Update 2-CV Therapeutics says heart drug gets FDA nod
Fri Jan 27, 2006 08:31 PM ET
(Adds analyst comment, company comment, stock price, byline, previous NEW YORK)
By Deena Beasley
LOS ANGELES, Jan 27 (Reuters) - CV Therapeutics Inc. (CVTX.O: Quote, Profile, Research) on Friday said U.S. regulators approved its long-delayed drug Ranexa for treating chronic angina, the chest pain caused by an insufficient supply of oxygen to the heart.
The company's shares, which rose 3.5 percent to close at $26.08 on Nasdaq, were little changed at $25.99 in after hours trading.
The FDA approved Ranexa for patients who have not achieved an adequate response with other anti-anginal drugs, and said it should be used in combination with other treatments, such as beta blockers or nitrates, the company said.
There had been some concern that the FDA might approve the drug for an even more restricted group of patients, so the company was "very pleased" with how the patient population was defined, said John Bluth, a spokesman for CV Therapeutics.
About 25 percent of the estimated 6.4 million Americans with chronic angina have become resistant to existing drugs, said Needham & Co. analyst Mark Monane, adding "that's not too shabby for a biotech company to go after."
He estimated Ranexa sales of $40 million to $60 million this year.
Ranexa, known generically as ranolazine, will be the first drug developed in-house by CV Therapeutics to reach the market. The Palo Alto, California-based biotechnology company said the medicine should be available in pharmacies in late March.
"Patients will now have access to a new angina therapy for the first time in decades," CV Chief Executive Louis Lange said in a statement.
The company said complete prescribing information, including detailed safety and dosage information, will be available soon.
Ranexa's approval had been delayed for years over safety concerns such as fainting that appeared during clinical trials. The drug has been shown to prolong the "QT interval" -- the time it takes the heart to electrically recharge itself.
The company is currently conducting a 6,500-patient study of the drug as a treatment for acute coronary syndrome, and safety results from that study could be used to apply for FDA approval of Ranexa as a first-line therapy for angina, Bluth said.
Acute coronary syndrome occurs when a plaque inside a coronary artery suddenly ruptures and blocks blood flow to the heart muscle.
Results from that trial are expected in late 2006 or early 2007.
If the drug's label is expanded, sales could reach $500 million a year within two or three years, Monane said. (Additional reporting by Bill Berkrot and Lisa Richwine)
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