Date: 2015-09-24
Type of information: Nomination
Compound:
Company: Exelixis (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: nomination
Action mechanism:
Disease:
Details: * On September 24, 2015, Exelixis announced three high-level appointments as the company prepares for the potential commercialization of its lead compound, cabozantinib, for the treatment of advanced renal cell carcinoma (RCC) following positive results from the METEOR pivotal phase 3 trial. William Berg, M.D. has joined the company as Senior Vice President of Medical Affairs, Jonathan Berndt as Vice President of Sales, and Gregg Bernier as Vice President of Marketing. As Senior Vice President of Medical Affairs, William Berg, M.D. will oversee medical affairs in the United States. He joins Exelixis after spending more than 12 years at Novartis, where he served in roles of increasing responsibility, including vice president and franchise head within Global Medical Affairs. Notably, Dr. Berg led the Afinitor® Medical Affairs program which was instrumental in the development of Afinitor® in advanced RCC. Prior to Novartis, he was a director of U.S. medical affairs at Aventis Oncology. Before entering the pharmaceutical industry, Dr. Berg served on the faculty of the Memorial Sloan Kettering Cancer Center (MSKCC), where he saw patients as part of the Genitourinary Oncology Service, contributed to the MSKCC risk model for advanced RCC, and researched novel therapies for the disease. Dr. Berg completed his fellowship in medical oncology at MSKCC, training under Robert J. Motzer, M.D. He earned his medical degree from Cornell University Medical College and his Bachelor of Science from Duke University. Vice President of Sales Jonathan Berndt will lead all sales activities for cabozantinib and also direct U.S. co-promotion efforts for cobimetinib, including Exelixis’ plans to field up to 25 percent of the cobimetinib U.S. sales force in the event of a potential regulatory approval later this year. Mr. Berndt joins Exelixis with two decades of commercial sales experience in the biopharmaceutical industry, including multiple oncology product and line extension launches. Most recently, he served as senior director, oncology sales at Gilead Sciences, where he assembled and led the company’s oncology sales team supporting Zydelig®. Prior to Gilead, Mr. Berndt served at Genentech for 13 years. While there, he served in a variety of roles, including directing national and regional sales for products including Rituxan® and Avastin®, and managing sales operations for Herceptin® and Tarceva®. He received his Bachelor of Science in management from Virginia Tech. Exelixis’ new Vice President of Marketing Gregg Bernier will lead the marketing group in its commercialization of cabozantinib for RCC. Mr. Bernier has more than 20 years of experience in biotech and pharmaceutical sales and marketing, primarily in oncology. Prior to joining Exelixis, he served as senior director of marketing at Medivation, where he led the launch of Xtandi® for a new indication in metastatic castration-resistant prostate cancer. Mr. Bernier joined Medivation from Genentech, where he worked on a variety of product launches including Tarceva®, Kadcyla®, Erivedge® and Avastin®, among other products. He has also held positions at Pharmacia and Sanofi. Mr. Bernier received his Bachelor of Arts in advertising at Michigan State University. The new appointments come as Exelixis prepares U.S. and EU regulatory filings for cabozantinib in advanced RCC, and awaits a U.S. regulatory decision on its partner Genentech’s application for cobimetinib. In July, Exelixis announced top-line results from METEOR, its phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic RCC who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. Cobimetinib, the Exelixis-discovered selective inhibitor of MEK, was recently approved in Switzerland for use in combination with vemurafenib as a treatment for patients with advanced melanoma, and has a Prescription Drug User Free Act action date of November 11, 2015 in the United States. If cobimetinib 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. Having exercised its option to co-promote the compound in the United States, Exelixis is prepared to field up to 25 percent of the U.S. sales force.
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