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Biotech / Medical : CVTX - CV Therapeutics, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (219)	6/20/2005 3:53:28 PM
From: tuck	Read Replies (1) \| Respond to of 411

Risk Factor #4 comes into play today. >>PALO ALTO, Calif. (AP) -- Drug makers CV Therapeutics Inc. and Solvay Pharmaceuticals Inc. said Monday that the Food and Drug Administration has extended the deadline for deciding whether or not to approve the companies' Aceon high blood pressure drug as a means to lower heart attack risk in heart disease patients. The FDA extended the deadline by 90 days -- to Sept. 10 -- in order to allow additional time to audit data for an Aceon trial involving more than 12,000 patients. The trial is studying the risk of cardiovascular death and heart attacks in patients with stable coronary artery disease who do not have heart failure or substantial hypertension. Aceon was first approved by the FDA in 1993 to treat high blood pressure, and offers 24-hour blood pressure control with once-daily dosing. In a conference call, CV Therapeutics' Chairman and CEO Louis G. Lange said the FDA decided to extend the deadline after it conducted audits at four Solvay testing sites and came up with more violations than usual at one location. "A lot of sites often have some violations," said Lange. "It's just that this one site, which was in fact the last site to be inspected, had a lot more than usual. And I think that got the agency more focused on wanting to inspect additional sites." The FDA will now audit about 12 more sites of the study's 400 clinical locations. Lange declined to provide further details of the FDA's concerns. CV Therapeutics and Solvay reported in January that the FDA gave the drug priority review status, which generally reduces an application's processing time to within six months rather than the standard 10 months. The companies agreed in December to co-promote Aceon in the United States until 2010. Under the agreement, CV Therapeutics is responsible for brand marketing activities and forming a cardiovascular specialty sales force, and Solvay is responsible for manufacturing and distribution as well as marketing. "We continue to make progress in recruiting, hiring and training an outstanding cardiovascular sales team and we look forward to promoting Aceon to cardiovascular specialists this summer, and then leveraging the commercial experience we gain with Aceon to improve our potential launch of Ranexa in the first half of 2006," Lange said in a statement. Ranexa is the company's treatment for angina, or chest pain induced by artery blockage. CV Therapeutics said it now expects to submit the new drug application for Ranexa by the end of August -- one month earlier than previously expected. CV Therapeutics shares fell a penny to $23.26 in afternoon trading on the Nasdaq.<< Nevertheless, I am aware of your cost basis here. Congrats! Cheers, Tuck