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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Trey Yon who wrote (592)	8/4/2000 4:26:07 PM
From: Russian Bear	Read Replies (1) \| Respond to of 666

quote.bloomberg.com Coulter Says It's in Final Stages of Preparing Drug Application By Jim Finkle South San Francisco, California, Aug. 3 (Bloomberg) -- Coulter Pharmaceutical Inc., a biotechnology company, said it's in ``final stages'' of its efforts to file again for approval of the experimental cancer drug Bexxar. In August 1999, the Food and Drug Administration rejected Coulter's application for approval of Bexxar, a radioactive injected drug for patients suffering from non-Hodgkin's lymphoma. The agency said the original application didn't have enough data analysis and that some sections should be reformatted. At the time, Coulter said it would refile within a few months, a timeline that was extended indefinitely in October when the company said the FDA wasn't providing it with information about what it needed as quickly as expected. ``Since we were only half in control, we were unable to give a more definitive timeline,'' Coulter Chief Executive Michael Bigham said in an interview. ``We believe we've gotten all the feedback that is necessary. We believe we can address the issues and we believe we can finish it from here,'' he said. Still, he declined to say when he expects to refile for approval. South San Francisco, California-based Coulter is in a race with Idec Pharmaceuticals Corp., which has said it plans to file for approval of a rival drug in the fourth quarter of this year. Both drugs contain radioactive substances linked to antibodies, which are designed to attach themselves to cancer cells, then dose tumors with radiation. Shares in Coulter have tumbled 10 percent over the past year. The Nasdaq Biotech Index of 198 biotechnology stocks has more than doubled during the same period and shares in San Diego-based Idec have soared 172 percent. Before the FDA rejected Coulter's first application, some analysts predicted that Coulter would win U.S. approval of its drug at least 18 months ahead of Idec. Now it's hard to say which drug will be the first to market, said Idec Chief Operating Officer William Rohn. ``Today we're pretty close,'' Rohn said. ``It may well be that their first-mover advantage has disappeared.'' Whichever drug makes it to market first will have a head start in winning over doctors looking for treatments to use on patients who have failed chemotherapy along with Rituxan, a bioengineered drug marketed by Idec and Genentech Inc. The market for such patients is worth between $250 million and $275 million a year, said Rob Toth, a Prudential Vector Healthcare Group analyst with an ``accumulate'' recommendation on Coulter and Idec. ``The agent that gets approved first and gets into the market first is going to have a key advantage,'' Toth said.