RBC Capital Markets expects Vertex Pharmaceuticals Inc.'s (NASDAQ: VRTX) Incivek (telaprevir) to treat hepatitis C is likely to be approved on or around May 23.
"Once approved, we believe near-term performance in Vertex shares will be tied to launch metrics and continued progress in its pipeline including its Cystic Fibrosis (CF) drugs. We continue to believe that Incivek will receive a clean, broad label, including a simple treatment algorithm and side-effect management program," said Jason Kantor, an analyst at RBC Capital Markets.
Kantor said the most important non-hepatitis C virus (HCV) news flow will be in CF with a VX-770 new drug application (NDA) submission expected in second half of 2011. Upside could come from a regulatory delay for boceprevir; however, the consensus view is that both Incivek and boceprevir will be approved at approximately the same time.
While both Incivek and boceprevir received unanimous recommendations for approval, the AdCom viewed the Incivek Phase III program as substantially more comprehensive and convincing. Kantor believes this is likely to result in a more straightforward and broad label with simpler treatment algorithms (e.g., including null responders) and side-effect management programs (e.g., for rash and anemia).
