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Biotech / Medical : biotech firesales -- Ignore unavailable to you. Want to Upgrade?

To: DewDiligence_on_SI who wrote (2684)	7/27/2010 4:23:49 PM
From: Ian@SI	Read Replies (1) \| Respond to of 3661

Perhaps another FDA report on Monday accounted for some of today's loss... * JULY 27, 2010 Proposed Anticlotting Drug Raises FDA Doubts By JENNIFER CORBETT DOOREN In a review posted on its website Monday, the Food and Drug Administration questioned the effectiveness of ticagrelor, a proposed anticlotting drug developed by AstraZeneca PLC. The company is seeking FDA approval of the product to prevent heart attacks and other cardiovascular problems in patients diagnosed with acute coronary syndrome. The company has proposed a brand name of Brilinta. The drug faces a review Wednesday by the FDA's cardiovascular and renal drugs advisory committee. The panel of non-FDA medical experts is expected to vote on whether it thinks ticagrelor should be approved. Brilinta, like the market leader Plavix, is designed to keep blood platelets from sticking together in order to prevent blood clots that can lead to heart attacks and strokes. Plavix is marketed by Sanofi-Aventis SA and Bristol-Myers Squibb Co. One of the main international clinical studies compared Brilinta to Plavix in 18,624 patients who were being treated for a blocked artery or heart attack. Broadly, the results showed ticagrelor reduced the combination of heart attacks, strokes and death from cardiovascular causes by 16%, compared with Plavix, after being treated for a year. All patients received aspirin. When looking only at U.S. patients, the FDA said those patients had "worse results" with ticagrelor. The FDA said part of the reason could be that the aspirin dose was "generally higher" in the U.S. In a background document posted to FDA's website Monday, AstraZeneca said ticagrelor provides a "net benefit" over Plavix when looking at both safety and effectiveness measures.