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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?

To: Richaaard who wrote (966)	3/25/1999 8:06:00 PM
From: harkenman	Read Replies (1) \| Respond to of 1837

Duramed Pharma Up 90% On FDA Mktg Approval For Cenestin NEW YORK (Dow Jones)--Duramed Pharmaceuticals Inc. (DRMD) shares are up more than 85% after the Food and Drug Administration granted the company approval to market Cenestin, a conjugated estrogen product to treat the vasomotor side effects of menopause. Cenestin, which treats symptoms such as hot flashes and night sweats, will be the first major competitor for American Home Products Corp.'s (AHP) blockbuster estrogen-replacement product Premarin, said Eugene Robinson, an analyst for J.J.B. Hilliard W.L. Lyons. Although the analyst estimates that Duramed already has about 10 other products, he said Cenestin marks the company's first push into such a large market since most of Durmamed's other drugs are more "niche-oriented." Premarin, he noted, serves a market that is about $1 billion in size. Robinson, who recently stopped covering Duramed after following the company for about five years, noted that Duramed does have a marketing advantage over American Home Products. That's because Premarin is formulated from the urine of pregnant mares, while Cenestin is a plant-derived synthetic drug. Still, Sidney Taubenfeld, an analyst with Sturza's Medical Research, pointed out that "people are comfortable with Premarin" since it has been on the market for many years. Taubenfeld added that Premarin is also indicated for the prevention and management of osteoporosis, while Cenestin is not. Duramed plans to start a clinical program to evaluate Cenestin in the prevention of the disease. Taubenfeld believes Duramed will therefore have to price Cenestin less than Premarin to drive sales. The company's marketing partner also will be "a key piece of the puzzle," he said. Duramed said it has signed a letter of intent with a Fortune 200 company to help sell and distribute Cenestin. Still, Robinson said the market for both drugs could expand as the baby boom generation ages. In a press release late Wednesday, Duramed said Cenestin will be available by prescription within 90 days. The company hopes the drug will produce more than $100 million in annual sales within 15 to 18 months after it becomes available. Cenestin is Duramed's first non-generic drug. The company initially tried to gain FDA approval to market Cenestin as a generic version of Premarin, but the agency decided that the two products were not equivalent, so Duramed pursued approval for Cenestin as a proprietary, stand-alone drug. Duramed's shares were recently up 6, or 85.7%, at 13 on Nasdaq volume of 16 million, compared with an average daily volume of 239,800. Earlier, the stock set a new 52-week high of 17, surpassing the previous mark of 7 11/32 set Feb. 16. -Joelle Tessler; 201-938-5285