Exelixis, Inc. (NASDAQ:EXEL) announced that the European Commission (EC) has approved COTELLIC™ (cobimetinib) for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. COTELLIC was discovered by Exelixis and is now the subject of a collaboration between Exelixis and Genentech, a member of the Roche Group. Rochesponsored COTELLIC’s EU Marketing Authorization Application, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2015.

“The approval of COTELLIC by the European Commission for use in combination with vemurafenib is an important milestone in the development of new treatments that can help patients with advanced melanoma,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We look forward to continuing to execute on our collaboration agreement for COTELLIC.”

The approval in the EU is based primarily on results of the phase 3 coBRIM study, which showed that people with previously untreated BRAF V600 mutation-positive advanced melanoma who were being treated with the MEK inhibitor COTELLIC in combination with vemurafenib lived a median of one year (12.3 months) without their disease worsening or death (progression-free survival; PFS) compared to 7.2 months with vemurafenib alone (hazard ratio [HR]=0.58, 95 percent confidence interval [CI] 0.46-0.72).1

The objective response rate with the combination was 70 percent (16 percent complete response [CR], 54 percent partial response [PR]) compared to 50 percent (11 percent CR, 40 percent PR) in the vemurafenib arm.1 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.

Additional data were presented in November 2015 at the Society for Melanoma Research congress demonstrating that the combination of COTELLIC plus vemurafenib met its secondary endpoint of improving OS compared to vemurafenib alone. Rocheand Genentech have guided that these data will be submitted to the European Medicines Agency for consideration and inclusion in the label.

After discovering COTELLIC internally, Exelixis advanced the product to investigational new drug (IND) status. In late 2006, the company entered into its worldwide collaboration with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop COTELLIC. Under the collaboration agreement,Exelixis is eligible to receive low double-digit royalties on sales of COTELLIC outsidethe United States. 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. In November 2013, Exelixis exercised its option to co-promote COTELLIC in the United States and will field 25 percent of the U.S. sales force.

COTELLIC in combination with vemurafenib is now approved in the EU and Switzerlandfor the treatment of people with BRAF V600 mutation-positive advanced melanoma. The combination is approved in the United States for the treatment of patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. Further country approvals are anticipated in 2016. (Original Source)

Shares of Exelixis are currently trading at $5.53, up $0.03 or -0.60%. 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 $5.80 and its 200-day moving average is $5.03.

On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on November 23, Leerink Swann analyst Michael Schmidt maintained a Hold rating on EXEL, with a price target of $6, which implies an upside of 9.1% from current levels. Separately, on September 28, Cowen’s Eric Schmidt 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, Michael Schmidt and Eric Schmidt have a total average return of 13.1% and 31.3% respectively. Schmidt has a success rate of 54.1% and is ranked #518 out of 3641 analysts, while Schmidt has a success rate of 57.5% and is ranked #39.

Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.