Exelixis, Inc. (NASDAQ:EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved COTELLIC™ (cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib. COTELLIC and vemurafenib are not used to treat melanoma with a normal BRAF gene. COTELLIC is a selective inhibitor of MEK that was discovered byExelixis and is the subject of a worldwide collaboration agreement between Exelixisand Genentech, a member of the Roche Group. This is the second regulatory approval for COTELLIC, which was first approved in Switzerland in late August 2015.
Genentech sponsored the COTELLIC U.S. New Drug Application (NDA), having led the compound’s development since midway through the initial phase 1 clinical trial. Genentech filed its NDA in December 2014; the FDA accepted the filing and granted it Priority Review in February 2015. Separately, Roche filed a Marketing Authorization Application (MAA) with the European Medicines Agency in late 2014, and theCommittee for Medicinal Products for Human Use issued a positive opinion for the MAA in September 2015. Roche anticipates a decision from the European Commission by year-end.
“The approval of COTELLIC for use in combination with vemurafenib is an important milestone for the melanoma community, and also for Exelixis, as it is the second medicine discovered in our laboratories to receive regulatory approval in the United States,” said Michael M. Morrissey, Ph.D., president and chief executive officer ofExelixis. “We look forward to working with Genentech and Roche to bring this important new treatment option for BRAF V600E and V600K mutation-positive advanced melanoma to patients, physicians, and caregivers.”
The COTELLIC approval is based on data from the phase 3 coBRIM study, which showed COTELLIC plus vemurafenib reduced the risk of disease worsening or death (progression-free survival; PFS) by about half in people who received the combination (HR=0.56, 95 percent CI 0.45-0.70; p<0.001), with a median PFS of 12.3 months for COTELLIC plus vemurafenib compared to 7.2 months with vemurafenib alone. An interim analysis also showed the combination of COTELLIC and vemurafenib helped people live significantly longer (overall survival) than vemurafenib alone (HR=0.63, 95 percent CI 0.47-0.85; p=0.0019). The objective response rate (tumor shrinkage) was higher with COTELLIC plus vemurafenib compared to vemurafenib alone (70 vs. 50 percent; p<0.001), as was the complete response rate (complete tumor shrinkage, 16 vs. 10 percent).
Possible serious side effects with COTELLIC include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of COTELLIC include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. COTELLIC can also cause changes in blood test results.
The final overall survival analysis from the coBRIM trial will be presented at the Society for Melanoma Research 2015 International Congress, which will be held in San Francisco from November 18-21.
In November 2013, Exelixis exercised its option under the 2006 collaboration agreement to co-promote COTELLIC in the United States; accordingly, Exelixis will field 25% of the sales force, closely coordinating its efforts with Genentech. 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. The company is also eligible to receive royalties on any sales of the product outside the country, including in Switzerland, where COTELLIC was first approved, and in the European Union, where Roche anticipates a regulatory decision by year-end.
Dr. Morrissey continued: “The approval of COTELLIC represents a major achievement for Exelixis and for all of the employees, past and present, who contributed to the program since its inception. As we enter the commercialization phase of our partnership with Genentech and Roche, our agreement enables Exelixis to participate meaningfully in the product’s introduction and ongoing sales. In the United States, our team is fully prepared to co-promote COTELLIC. Outside of the country, we are eligible to receive royalties on sales. Exelixis is excited to be working with Genentech and Roche to ensure that the commercialization phase of our cobimetinib partnership mirrors the productivity and success seen during COTELLIC discovery and clinical development.” (Original Source)
Shares of Exelixis opened today at $6.06 and are currently trading up at $6.08. EXEL has a 1-year high of $6.81 and a 1-year low of $1.26. The stock’s 50-day moving average is $5.89 and its 200-day moving average is $4.82.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on September 28, Cowen analyst Eric Schmidt reiterated a Buy rating on EXEL. Separately, on September 18, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and John Sonnier have a total average return of 31.8% and 20.8% respectively. Schmidt has a success rate of 60.3% and is ranked #34 out of 3832 analysts, while Sonnier has a success rate of 66.0% and is ranked #202.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.