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

To: idos who wrote (309)	8/30/2007 3:00:31 PM
From: tuck	Respond to of 411

>>PHARMA MARKET: CV's Chest Pain Drug Ranexa Has Slow Start Last update: 8/30/2007 12:50:41 PM Wall Street once had high hopes for CV Therapeutics Inc.'s (CVTX) Ranexa, which last year became the first new drug approved for angina, or chronic chest pain, in more than 20 years. But sales have been less than heart-pounding, mainly due to lingering questions about its safety and effectiveness. CV Therapeutics recently slashed its sales force and hired a banker to explore strategic options. The company hopes Ranexa growth will accelerate if regulators revise safety information in the drug's product label. THE DRUG: Ranexa is approved to treat adults with chronic chest pain, after other anti-angina drugs have failed. Studies showed Ranexa reduced the frequency of chest-pain episodes versus a dummy pill. It's an oral tablet taken twice a day. Its active ingredient is ranolazine. Approved by the Food and Drug Administration in January 2006, Ranexa costs about $227 per 60 tablets on Walgreens.com - roughly a month's supply at typical dosing. THE OPPORTUNITY AND CHALLENGE: More than 6 million Americans have angina, which can be a symptom of heart disease. Common treatments include older medications such as nitrates. In 2002, after CV first applied for FDA approval of Ranexa, Needham & Co. predicted the drug's revenue would exceed $400 million in 2007. But FDA OK was delayed because the agency wanted more studies. Even after approval, there were concerns about whether Ranexa caused irregular heartbeats; a study published earlier this year suggested it doesn't. But the same study also showed Ranexa failed to reduce cardiovascular deaths and heart attacks when added to standard therapy for heart disease. PERFORMANCE: Below expectations. Last year, CV recorded Ranexa sales of $18.4 million, and reported $27.3 million for the first six months of 2007. LATEST SALES: $15.3 million for the quarter ended June 30, up from $1.2 million a year earlier. PRESCRIPTIONS: Total U.S. prescriptions in week ended Aug. 17 were 6,150, up from 3,585 in the first week of the year, according to Cantor Fitzgerald, which cited drug-data firm IMS Health. THE COMPETITION: Older anti-angina treatments include nitrates, such as nitroglycerin; beta blockers such as atenolol; and calcium-channel blockers such as amlodipine and diltiazem. Most are available as low-cost generics. WHAT CV THERAPEUTICS SAYS: "We are seeing consistent patient and physician satisfaction and steady revenue growth with Ranexa despite very restrictive product labeling." - CV Therapeutics CEO Louis Lange, July 30. WHAT WALL STREET SAYS: "While we believe in the long-term opportunity for a new and novel anti-anginal agent, our prospects for Ranexa sales in the near-term have diminished." - Needham analyst Mark Monane, July 31. WHAT'S NEXT: CV Therapeutics plans to ask FDA to remove cautionary language from the Ranexa product label, and to expand the approved uses to include previously untreated angina patients. The company hopes this will boost sales. CV Therapeutics also will explore a potential partnership with another drug maker to help sell Ranexa. (This column is a periodic snapshot of the market performance of selected drugs and vaccines.) -By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com<< Cheers, T uck