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).
Kantor said the panel also backed response-guided therapy for prior relapsers, which could permit a large portion of treatment experienced patients to benefit from a shorter duration of treatment than was tested in the Phase III program.
Kantor forecasts price per patient of about $36,000 in the U.S., which he believes is in line with Street estimates. In his view, the Street would probably like Incivek and boceprevir to be priced higher. Vertex also disclosed that launch infrastructure is in place (115 sales specialists) and he expects the product to be on the market within 3-6 weeks of approval.
Vertex Pharmaceuticals stated that the rate-limiting step is how quickly it can get the drug supply out through the channels. Overall, Kantor continues to give the marketing advantage to Incivek.
Vertex's key events through year-end 2011 include: FDA approval, labeling, and pricing for Incivek and boceprevir; upcoming combination data of VX-770 and VX-809 in CF; NDA and Marketing Authorization Application (MAA) acceptances for VX-770; VX-509 (Inflammatory Diseases) Phase II data in rheumatoid arthritis (RA); and combination Incivek and VX-222 data, said Kantor.
Vertex stock fell 1.99 percent to $53.65 in the pre-market trading on the NASDAQ Stock Market.