Gilead Sciences' Marketing Authorisation Application for Regadenoson Validated by European Medicines Agency

FOSTER CITY, Calif.--(BUSINESS WIRE)--May. 28, 2009-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by the European Medicines Agency (EMEA). Following validation of the MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review to determine whether regadenoson is a safe and efficacious pharmacologic stress agent in humans.

The submission includes data from two identically designed Phase III clinical trials, which showed with 95 percent confidence that MPI studies conducted with regadenoson were similar to MPI studies conducted with Adenoscan® (adenosine injection). Regadenoson was generally well tolerated in both Phase III studies. The most common adverse events reported in patients who received regadenoson were shortness of breath, headache, flushing, chest discomfort, dizziness and nausea.

About Regadenoson

Regadenoson is a selective A2A adenosine receptor agonist developed for use as a pharmacologic stress agent in MPI studies. Regadenoson has been designed to be delivered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight, and to selectively stimulate the A2A adenosine receptor, the receptor responsible for coronary vasodilation.

Regadenoson is approved by the U.S. Food and Drug Administration and is commercialized in the United States by Astellas Pharma US, Inc. under the tradename Lexiscan®. Gilead retains all rights to regadenoson outside of North America.

About Myocardial Perfusion Imaging

Myocardial perfusion imaging (MPI) tests, commonly called cardiac stress tests, identify areas of poor blood flow in the heart to help detect and characterize coronary artery disease, the most common type of heart disease. Many patients exercise on a treadmill to generate the increase in coronary blood flow necessary to perform an MPI study. However, almost half of the patients undergoing cardiac stress tests each year are unable to exercise adequately because of medical conditions. For these patients, a pharmacologic stress agent that temporarily increases blood flow through the coronary arteries is used to mimic the increase in coronary blood flow caused by exercise.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risks that, following its review, the CHMP will not approve regadenoson as a pharmacologic stress agent, which may cause considerable expense and may lead to delays or cause Gilead to abandon further development of the product. As a result, regadenoson may never be successfully commercialized in the European Union. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2008 and its Quarterly Report on Form 10-Q for the first quarter of 2009, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead, please call the Gilead Public Affairs Department at
1-800-GILEAD-5 (1-800-445-3235) or visit

Adenoscan and Lexiscan are registered trademarks of Astellas Pharma US, Inc.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)