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Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease
Date:6/20/2008

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

Tracleer(R) is an oral dual endothelin receptor antagonist, which is currently licensed for the treatment of PAH; in the United States in PAH Functional Class III and IV to improve exercise capacity and decrease the rate of clinical worsening and in Europe in PAH Functional Class III to improve exercise capacity and symptoms. In the EU Tracleer(R) is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease. Regulatory review for the inclusion of functional class II in the Tracleer(R) label is ongoing on a worldwide basis.

Actelion also conducted clinical trials to further describe the role of bosentan in treating PAH in specific patient populations, such as patients with congenital heart disease (with Eisenmenger syndrome; BREATHE-5), patients infected with HIV (BREATHE-4). Study results are reflected in the Tracleer(R) product label. A clinical study with bosentan in children suffering from PAH (BREATHE-3) has resulted in the ongoing clinical evaluation of a specific children formulation of bosentan.

Tracleer(R) has been made commercially available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide since 2001. In these six years of clinical experience, more than 50,000 patients have been treated with Tracleer(R).

About Tracleer(R) in Digital Ulcers (DU)

DUs are a manifestation of the underlying vasculopathy which is central to the pathophysiology of systemic sclerosis (SSc) and pivotal in the development of PAH in SSc, one of the leading causes of death in SSc. Endothelin, a pathogenic mediator, is implicated in the underlying vasculopathy in SSc.

DUs can be a frequent, persistent and debilitating complication of SSc. They are caused by a reduction in the lumen of small bloody vessels that decreases blood flow
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SOURCE Actelion Ltd
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