Exelixis Announces First Regulatory Approval of Cobimetinib in Switzerland

Cobimetinib is a selective inhibitor of MEK that was discovered by Exelixis and is the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group. The trade name for cobimetinib in Switzerland is Cotellic.

Roche’s Swiss regulatory submission for cobimetinib was based on data from coBRIM, the phase 3 pivotal trial of cobimetinib and vemurafenib conducted in 495 patients with previously untreated unresectable, locally advanced or metastatic melanoma with a BRAF V600 mutation.

The resulting approval is the first for cobimetinib worldwide, and additional regulatory applications are under review in other territories. Genentech filed its New Drug Application (NDA) for cobimetinib with the U.S. Food and Drug Administration (FDA) in December 2014 and the Prescription Drug User Fee Act date is November 11, 2015.

Separately, Roche filed a Marketing Authorization Application with the European Medicines Agency in late 2014, and Roche anticipates a regulatory decision before the end of 2015.

"The Swiss regulatory approval of cobimetinib is an important advance for melanoma patients, physicians, and caregivers," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis.

"Exelixis congratulates our partner Roche on this first approval for the product, and we look forward to additional regulatory decisions in the United States and European Union, which are anticipated later this year."

After discovering cobimetinib internally, Exelixis advanced the product to investigational new drug (IND) status. In late 2006, the company entered into its worldwide collaboration with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND.

Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop cobimetinib. Under the terms of the collaboration, Exelixis is eligible to receive royalties on sales of cobimetinib outside the United States.

If cobimeitnib is approved in the United States, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. In November 2013, Exelixis exercised its option to co-promote cobimetinib in the United States and, under the terms of the agreement, the company is prepared to field up to 25 percent of the U.S. sales force.

Dr. Morrissey continued: "As the second approved product to have been discovered at Exelixis, cobimetinib represents a major achievement for our company and for all of the employees, past and present, who contributed to the program since its inception. Our agreement with Genentech and Roche enables Exelixis to participate meaningfully in the product’s commercialization. This includes receiving royalties on ex-U.S. sales and sharing in the profits in the U.S., where our team is fully prepared to co-promote cobimetinib with Genentech pending regulatory approval. Exelixis is excited to be working with Genentech and Roche to ensure that the commercialization phase of our cobimetinib partnership mirrors the productivity and success seen during the compound’s discovery and clinical development."