Gardasil Trial Termination Is More Good News For Merck
This article was originally published in The Pink Sheet Daily
Executive Summary
Data and safety monitoring board’s recommendation to switch placebo patients in FUTURE studies to the vaccine comes on the heels of an “approvable” letter for Novartis’ potential Januvia competitor Galvus.
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A data and safety monitoring board has recommended the termination of two large clinical studies involving Merck's human papilloma virus vaccine Gardasil due to positive efficacy results. "In light of the high efficacy of Gardasil observed in the large clinical trials, FUTUREI and II, the independent [DSMB]of these studies recommended that women in the placebo group should be vaccinated with Gardasil," Merck and Sanofi-Aventis' European joint venture Sanofi Pasteur MSD announced Feb. 27. The firm markets Gardasil in the EU, where it has been approved since September. The DSMB's recommendation follows FDA's recent "approvable" decision for Novartis' DPP-4 inhibitor Galvus (vildagliptin) (1 (Also see "Galvus “Approvable” Letter Requests Additional Study In Renal Failure Patients" - Pink Sheet, 26 Feb, 2007.)). Had it been approved, Galvus would have been the second DPP-4 inhibitor on the U.S. market and would have generated direct competition for Merck's type 2 diabetes treatment Januvia (sitagliptin). Some analysts have predicted a delay of at least one year for Galvus due to the decision. As a result of the Gardasil trials' early termination, Merck estimates a total of 4,300 women will be vaccinated in European study centers, with a goal to complete vaccination by the end of 2007. "In a similar way, vaccination of almost 4,500 women in many other countries around the world, including the United States, Australia and Canada, has begun or is anticipated to begin soon," Sanofi Pasteur MSD said. "In Europe, vaccination of women in the placebo groups of the FUTURE I and II studies has already begun in study centers in Germany, Sweden, Denmark and Austria. In other countries, vaccination will start within the next days or weeks. In the United Kingdom, vaccination starts today." The joint venture noted that "accelerated discussions are under way in most European countries to integrate human papilloma virus vaccination in each country's recommendation and reimbursement program." Gardasil is approved in 15 European countries. Merck recently halted its U.S. lobbying efforts for individual state legislation requiring vaccination with Gardasil for school entry. The decision followed discussions with such third-party stakeholders as the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and the American Academy of Pediatrics. - Lee Szilagyi ([email protected]) |