What: Shares of Exelixis (NASDAQ:EXEL), a small-cap biotechnology company focused on developing novel therapies to treat cancer, surged higher by 30% in January per S&P Capital IQ after announcing that it had restructured its distribution agreement for Cometriq. Shares added a further surge following Roche's (OTC:RHHBY) earnings report, which we'll get to in a moment.
So what: First, Exelixis received a nice boost after announcing that it had restructured its distribution agreement with Swedish Oprhan Biovitrum in the EU, Switzerland, Norway, Russia, and Turkey for Cometriq, the company's approved metastatic medullary thyroid cancer drug. The current agreement was set to expire at the end of 2015 but has since been renewed to extend through 2019. Under the terms of the new deal Exelixis will transition from a fixed-fee payment structure to one based on total sales of Cometriq, which should help slow Exelixis' current cash burn rate.
The other factor that played a key role in pushing Exelixis' shares higher later in the month were Roche's year-end results. If you recall, Roche is a partner of Exelixis in the development of metastatic melanoma drug combination involving Roche's FDA-approved Zelboraf and Exelixis' developed compound cobimetinib (Roche submitted new drug applications for this combo back in December).
During Roche's conference call the company unveiled previously unannounced phase 1 studies, one of which includes an anti-PDL1 drug (one that utilizes the body's immune system to help fight cancer) in combination with cobimetinib for solid tumors. The prospect of cobimetinib being used in combination with a cancer immunotherapy is very exciting. A readout of the initial results is expected sometime later this year.
Now what: As a shareholder of Exelixis I can attest that it had an awful 2014 and was one of biotech's worst performing stocks. Yet, even with the loss of Cometriq's potential indication for metastatic castration-resistance prostate cancer (mCRPC) things are looking up.
For example, in the second-quarter we should hear from Exelixis with its phase 3 readout from the METEOR trial, which is studying Cometriq as a treatment for metastatic renal cell carcinoma. What's noteworthy about this trial is that the primary endpoint is just a statistically significant improvement in progression-free survival over Afinitor. Overall survival improvements, which is what did Cometriq in during the COMET-1 mCRPC trial, will be a secondary endpoint. Even in the COMET-1 study Cometriq delivered statistically significant PFS improvement, so I'm confident it has a good shot at hitting its primary endpoint in the METEOR study.
We also have the coBRIM study which, as I mentioned above, allowed the combo of Zelboraf and cobimetinib to deliver significant improvements over the current standard of care for BRAF V600-mutation positive advanced melanoma patients. The market for melanoma drugs is a bit crowded, but this combo should be able to hold its own with Roche at the helm of commercialization.
All told I expect this to be an exciting year for Exelixis and I have no reason to sell my shares with so many catalysts on the horizon.