Thursday, January 06, 2000

Drug maker makes key hire


Duramed focus on estrogen product

Bloomberg News and The Cincinnati Enquirer

        Duramed Pharmaceuticals Inc. struggled unsuccessfully for years to get approval for a generic version of Wyeth-Ayerst's Premarin. Wednesday, the company said it hired a former Wyeth-Ayerst executive to help expand use of its brand-name entry in the estrogen market.

        Dr. Raymond Klein, previously senior director for global medical affairs at the Wyeth-Ayerst Laboratories unit of American Home Products Corp., will oversee Duramed's research efforts into new uses for its estrogen product Cenestin.

        Pleasant Ridge-based Duramed's shares rose 311/4 cents to $7.50 Wednesday.

        Duramed suffered a setback in May 1997 when the U.S. Food and Drug Administration said it couldn't approve generic versions of Premarin, including one formulated by Duramed, until more was known about how it works. The company's version of the most widely prescribed drug in the United States had been produced with FDA guidance and contained most of the ingredients found in Premarin.

        Duramed would have been able to claim all the benefits of Premarin for its drug, including its use in treating and preventing osteoporosis, had it been accepted as an equivalent. Instead, the company conducted short-term clinical trials to prove that it could ease hot flashes, night sweats and other menopause symptoms — and won approval as a brand-name prescription drug in March.

        Now the company is undertaking the lengthy, expensive studies needed to prove Cenestin is effective for osteoporosis and perhaps for heart disease.

        In October, Duramed and Solvay Pharmaceuticals of Marietta, Ga. teamed up to promote three hormone products, including Cenestin. The joint marketing agreement was to produce a combined national sales force of about 300, more than double Duramed's sales staff at the time.

        At Wyeth-Ayerst, Dr. Klein was responsible for studies on the effect of estrogen replacement therapy on heart disease, Alzheimer's disease, eye disorders and other conditions. He will have a similar role at Duramed.

       



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