West Coast Editor

CV Therapeutics Inc.'s regadenoson to boost coronary blood flow for better myocardial perfusion imaging hit the primary endpoint in the first of two pivotal Phase III studies, and the company is awaiting results from the second trial.

The company's stock (NASDAQ:CVTX) closed Thursday at $26.48, up 65 cents.

"We obviously need to report results in the second Phase III, which is the same study design," Louis Lange, CEO of the Palo Alto, Calif.-based company, said during a conference call. If that second trial also proves positive, a new drug application would be filed "sometime next year," he said.

The first trial, though not designed to show "p" values, demonstrated with 95 percent confidence that MPI work done with the selective A2A adenosine receptor agonist regadenoson were comparable to those conducted with Adenoscan (adenosine), the leading agent for MPI studies in the U.S., marketed by CVT's partner Astellas Pharma Inc., of Deerfield, Ill.

"Adenoscan last year sold over $300 million [in the U.S.] and it's still a market that's growing quite actively, 15 percent or more per year," Lange said.

Regadenoson, because it is more selective, could bring fewer side effects - and did meet a "key secondary endpoint" related to tolerability as compared to Adenoscan, though Lange declined to be more specific until data are formally presented at an upcoming scientific conference.

Regadenoson, he said, was generally well tolerated in the study, which involved 784 patients, with the most common adverse events listed as headache, chest pain, shortness of breath, flushing and gastrointestinal discomfort.

MPI studies help detect and characterize coronary artery disease by identifying areas of poor blood flow in the heart. Many patients exercise on a treadmill to make the blood flow faster, but more than 40 percent cannot because of medical conditions such as peripheral vascular disease or arthritis, and they need a drug to make it happen temporarily.

Astellas is a subsidiary of Tokyo-based Astellas Pharma Inc. (Formerly Fujisawa Pharmaceutical Co. Ltd.) Under the terms of the collaboration with CVT, Astellas gets exclusive North American rights to regadenoson. CV Therapeutics manages the clinical development program and Astellas will be responsible for manufacturing, selling and marketing the drug in North America. CV Therapeutics, which owns rights outside North America, is reimbursed for 75 percent of development costs plus royalties. (See BioWorld Today, Oct. 30, 2003.)

Analysts in New York seemed happy about the trial news. Needham & Co. kept its "strong buy" rating and raised the target price from $30 to $35. Piper Jaffray, with an "outperform" ranking, upped the target price from $30 to $34. First Albany's target price is $36, with a "strong buy" rating.

Regadenoson, patent protected "into 2019," Lange said, is one of three products in late-stage development by CVT. The others are Aceon (perindopril erbumine) tablets and Ranexa (ranolazine).

In June, CVT and Solvay Pharmaceuticals Inc., of Marietta, Ga., said the FDA extended the PDUFA date for the Aceon supplemental new drug application by 90 days to allow additional time for clinical site audit activities. The PDUFA date now is Sept. 10. Aceon, marketed for hypertension, is an angiotensin-converting enzyme inhibitor, and Solvay is seeking an expansion of the drug's labeling based on trials testing it to reduce cardiovascular mortality, nonfatal myocardial infarction and cardiac arrest.

Late last month, CVT submitted to the FDA an amendment to the new drug application for Ranexa for chronic angina in a restricted patient population. The amendment is intended to provide a complete response to the approvable letter received in October 2003, and is based on a recently completed trial that met its primary endpoint and was conducted under the FDA's special protocol assessment. If approved, Ranexa could be launched in the first half of 2006. (See BioWorld Today, April 19, 2005.)

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