Washington Editor

The FDA approved a wider label for Aceon (perindopril erbumine), a cardiovascular drug marketed in part by CV Therapeutics Inc. through a partnership that has laid the groundwork for eventual sales of another of its drugs, Ranexa.

"The expansion significantly increases the potential market opportunity for Aceon," John Bluth, the company's senior director of corporate communications, told BioWorld Today. "The prospect of the expanded label was certainly very attractive to us when we entered this co-promotion agreement."

Aceon's new indication is for treating patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infarction. Previously in the U.S., Aceon was labeled solely for essential hypertension, with peak sales topping out at about $30 million per annum. That contrasts with Europe, where the once-daily tablets have been sold under a different name, Coversyl, for the broader indication, and sales have reached about /500 million.

The Palo Alto, Calif.-based company's involvement with Aceon dates to the end of last year when it entered a co-marketing arrangement in the U.S. with Solvay Pharmaceuticals Inc. For CV Therapeutics, this product release represents an opportunity to more broadly unveil its newly recruited sales force and reach out to cardiovascular specialists, a group to whom the drug was barely detailed in the past.

"We feel that additional promotion to cardiology specialists, combined with a substantially expanded label," Bluth said, "provides a significant amount of upside to the existing sales level."

And shortly down the road, the company expects those same 150 to 200 salespeople to cover the same ground for the angina drug, Ranexa (ranolazine), for which an amendment to its new drug application was recently submitted. Earlier this year, that drug met a Phase III primary endpoint in reducing weekly angina frequency compared to placebo (p=0.028). That study was conducted under a special protocol assessment with the FDA; regulatory action is expected by the end of January. (See BioWorld Today, April 19, 2005.)

"From a timing perspective, it really coordinates nicely with the potential approval of Ranexa in the first half of next year," Bluth said. "We continue to see a lot of synergies."

Aceon's new indication is based on a massive European trial that tested its ability to reduce cardiac events in older and younger patients with stable coronary artery disease. Called EUROPA, the multicenter, randomized, double-blinded, placebo-controlled trial included 12,218 participants who were followed for a mean of 4.2 years. Data showed a 20 percent reduction in the combined endpoint of cardiovascular mortality, non-fatal myocardial infarction and cardiac arrest compared to placebo (p=0.0003).

The relative risk reduction was seen in patients treated with 8 mg of Aceon, an ACE inhibitor, including those already on conventional cardiovascular preventive therapy such as aspirin, other anti-coagulants, beta-blockers and other anti-hypertensive therapy, as well as lipid-lowering therapy such as statins.

The deal with Solvay, of Marietta, Ga., involved no up-front payments and calls for CV Therapeutics to handle brand marketing and promotional activities. Solvay, part of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium, will continue to handle manufacturing and distribution, and its primary care sales force also will continue its promotional work. Solvay books all sales, and CV Therapeutics will receive an average 50 percent to 60 percent share of sales above an unspecified baseline.

For CV Therapeutics, the future also looks bright on another front in its portfolio, regadenoson, which has been evaluated for use as a pharmacologic stress agent in myocardial perfusion imaging studies. Findings released earlier this month showed that such imaging work demonstrated a 95 percent confidence that it was comparable to the leading agent for such studies. (See BioWorld Today, Aug. 12, 2005.)

Data from a second Phase III trial are expected by the end of this year, Bluth said, with a regulatory filing anticipated next year and a regulatory decision about a year later. Should it receive approval, U.S. sales would be handled by Astellas Pharma Inc., of Deerfield, Ill., with royalties due back to CV Therapeutics. Elsewhere in its pipeline, the company recently began Phase I studies of CVT-6883 for asthma.

"It's been a very active few months," Bluth said.

On Wednesday, CV Therapeutics' shares (NASDAQ:CVTX) gained 34 cents to close at $27.28.

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