The executive noted that the drug "is currently advancing in three Phase III clinical trials," adding "we expect to file for our first regulatory approval during the first half of 2016." Late-stage studies of binimetinib include NEMO in NRAS-mutant melanoma, MILO for low-grade serous ovarian cancer and COLUMBUS in BRAF-mutant melanoma.
According to Array, Novartis has agreed to conduct or substantially fund all ongoing and several planned clinical studies, including COLUMBUS, NEMO and MILO. In addition, the Swiss drugmaker will remain responsible for conducting and funding development of a NRAS melanoma companion diagnostic until FDA premarket approval is received. Further, Array said that Novartis will continue to supply binimetinib for all clinical and commercial needs for up to 30 months after closing and will also assist in the technology and manufacturing transfer of the drug.
Under its agreement with GlaxoSmithKline, Novartis will acquire a portfolio of oncology products from the UK company, including the MEK inhibitor Mekinist (trametinib), for $14.5 billion, as well as up to $1.5 billion in milestone payments.
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