Exelixis, Inc. (Nasdaq: EXEL) today reported financial results for the fourth quarter and year ended December 31, 2012.
Q4 2012 Highlights and Recent Events
- The FDA approved COMETRIQ™ (cabozantinib) for the treatment of progressive, metastatic medullary thyroid cancer (MTC) on November 29, 2012. Approval was based on the results of EXAM, a randomized phase 3 clinical trial conducted under a Special Protocol Assessment in 330 patients with progressive, metastatic MTC, which met its primary efficacy endpoint progression-free survival (PFS). The median PFS on the cabozantinib arm was 11.2 months versus 4.0 months on the placebo arm, an improvement by 7.2 months. The hazard ratio was 0.28, (95% CI 0.19, 0.40), p < 0.0001.
- Announced in November 2012 that the European Medicines Agency (EMA) completed validation and accepted for review Exelixis' marketing authorization application (MAA) for COMETRIQ for the proposed indication of treatment of progressive, unresectable, locally advanced or metastatic MTC. Completion of the MAA validation process confirms the submission is sufficient to permit a substantive review for marketing authorization in the European Union.
- Announced in early January 2013 that Exelixis plans to initiate phase 3 pivotal trials of cabozantinib in advanced hepatocellular cancer (HCC) and metastatic renal cell cancer (RCC).
- Announced the commercial availability of COMETRIQ for the treatment of patients with progressive, metastatic MTC on January 24, 2013.
“Exelixis achieved an important milestone in the fourth quarter of 2012 with the approval of our first product, COMETRIQ, for the treatment of progressive, metastatic MTC,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “We are proud of this important clinical and regulatory achievement and pleased to have launched COMETRIQ in the progressive, metastatic MTC indication. Our focus moving forward remains on expanding the commercial franchise for cabozantinib. Our primary objective in 2013 is to execute on the broad cabozantinib clinical development program, including our COMET pivotal trial program in metastatic, castration-resistant prostate cancer (CRPC), planned pivotal trials in HCC and RCC, and additional randomized phase 2 trials to generate data that continue to differentiate the compound and allow us to maximize its clinical and commercial potential.”