Vertex Pharmaceuticals (CA) Rises After FDA Staff Says Hepatitis C Drug Is Effective

Boston Business Journal -- Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) saw its shares surge 12 percent on Tuesday, on a strong hint that the company’s hepatitis C drug candidate telaprevir will be approved by the U.S. Food and Drug Administration. An FDA advisory panel will meet Thursday to evaluate the potential therapy, and if the panel gives a positive opinion, it is very likely to be approved on May 23. The FDA released briefing documents Tuesday, ahead of the meeting, supporting Vertex’s claims about the drug’s effectiveness.

The FDA briefing’s read in part, “Overall, the FDA review team’s independent analyses confirmed the Applicant’s primary efficacy findings and many secondary endpoint analyses for all pivotal clinical trials.”

Vertex spokesman Zachry Barber said Tuesday, “We look forward to Thursday’s advisory committee meeting where we will discuss the telaprevir information posted today by the FDA,” but declined to comment further.

If the drug is approved, it is expected to quickly reach blockbuster status, bringing in more than $1 billion per year. The drug’s approval is expected to turn Vertex into a profitable biotechnology company, joining its local peers: Weston, Mass.-based Biogen Idec (Nasdaq: BIIB), Waltham, Mass.-based Alkermes, Inc. (Nasdaq: ALKS), Lexington, Mass.-based Cubist Pharmaceuticals (Nasdaq:CBST), and Cambridge, Mass.-based Genzyme Corp, which is now a subsidiary of French drug maker Sanofi-Aventis (NYSE: SNY).

Vertex’s stock was trading at $53.74 in midday trading, up from $48.04 at the previous close.