Phase III Data for Gilead Sciences' Darusentan Accepted as Late-Breaker Presentation at ASH 2009
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr 13, 2009 - <!-- cpurl -->Gilead Sciences<!-- /cpurl -->, Inc. (Nasdaq:GILD) today announced that data from DAR-311 (DORADO), a Phase III clinical trial evaluating the company's endothelin receptor antagonist (ERA) <!-- ppurl -->darusentan<!-- /ppurl -->for the treatment of resistant hypertension, have been accepted as an oral late-breaker presentation at the American Society of Hypertension, Inc. (ASH) Twenty-Fourth Annual Scientific Meeting and Exposition (ASH 2009) in San Francisco, May 6-9.
The abstract titled, “Fixed Doses of Darusentan Compared to Placebo in Treatment Resistant Hypertension” (Presentation# LB-OR-06), will be presented by Michael A. Weber, MD, Professor of Medicine at the SUNY Downstate Medical College of Medicine, Brooklyn, New York, at 4:30 p.m. PDT on Friday, May 8 during the Late-Breaking Clinical Trials session.
Darusentan is a propanoic-acid class endothelin receptor antagonist (ERA) being investigated in clinical trials as an add-on oral therapy for patients with resistant hypertension. Darusentan selectively blocks the endothelin type-A (ETA) receptor, which if activated by endothelin-1 (ET-1), leads to vasoconstriction (narrowing of blood vessels) and cell proliferation. Elevated ET-1 blood concentrations have been reported in some patients with hypertension, including several subgroups of hypertensive patients that have been historically difficult to treat.
Darusentan is an investigational compound and has not yet been determined safe or efficacious in humans.
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 risk that the safety and efficacy data obtained from the DAR-311 (DORADO) clinical trial will not be observed in other clinical trials. In addition, feedback from regulatory authorities or results from clinical trials might result in delays or require additional trials to be performed. As a result, we may cease development of darusentan for the treatment of resistant hypertension. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2008 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 www.gilead.com.
Contact: Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Nathan Kaiser, 650-522-1853 (Media)
Posted: April 2009