Undeterred by a recent late-stage setback for Array BioPharma's late-stage melanoma candidate binimetinib, Japan's Ono Pharma has stumped up $31.6 million for Japanese and South Korean rights to the drug and partner compound encorafenib.
And Array says it could claim another $156 million from Ono if MEK inhibitor binimetinib and BRAF-targeting encorafenib—currently in two phase 3 trials in colorectal cancer—meet development and commercial objectives including a positive outcome in an ongoing phase 3 trial (BEACON) in colorectal cancer.
"In Ono, we selected a market leader in immuno-oncology with a rapidly growing product portfolio and recent track record of successful development and commercialization in Japan," said Array's CEO Ron Squarer, adding that the deal "allows us to remain focused on commercializing binimetinib and encorafenib in the U.S.."
Last month, Array was forced to withdraw a marketing application for binimetinib in the virulent NRAS-mutant form of melanoma after the FDA said its main trial in support of the monotherapy wasn't up to scratch. That news followed a failed trial of binimetinib on its own in ovarian cancer.
The NRAS melanoma disappointment was deemed minor by analysts at Leerink who said this form of skin cancer is rare and the drug has much more potential in other indications, although they added it was "a clear setback for the company and management’s regulatory and commercial strategy."
In addition to BEACON, the combo is also in a phase 3 trial—called COLUMBUS—in patients with BRAF-mutant melanoma that us due to report data in the coming weeks.
The new licensing deal will go some way to restore confidence in the prospects for binimetinib and its partner drug as it plays catch-up with MEK/BRAF combinations marketed by Novartis and Roche for melanoma.
A couple of years ago, Array lost Novartis as its worldwide marketing partner for binimetinib and encorafenib, with the Swiss group exiting a $467 million deal for the drugs—after shelling out $60 million—as it focused instead on MEK inhibitor Mekinist and BRAF inhibitor Tafinlar that it had just acquired from GlaxoSmithKline.
At the time, Array stuck to the usual line that this was an opportunity to take the drugs forward on its own, an idea which gained credence after it promptly signed a $455 million deal with Pierre Fabre for European rights to the binimetinib/encorafenib combo.
The two partnerships now exceed the value of the earlier Novartis deal for binimetinib, with Array still retaining its rights in the U.S. and other world markets. Investors certainly seemed to like the news, with the company's share price up more than 6% in premarket trading.