SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (NASDAQ:EXEL) today 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.
"Will, Jon, and Gregg bring a wealth of oncology experience and successful track records gained at some of the biopharmaceutical industry's most prestigious companies. Their new roles on the Exelixis team will help to ensure we are well-positioned to execute on our many critical milestones in the months to come."
"Exelixis is moving rapidly to thoughtfully expand our medical affairs and commercial capabilities in advance of our planned U.S. and EU regulatory filings for cabozantinib in advanced renal cell carcinoma in late 2015 and early 2016, respectively," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Will, Jon, and Gregg bring a wealth of oncology experience and successful track records gained at some of the biopharmaceutical industry's most prestigious companies. Their new roles on the Exelixis team will help to ensure we are well-positioned to execute on our many critical milestones in the months to come."
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.
Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its development and commercialization efforts primarily on cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine kinases. Another Exelixis-discovered compound, cobimetinib, a selective inhibitor of MEK, received its first regulatory approval in Switzerland and is being evaluated by Roche and Genentech (a member of the Roche Group) in a broad development program under a collaboration with Exelixis. For more information, please visit the company's web site at www.exelixis.com.
This press release contains forward-looking statements that are subject to risk and uncertainty, including, without limitation, the therapeutic and commercial potential of cabozantinib and cobimetinib as new treatment options for second-line RCC and advanced melanoma patients, respectively; the potential for regulatory filings, advancement and eventual approvals for cabozantinib and cobimetinib, as stated, in the U.S. and EU; whether Exelixis will be well-positioned to execute on critical milestones in the months to come; the plan of Genentech and Exelixis to share U.S. profits and losses and U.S. marketing and commercialization costs for cobimetinib; Exelixis' potential receipt of royalties on sales of cobimetinib products outside the U.S.; and, Exelixis' preparedness to support U.S. co-promotion efforts for cobimetinib in the U.S. Words such as "expand," "in advance", "planned", "will", "ensure", "execute", "months to come", "prepare", "await", "if", and "entitled" or other similar expressions identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis' current plans, assumptions, beliefs, expectations, and projections. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements, which include, without limitation: risks related to the clinical, therapeutic and commercial potential of cabozantinib and cobimetinib; risks related to Exelixis' ability to build corporate and commercial infrastructure, including integrating new capabilities, such that it is able to execute its plans effectively; risks and uncertainties related to regulatory review and approval processes and Exelixis' compliance with applicable legal and regulatory requirements; risks related to market competition, changes in economic and business conditions, and other factors discussed under the caption "Risk Factors" in Exelixis' quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 11, 2015, and in Exelixis' other filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S. trademarks.
Susan Hubbard, 650-837-8194
Investor Relations and Corporate Communications
For Exelixis, Inc.
Hal Mackins, 415-994-0040