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Gilead Announces Presentation of Long-Term Data for Ambrisentan, a,Potential Treatment for Patients With Pulmonary Arterial,Hypertension

xercise Capacity and Dyspnea in WHO Functional Class II and Class III Patients with Pulmonary Arterial Hypertension" will be presented on Wednesday, May 23 by Horst Olschewski, MD, Professor of Medicine in the Division of Pulmonology at the Medical University of Graz in Graz, Austria.

About Ambrisentan

Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. Activation of the ETA receptor by endothelin, a small peptide hormone, leads to vasoconstriction (narrowing of blood vessels) 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.

The U.S. Food and Drug Administration (FDA) recently accepted for filing and granted a Priority Review for Gilead's New Drug Application (NDA) for marketing approval of ambrisentan (5 mg and 10 mg) for the once-daily treatment of PAH. The FDA has established a target review date, under the Prescription Drug User Fee Act (PDUFA), of June 18, 2007.

As an investigational compound, ambrisentan has not yet been determined safe or efficacious in humans.

GlaxoSmithKline holds rights to commercialize ambrisentan for PAH in territories outside of the United States. A Marketing Authorisation Application (MAA) for ambrisentan was filed with the European Medicines Agency (EMEA) earlier this year.

About Pulmonary Arterial Hypertension

PAH is a debilitating 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 as the heart struggles to pump against these high pressures, causing such patients to ultimately die of heart failure. PAH can occur with no kno
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