San Francisco Bay Area biotech firm Exelixis (NASDAQ: EXEL) is bringing on board three new executives in anticipation of two drugs gaining FDA approval. The company, trying to turn around a bad run the past few years, as Xconomy wrote about in June, hired William Berg as senior VP of medical affairs, Jonathan Berndt as VP of sales, and Gregg Bernier as VP of marketing.
Exelixis is waiting to hear from the FDA whether cobimetinib can come to market as part of a combination treatment for patients whose advanced melanoma is driven by a genetic mutation known as BRAF V600. A decision is due by November 11. The date was originally supposed to be August 11, but the drug agency pushed it back this summer.
Exelixis also has in hand positive Phase 3 study data for another drug, cabozantinib, in renal cell carcinoma, a type of kidney cancer. The announcement of top-line data in July bumped Exelixis shares from the $3 range above $6 a share. It will present the full data set this weekend at the European Cancer Congress.
Exelixis owns full rights to cabozantinib, and it plans to submit applications to the FDA and European regulators for approval in coming months. The company had to retrench last year when cabozantinib failed a big test in prostate cancer.
The company shares rights with cobimetinib with Roche’s Genentech unit, and it plans to take part in the sales and marketing efforts in the U.S.