Exelixis, Inc. was founded and incorporated in 1994, and we are currently based in South San Francisco, California. Exelixis, from the Greek word for “evolution,” is a biopharmaceutical company committed to the discovery, development and commercialization of new medicines to improve care and outcomes for people with cancer.
Over the past fifteen years, we have established a broad development platform, laying the foundation for our continued efforts to bring new therapies for cancer to patients in need. The history of our lead compounds, cabozantinib and cobimetinib, tells the story of our evolution as a company. Each of these compounds was discovered in our own laboratories and advanced by us into clinical development.
In addition, we have leveraged our earlier stage drug discovery and development capabilities to establish multiple partnerships and collaborations with leading pharmaceutical and biopharmaceutical partners. These alliances are designed to advance the development of Exelixis-discovered therapies, and allow the organization to focus on maximizing the potential of our lead compound cabozantinib, an inhibitor of multiple tyrosine kinases.
Cabozantinib received its first regulatory approval in 2012 for patients with progressive, metastatic medullary thyroid cancer, for which it is marketed under the trade name COMETRIQ® capsules; click here for important safety information about COMETRIQ. Since then, alongside our collaborators, we have advanced a broad, global clinical development program that is evaluating cabozantinib in approximately 45 planned or ongoing clinical trials. In April 2016, cabozantinib received its second U.S. approval, as a treatment for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Cabozantinib is marketed as CABOMETYX™ tablets for this indication. Click here for important safety information about CABOMETYX. While our commercialization efforts for CABOMETYX and COMETRIQ are focused in the U.S., we have licensed development and commercialization rights to cabozantinib outside of the U.S. to Ipsen and Takeda. Ipsen has rights to cabozantinib outside of the U.S. and Japan, and Takeda has rights to cabozantinib in Japan. CABOMETYX has also been approved in the European Union for the treatment of advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy where it is currently being launched by Ipsen. In addition to its approved indications, cabozantinib is being investigated as a single agent or in combination with other agents including immune checkpoint inhibitors in a variety of other cancers.
A second Exelixis-discovered compound, cobimetinib, also has broad potential as a cancer treatment. It is subject to a worldwide collaboration between Exelixis and Genentech (a member of the Roche Group). Cobimetinib has received regulatory approval for its first indication, BRAF V600 mutation-positive advanced melanoma, in multiple territories, including the United States, European Union, Switzerland, Canada, Australia and Brazil, and it is marketed under the trade name COTELLIC®. Genentech is also further exploring cobimetinib’s potential through a clinical development program where it is being evaluated in combination with investigational and approved therapies, including immunotherapy agents. Cobimetinib is expected to be the subject of three phase 3 pivotal combination trials in 2017.
Supported by growing revenues from the cabozantinib franchise and careful management of our expenses, we are in the position to now fund our continued growth from our ongoing operations, a significant milestone for Exelixis. This enables us to reinvest in our business, pursue in-licensing opportunities and resume in-house discovery operations – important elements of our plan to expand our pipeline and deliver a new generation of Exelixis medicines.