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Tracleer(R) Shows Clinical Benefit as Combination Therapy with Sildenafil for Pulmonary Arterial Hypertension
Date:10/23/2007

stage PAH patients as a monotherapy.

About Tracleer(R) in Pulmonary Arterial Hypertension (PAH)

Tracleer(R) (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion Ltd. subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.

Tracleer requires attention to two significant safety concerns: potential for serious liver injury (including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) and high potential for major birth defects. Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. Pregnancy must be excluded and prevented by two forms of birth control; monthly pregnancy tests should be obtained. Because of these risks, Tracleer is only supplied through a controlled distribution system.

About Actelion Pharmaceuticals

Actelion Pharmaceuticals has pioneered research and development in the pulmonary arterial hypertension (PAH) disease area. More than 40,000 PAH patients have been prescribed Actelion's product Tracleer(R) (bosentan), an orally available dual endothelin receptor antagonist for patients with World Health Organization (WHO) Class III or IV PAH in the U.S., and Class III PAH in Europe. Tracleer was approved in 2001 as the first oral treatment for PAH, and is currently approved in the U.S., the European Union, and other markets worldwide. In January 2007, Actelion acquired CoTherix, Inc., whose product Ventavis(R) (iloprost) Inhalation Solution is approved and marketed in the United States for the treatment of patients with WHO Class III or IV PAH.


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SOURCE Actelion Pharmaceuticals US, Inc.
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