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FORMER FDA COMMISSIONER HAYES JOINING EM PHARMACEUTICALS

Executive Summary

FORMER FDA COMMISSIONER HAYES JOINING EM PHARMACEUTICALS as president and CEO of the West German firm, E. Merck. In his new position, Arthur Hull Hayes, 53, will head the U.S. subsidiary. Hayes' appointment will become effective July 1, EM announced in a June 6 press release. "The appointment of Dr. Hayes is a strong signal of E. Merck extending its activities in the U.S. pharmaceutical market," the release states. According to the company, EM was established in 1985 for the initial purpose of bringing new E. Merck pharmaceuticals and devices to marketing approval in the U.S. Hayes will be EM's first chief executive. Since leaving FDA in 1983, Hayes has served as provost of the New York Medical College in Valhalla, New York. He is currently president of the U.S. Pharmacopeial Convention. EM has experience with the U.S. regulatory process through joint development projects. Earlier this year, the company licensed a "third generation cardioselective" beta blocker, bisoprolol, to Lederle for marketing in the U.S. and Canada. Under the agreement, Lederle will handle the NDA filing based on U.S. clinical studies sponsored by EM. According to EM, the company does not market any drugs in final formulations in the U.S. at this time. The firm is marketing bulk chemicals in the U.S. In addition, E. Merck and Biocraft signed a joint development and licensing agreement a year ago covering sustained-release products. Hayes will join two other top FDA officials working for German companies on development of drugs for the U.S. market. Former Bureau of Drugs Director Richard Crout is VP-medical and scientific affairs for Boehringer-Mannheim. The former associate director of the new drug evaluation branch at FDA, Marion Finkel, is executive director of R&D at Berlex, the U.S. subsidiary of Schering AG.
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