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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

SOUTH SAN FRANCISCO, Calif. and ALLSCHWIL, Switzerland, June 20 /PRNewswire/ -- Actelion Ltd (SWX: ATLN) announced today that data published in The Lancet(1) show that, in mildly symptomatic pulmonary arterial hypertension (PAH) patients (WHO functional class II - WHO FC II), bosentan (Tracleer(R)) prevented clinical deterioration by significantly delaying time to clinical worsening and reduced the number of patients worsening to WHO FC III/IV. A significant reduction in pulmonary vascular resistance and a positive trend in increasing the 6MWD were also observed. The randomized, placebo-controlled EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) trial is the first and only trial conducted exclusively in a dedicated FC II PAH patient population.

Professor Nazzareno Galie of the University of Bologna, Italy and lead investigator commented: "The EARLY trial demonstrates that without treatment, even mildly symptomatic patients experience PAH progression within a short period of time. In contrast, treatment with bosentan significantly delayed PAH progression while improving hemodynamic parameters."

The findings of EARLY indicate that treatment with bosentan may be beneficial for WHO FC II PAH patients. Actelion is working with authorities in the US and Europe and in other countries worldwide to expand the label for Tracleer(R) to include WHO FC II.

EARLY is the third randomized controlled trial with bosentan, to provide data that show a consistent significant effect on delaying PAH progression and reducing disease severity. The data from the other two pivotal trials, Study 351(2) and BREATHE-1(3) trial, which both investigated bosentan in FC III and IV patients, were published in The Lancet and the New England Journal of Medicine respectively.

The objectives of the EARLY trial were to investigate the effects of bosentan specifically in PAH patients in WHO FC II and to gain more insight into early stage disease. The
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SOURCE Actelion Ltd
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