Array BioPharma, Inc. Regains Worldwide Rights To Cancer Drug From Novartis AG

December 4, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Array BioPharma, Inc. announced on Dec. 3 that it had regained worldwide rights to binimetinib, a MEK inhibitor, from Novartis International Pharmaceutical Ltd. As a result, Novartis will pay Array up to $85 million upfront.

Previously, Array had given Novartis the worldwide exclusive rights to the drug, which has been used in Phase 3 trials. This agreement was created in 2010, but it will now be terminated under the new deal.

"Regaining full worldwide rights to binimetinib, an innovative late-stage oncology product, represents a tremendous opportunity for Array," said Ron Squarer, chief executive officer of Array BioPharma. "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."

Binimetinib is a MEK inhibitor, which is currently undergoing a number of trials. MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway, responsible for regulating several cellular activities within the body. However, inappropriate activation of this pathway has shown up in many cancers. Binimetinib works by targeting a particular enzyme within the pathway.

Currently, patients are being enrolled in three Phase 3 trials using the drug. Binimetinib is being looked at for the treatment of NRAS-mutant melanoma, low-grade serous ovarian cancer and BRAF-mutant melanoma.

Clinical trials that are focused on the drug, including COLUMBUS, NEMO and MILO, will continue as planned. Novartis will be responsible for the conduct and funding of the COLUMBUS trial. The company will also reimburse Array for all remaining out-of-pocket expenses and half of all remaining fully burdened FTE costs required to complete the trials.

"Binimetinib has demonstrated promising results for cancer patients across several different clinical trials,” Novartis said in a statement. “We are committed to supporting a successful transition to Array."

Novartis is also responsible for funding the development of the NRAS melanoma companion diagnostic until the drug receives premarket approval from the U.S. Food and Drug Administration.

Array will receive assistance from Novartis in the technology and manufacturing of binimetinib. The company will also have access to Novartis pipeline compounds as needed for future studies.