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Biotech / Medical : Millennium Pharmaceuticals, Inc. (MLNM) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1508)	5/13/2003 8:24:24 PM
From: Ian@SI	Read Replies (1) \| Respond to of 3044

DJ Newswires coverage of the story... Velcade Approved In Four Months >MLNM WASHINGTON (Dow Jones)--Millennium Pharmaceuticals Inc. (MLNM) received government approval late Tuesday for Velcade, a new type of treatment for the rare blood cancer multiple myeloma. The Food and Drug Administration had until July 21 to make a decision on Velcade, but instead finished its review in four months - about two months early. The injection won the accelerated FDA approval because it treats an incurable disease and the drug showed patients responded to the drug after failing on other treatments. "As a result of close collaboration among the company, the National Cancer Institute, and FDA in the development and review of the drug, FDA was able to make this novel therapy available sooner to help many thousands of patients suffering from multiple myeloma," said FDA Commissioner Dr. Mark B. McClellan. FDA approved Velcade for patients who relapsed twice while taking other medicines and who developed a resistance to their last treatment. Velcade isn't expected to be a huge money maker with only the multiple myeloma approval, since just 45,000 people in the U.S have the disease and 14,600 new cases will be diagnosed this year. Velcade is the first so-called proteasome inhibitor. The drug works by blocking the protein proteasome and in a study that looked at 188 patients, 28 of these hard-to-treat patients showed a response to Velcade. FDA based its accelerated approval on that response. The FDA will require subsequent studies that show a clinical benefit, such as keeping patients alive longer, before the drug can win full approval. The most common side effects were nausea, fatigue, diarrhea and constipation. Dow Jones Newswires