Exelixis' Cometriq Approved in the EU - Analyst Blog

Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.

Earlier this week, Exelixis, Inc. EXEL announced that Cometriq (cabozantinib) received conditional marketing authorization from the European Commission EC for the treatment of adults suffering from progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC).

Cometriq, which is already approved in the U.S. for the treatment of progressive, metastatic MTC, generated net sales of $4.3 million in the fourth quarter of 2013. Cometriq has orphan drug status for the treatment of MTC in the EU. Exelixis has partnership with Swedish Orphan Biovitrum (Sobi) for the commercialization of Cometriq in the EU.

However, Cometriq label has boxed warnings related to the risk of gastrointestinal perforations and fistulas and severe hemorrhage.

We note that Exelixis is conducting an overall survival analysis of the phase III (E fficacy of X L184 (Cabozantinib) in A dvanced M edullary Thyroid Cancer or EXAM) study on Cometriq in patients with progressive, metastatic MTC. Results from this study should be out during the course of the year.

Meanwhile, Exelixis is working towards strengthening its pipeline. The company is conducting two phase III studies on Cometriq − COMET-1 and COMET-2 − in patients with metastatic castration-resistant prostate cancer (CRPC), whose disease progressed after treatment with Sanofi's SNY Taxotere and some other therapies.

As far as the COMET-1 study is concerned, Exelixis said earlier this week that an interim analysis of the study has been completed at the end of 387 events. The Independent Data Monitoring Committee (IDMC) recommended the study to advance to its final analysis with 578 events. Top-line data from both COMET-1 and COMET-2 studies are expected later in the year.

Exelixis carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Alexion Pharmaceuticals, Inc. ALXN and Alkermes plc ALKS. Both stocks carry a Zacks Rank #1 (Strong Buy).