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Biotech / Medical : CVTX - CV Therapeutics, Inc.
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From: mopgcw3/8/2007 4:20:39 PM
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mstar: CV Therapeutics' CVTX Ranexa expansion trial results were announced Tuesday, suggesting that the drug is safe but fails to effectively treat patients with acute coronary syndrome (ACS). We will be taking another look at the drug's prospects and may lower our fair value estimate slightly to account for the lost opportunity to market Ranexa to ACS patients. However, we think the results aren't all that bad. The good safety results were the most important aspect for CV Therapeutics because they could expand Ranexa's marketability to its targeted chronic angina patients. CV Therapeutics has a special protocol assessment agreement with the Food and Drug Administration that would allow Ranexa to be approved for first-line treatment of chronic angina if the drug did not cause death or arrhythmias in ACS patients. Currently only approved for a second-line chronic angina indication, Ranexa could see its market size expand from $1.2 billion to $6.5 billion, in our estimation, if the FDA holds up its end of the bargain. The drug's failure to meet its primary endpoint may still have a lasting effect on the drug's appeal to doctors and patients, however. Although the endpoints were aimed at ACS patients, doctors treating chronic angina patients could misread the trial or perceive the drug as weak. We will update our fair value estimate after we dig further into Ranexa's potential for chronic angina.
Karen Yiu
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