September 20, 2010 | by Actelion Pharmaceuticals Ltd
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September 20, 2010, Actelion Ltd. (SIX: ATLN) announced today that its fully owned US subsidiary Actelion Pharmaceuticals US, Inc. has received a subpoena from the United States Attorney's Office for the Northern District of California, requesting documents relating, among others, to marketing and sales practices of Tracleer in the United States. Tracleer is a prescription medication for the treatment of patients with pulmonary arterial hypertension. The company intends to cooperate with the investigation.
Notes to the Editor
About pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.
About Tracleer in Pulmonary Arterial Hypertension (PAH)
Tracleer (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.
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) - Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. High potential for major birth defects - 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 controlled distribution.
Contact
Roland Haefeli Vice President, Head of Investor Relations & Public Affairs Actelion Pharmaceuticals Ltd Gewerbestrasse 16 CH-4123 Allschwil T.: 061 565 62 62 F.: 650 624 69 36 I.: www.actelion.com
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Conclusion of this article: « Actelion Pharmaceuticals US, Inc. has received subpoena relating to Tracleer »
Source: Actelion Pharmaceuticals Ltd, Press release