September 24, 2015
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – In anticipation for possible regulatory approval of two new drugs, cabozantini and cobimetinib, Bay Area-based Exelixis has hired three new executives to guide the company through commercialization and an expansion of its medical affairs, the company announced this morning.
William Berg 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. The company said the three new executives’ experience in oncology will help spearhead Exelixis’ future.
“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,” Michael Morrissey, president and chief executive officer of Exelixis, said in a statement. “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 preparing regulatory filings in both the United States and European Union for its two cancer drugs. In July, Exelixis announced top-line results from METEOR, its phase III pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma, a type of kidney cancer, who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In August, the U.S. Food and Drug Administration granted Cabozantinib breakthrough therapy designation for RCC.
Cabozantinib is currently marketed in capsule form under the brand name Cometriq in the United States for the treatment of progressive, metastatic medullary thyroid cancer. It is also approved in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC.
Cobimetinib, the Exelixis-discovered selective inhibitor of MEK, was approved in Switzerland in August for use in combination with vemurafenib as a treatment for patients with advanced melanoma. The FDA is expected to rule on the drug on Nov. 11. 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, the company said. Exelixis shares rights with Genentech for cobimetinib. The two companies inked a deal to co-develop the drug in 2006.
Exelixis is hoping the approval of the two drugs will turn around the company’s fortunes after it was forced to lay off 70 percent of its workforce after a 2014 trial for cabozantinib failed to meet its goal of extending the lives of prostate cancer patients. The trial’s failure and the layoffs caused the stock to drastically fall. is currently trading at 6.16 per share.
