ALLSCHWIL, Switzerland, Nov. 6, 2004 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Pink Sheets:ALIOF) today announced that the VERITAS study evaluating efficacy and safety of tezosentan in Acute Heart Failure (AHF) is being stopped for futility.
This decision, to discontinue the study, is consistent with the recommendations made by the Steering Committee and the independent Data Safety Monitoring Board (DSMB) on Saturday afternoon. At this point in time, the DSMB had performed the second planned interim analysis of data from approximately 1'300 patients enrolled until early October in VERITAS (Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study).
VERITAS evaluated mortality/morbidity and dyspnea benefits as co-primary clinical endpoints in AHF patients receiving standard therapy of care and either tezosentan or placebo. The DSMB reported that there were no safety issues in the study. Although hemodynamic effects were observed in the treatment arm and were consistent with previous studies, there was too remote a chance for the efficacy endpoints to become statistically significant within this study.
Actelion to reallocate resources to strengthen brands and R&D
Actelion will reinforce its focus on marketed brands Tracleer(r) and Zavesca(r) and will reallocate resources to further accelerate development of its broad clinical and pre-clinical pipeline.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(r), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(r) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).
For further information please contact: Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil
Investor Contact Roland Haefeli +41 61 487 34 58
+1 650 624 6936
Media Contact Peter Engel +41 61 487 36 28
+1 650 624 6996
http://www.actelion.com
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Monday, 8 November 2004,
08.00 CET / 02.00 AM EST / 07.00 GMT
Dial: +41 (0)91 610 56 00 (Europe)
+1 412 858-4600 (U.S.)
+44 207 107 06 11 (U.K.)
Webcast - Live and replay on demand
Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand.To access the webcast live, simply visit the link on our homepage http://www.actelion.com/ 5-10 minutes before the conference is due to start.
Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay on the website "Investors/Past Events."