Partnering to Expand Therapeutic Boundaries
Exelixis has established additional partnerships and collaborations with other leading pharmaceutical and biopharmaceutical companies. These partnerships are designed to advance the development of a variety of potential therapies for cancer and other serious diseases.
Cobimetinib, an Exelixis-discovered compound, is a reversible inhibitor of MEK, part of the RAS/RAF/MEK/ERK pathway that is frequently dysregulated in human tumors. Cobimetinib is being developed by Genentech, a member of the Roche Group, under a collaboration agreement with Exelixis and is the subject of a broad clinical development program in combination with a variety of investigational and approved therapies.
Cobimetinib is now approved in multiple countries, including the United States, European Union, Switzerland, Canada, Australia and Brazil, to treat specific forms of BRAF mutation-positive unresectable or metastatic melanoma, in combination with vemurafenib. The trade name for cobimetinib is COTELLIC®. For more information on COTELLIC, including important safety information, please click here.
Esaxerenone (CS-3150) is an oral, non-steroidal, selective blocker of the mineralocorticoid receptor (MR), a nuclear hormone receptor implicated in a variety of cardiovascular and metabolic diseases. MR blockers can be used to treat hypertension and congestive heart failure due to their vascular protective effects. Recent studies have also shown beneficial effects of adding MR blockers to the treatment regimen for patients with type 2 diabetes with nephropathy.
Esaxerenone is one of the compounds identified during Exelixis’ research collaboration with Daiichi Sankyo, which the companies entered into in March 2006. Under the terms of the agreement, Exelixis granted Daiichi Sankyo an exclusive, worldwide license to certain intellectual property primarily relating to compounds that modulate MR. In exchange, Exelixis received an upfront payment, research funding for a joint research period, and the potential for clinical development, regulatory and commercialization milestone payments, as well as double-digit royalties on sales. Since the conclusion of the joint research period in November 2007, Daiichi Sankyo has been responsible for all subsequent preclinical and clinical development, and will also oversee regulatory, manufacturing and commercialization activities for the compound.
Following the announcement of positive data from the ESAX-HTN phase 3 pivotal trial, the Japanese Ministry of Health, Labour and Welfare approved esaxerenone as a treatment for patients with hypertension in January 2019. Daiichi Sankyo markets esaxerenone as MINNEBRO® for this indication in Japan. In November 2019, Daiichi Sankyo announced positive results from ESAX-DN, a phase 3 pivotal trial of esaxerenone in patients with diabetic nephropathy. Additional clinical development work is ongoing; for more information on the esaxerenone clinical trial program, please visit www.clinicaltrials.gov.