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Regadenoson Meets Primary Endpoint in First Phase 3 Trial

PALO ALTO, Calif. and DEERFIELD, Ill., Aug. 10 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) and Astellas Pharma US, Inc. announced today that the first of two pivotal Phase 3 studies of regadenoson met its primary endpoint.

The study met its primary endpoint by showing with 95 percent confidence that myocardial perfusion imaging (MPI) studies conducted with regadenoson were comparable to MPI studies conducted with Adenoscan(R). Adenoscan(R) is the leading agent for MPI studies in the United States and is marketed by Astellas.

This multinational, randomized, double-blind pivotal Phase 3 study of 784 patients undergoing MPI studies was designed to evaluate the comparability of MPI studies conducted with regadenoson and Adenoscan(R). Regadenoson was generally well tolerated. In this study, the most common adverse events reported in patients who received regadenoson were headache, chest pain, shortness of breath, flushing and gastrointestinal discomfort.

The company plans to present the study results at a future scientific conference.

"We are very pleased with the success of regadenoson in this study and look forward to receiving the results from our other Phase 3 trial, which has the same study design. If successful, we plan to submit a new drug application for regadenoson to the FDA," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.

"If approved by the FDA, regadenoson would represent an important new option for the growing population of patients in the United States who are in need of myocardial perfusion imaging studies," said Makoto Nishimura, Ph.D., president and chief executive officer of Astellas Pharma US, Inc.

Regadenoson is a selective A2A-adenosine receptor agonist for potential use as a pharmacologic stress agent in MPI studies. Regadenoson has been designed to be delivered rapidly as a bolus and to selectively stimulate the A2A-adenosine receptor, the receptor responsible for coronary vasodilation.

Under a collaboration agreement providing Astellas with exclusive North American rights to regadenoson, CV Therapeutics manages the clinical development program and Astellas is responsible for manufacturing, selling and marketing regadenoson in North America, if the product is approved for marketing. Under the arrangement, Astellas reimburses CV Therapeutics for 75 percent of development costs and CV Therapeutics will receive a royalty on product sales of regadenoson, if approved, and may receive a royalty on another product. CV Therapeutics owns the rights for regadenoson outside of North America.

Myocardial perfusion imaging studies
MPI studies help detect and characterize coronary artery disease by identifying areas of poor blood flow in the heart. In 2002, approximately 7.8 million patients underwent MPI studies in the United States.

Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, more than 40 percent of the patients undergoing an MPI study are unable to exercise adequately because of medical conditions such as peripheral vascular disease, arthritis or other limiting medical conditions which prevent them from exercising on the treadmill. For these patients, a pharmacologic agent that temporarily increases coronary blood flow is used to mimic the increase in coronary blood flow caused by exercise. Regadenoson is being studied for potential use as a pharmacologic agent under these circumstances.

Source: CV Therapeutics, Inc.

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