J&J/Vertex HCV Protease Inhibitor Results Tempered By Higher Adverse Events
This article was originally published in The Pink Sheet Daily
Executive Summary
Vertex says Phase III trials still on track for 2007.
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Vertex Pharmaceuticals announced promising efficacy results from an ongoing Phase IIb trial for its hepatitis C treatment telaprevir (VX-950) Dec. 13, but the data were tempered somewhat by a higher incidence of adverse events in the treatment arms. In a planned interim safety analysis, Vertex reported that 9 percent of patients in the telaprevir dosing arms discontinued treatment due to adverse events, and that the serious adverse event rate was 3 percent. In comparison, the figures were 3 percent and 1 percent, respectively, in the control arm. The Cambridge, Mass.-based firm said discontinuations were primarily due to rash, gastrointestinal disorders and anemia. The common adverse events were similar between the two groups, Vertex said, and characteristic of known side effects for interferon and ribavirin. In the double-blind, placebo-controlled PROVE 1 trial, 175 treatment-naive patients were placed in one of three arms treated with peg-interferon alfa-2a, ribavirin and telaprevir. In a fourth arm, 75 patients received peg-IFN, ribavirin and placebo. After 12 weeks, 88 percent of patients in the treatment arm (65 of 74) for whom data were available had undetectable HCV RNA, compared to 52 percent (17 of 33) in the placebo arm. As a result, Vertex received a $15 million milestone payment from development partner Johnson & Johnson. Vertex told "The Pink Sheet" DAILY that the firm is on track to begin Phase III trials in 2007, with an NDA likely to follow in 2008. In the next few weeks, Vertex said it will begin PROVE 3, which is slated to enroll 400 treatment-experienced patients. Complete enrollment of PROVE 2, which is being conducted in Europe, is expected in the next few weeks with 320 patients. Although Vertex has commercial rights to telaprevir in North America, J&J has rights in Europe, South America, Australia and the Middle East (1 (Also see "J&J, Vertex Partner To Commercialize VX-950 For Hepatitis C" - Pink Sheet, 30 Jun, 2006.)). In Japan, Vertex has partnered with Mitsubishi Pharma. The HCV space has heated up this year, most recently in a preclinical deal between Abbott and Enanta Pharmaceuticals for protease inhibitors, worth up to $300 mil. (2 (Also see "Abbott Wins Rights To Enanta’s Preclinical HCV Protease Inhibitors" - Pink Sheet, 12 Dec, 2006.)). - Jonathan M. Block ([email protected]) [Editor's note: An interview with Vertex CEO Joshua Boger is featured in an upcoming F-D-C Reports' guide on deal strategies. For more information, visit 3 http://www.fdcreports.com/guides.] |