Gilead's New Drug Application for Ambrisentan Receives Priority Review Status.PDUFA Date Set for June 18, 2007 FOSTER CITY, Calif. -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has accepted for filing and granted a Priority Review for the company's New Drug Application (NDA) for marketing approval of ambrisentan (5 mg and 10 mg) for the once-daily treatment of pulmonary arterial hypertension (PAH). Priority Review status is assigned to drug products that, if approved, would be a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The FDA goal for reviewing a drug with Priority Review is six months. Gilead submitted its NDA for ambrisentan on December 18, 2006. The FDA has established a target review date, under the Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA), of June 18, 2007. About Ambrisentan Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist A endothelin receptor antagonist (ERA) is a drug which blocks endothelin receptors. Two main kinds of ERAs exist:
va·so·con·stric·tion n. and cell proliferation. PAH is associated with elevated endothelin blood levels. Ambrisentan has been granted orphan drug designation for the treatment of PAH in both the United States and European Union. As an investigational compound, ambrisentan has not yet been determined safe or efficacious in humans. GlaxoSmithKline holds rights to commercialize ambrisentan in territories outside of the United States. About Pulmonary Arterial Hypertension PAH is a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction disease characterized by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures. These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated. Patients with PAH suffer from shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. as the heart struggles to pump against these high pressures causing such patients to ultimately die of heart failure. PAH can occur with no known underlying cause, or it can occur secondary to diseases such as connective tissue disease connective tissue disease Autoimmune disease, collagen-vascular disease Any of the diseases affecting connective tissues, with an autoimmune component, and immunologic/inflammatory defects Clinical Arthritis, connective tissue defects, endocarditis, myositis, , congenital heart defects Congenital heart defects Congenital means conditions which are present at birth. Congenital heart disease includes a variety of defects that babies are born with. Mentioned in: Heart Failure, Heart Surgery for Congenital Defects , cirrhosis of the liver Cirrhosis of the liver A type of liver disease, most often caused by chronic alcohol abuse. It is characterized by scarring of the liver, which leads to an increase in the blood pressure in the portal veins. Mentioned in: Bleeding Varices and HIV infection. PAH afflicts approximately 200,000 patients worldwide. 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
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, that are subject to risks, uncertainties and other factors, including risks related to Gilead's ability to successfully commercialize this product. For example, the FDA may not approve ambrisentan for the treatment of PAH in the United States, and marketing approval, if granted, may have significant limitations on its use. In addition, future discussions with the FDA may impact the amount of data needed and timelines for review, which may differ materially from Gilead's current projections. 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, 2005 and Reports on Form 10-Q for the first three quarters of 2006, 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. |
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