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BOEHRINGER MANNHEIM TO MARKET MEDCO RESEARCH’s BIDIL

Executive Summary

BOEHRINGER MANNHEIM TO MARKET MEDCO RESEARCH's BIDIL fixed combination isosorbide dinitrate/hydralazine combination for treatment of congestive heart failure under a licensing agreement announced Nov. 9. The non-equity deal will give Boehringer Mannheim Pharmaceuticals Corp. distribution and marketing rights to Bidil in North America. Medco Research will develop and manufacture the product and receive a royalty on sales. Medco plans to begin Phase III trials of Bidil before the end of the year. The company said it expects to file an NDA for the drug in 1995. Medco Research has a use patent for the combo drug. The goal of Medco's clinical trials of Bidil will be to demonstrate that the fixed combination is bioequivalent to hydralazine and isosorbide dinitrate administered separately. Medco believes that data from two Veterans Administration Heart Failure Trials (VHeFT-1 and VHeFT-2) have demonstrated the efficacy of the hydralazine and ISDN combination regimen. The lead investigator for the, VHeFT studies, Jay Cohn, MD, University of Minnesota, is a technical consultant for Medco. As a result of the VHeFT trials, Medco and Boehringer Mannheim said, "vasodilator therapy with hydralazine and ISDN has become standard CHF treatment" for patients who do not respond favorably to the standard regimen of diuretics, digitalis and/or angiotensin-converting enzyme inhibitors. The firms estimate that 20% to 30% of CHF patients (or about 1 mil. people) do not respond to standard therapy. Neither hydralazine nor isosorbide dinitrate is indicated for CHF. Wyeth-Ayerst did seek such an indication for Isordil in 1988. An FDA advisory committee, while suggesting that labeling for both isosorbide and hydralazine should reference the VHeFT-l trials, recommended against an indication for Isordil, citing uncertainty about the effect of each ingredient in the combination. Medco said it plans to seek a mortality reduction claim for Bidil in CHF patients. VHeFT-1 showed that the combination reduced mortality compared to placebo. In VHeFT-2, the ISDN/hydralazine combination had a smaller survival benefit than did Merck's Vasotec (enalapril). However, Medco said, "the combination of hydralazine and ISDN improved exercise capacity and pumping function of the heart to a greater extent than enalapril alone, leading the investigators to conclude that all three drugs may be complementary."
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