Shares of Exelixis Inc. (EXEL) are up an impressive 78% year-date compared to 19% gain by the iShares NASDAQ Biotechnology Index during the same period.
Exelixis is a commercial-stage biopharmaceutical company, having three marketed drugs, and a well-stocked pipeline.
The Company’s first marketed product is COMETRIQ, approved by the FDA in November 2012 for the treatment of patients with progressive, metastatic medullary thyroid carcinoma. Cotellic, indicated for advanced melanoma, is Exelixis’ second drug to pass regulatory muster, and it secured FDA approval in November 2015. Cotellic is promoted in association with Roche’s Genentech. The lead drug of the Company is CABOMETYX, approved by the FDA in April 2016 as second or later lines of therapy for patients with advanced renal cell carcinoma.
COMETRIQ and CABOMETYX are derived from Cabozantinib, an inhibitor of multiple tyrosine kinases, which function as an “on” or “off” switch in many cellular functions. COTELLIC is a formulation of Cobimetinib, a selective inhibitor of protein MEK.
In 2016, the Cabozantinib franchise generated net product revenue of $135.4 million, an increase of 296 percent year-over-year. Cotellic brought in collaboration revenue of $2.8 million for Exelixis last year as a result of royalties on ex-U.S. sales of the drug.
The Company is exploring Cabozantinib in number of other indications, some of which are:
— Cabozantinib as first-line monotherapy for advanced renal cell carcinoma, which successfully met the endpoints in a phase II trial dubbed CABOSUN. The Company remains on target to complete a supplemental New Drug Application for Cabozantinib as a treatment of first-line advanced renal cell carcinoma in the third quarter of 2017.
— Cabozantinib in combination with Bristol Myers’ Opdivo/Yervoy in first-line renal cell carcinoma. A phase III trial of this combination, co-funded by Bristol Myers, is expected to start later this year.
— Cabozantinib as a second line therapy in hepatocellular carcinoma. A phase III pivotal trial of Cabozantinib is ongoing in patients with advanced hepatocellular carcinoma, dubbed CELESTIAL. The second interim analysis of the trial is expected in the second half of 2017.
Similarly, Cobimetinib is also being explored in additional indications, a few of which are the following:
As mentioned earlier, Cobimetinib is being developed in partnership with Genentech, a member of the Roche Group.
— A combination of Cobimetinib and Atezolizumab in third-line…