ALLSCHWIL, Switzerland, June 8, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) announced today that Tracleer(r) (bosentan) is now available upon prescription to all patients in Japan. In early April, the Japanese Ministry of Health, Labor and Welfare had granted formal approval of Tracleer(r) for the treatment of all forms of Pulmonary Arterial Hypertension PAH (WHO class III and IV). In early June, the same authority has granted full reimbursement status for this orally available dual endothelin receptor antagonist. Tracleer(r) is being made available in Japan through Actelion's own affiliate, with initially 35 territory managers focusing on hospital-based physicians.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, said: "With today's launch in Japan, Actelion has realized its strategic goal of commercializing Tracleer(r) with its own infrastructure in all key pharmaceutical markets worldwide. We can now further leverage our worldwide capabilities in clinical development, regulatory affairs and marketing and sales with new innovative compounds from our own drug discovery efforts or, should the opportunity arise, from in-licensed or acquired drugs."
Satoshi Tanaka, Dr med Sci, and President of Actelion Japan, commented: "Since Actelion Japan has been founded in October 2001, we have built a fully government-certified affiliate. By having documented our professionalism, the Japanese authorities have gained the necessary confidence not only in Tracleer(r) and its clinical benefits, but also in Actelion's capabilities to responsibly promote Tracleer(r) in Japan. We are ready to ensure that Japanese physicians and patients are receiving the same level of service and support as Actelion has successfully established already in North America and Europe."
Dr. Tanaka concluded: "By having conducted a local clinical trial -- bridging to the results of the international Phase 3 clinical trials -- we have generated initial clinical development and regulatory expertise to support the global clinical development of future Actelion compounds."
About Tracleer(r) in Pulmonary Arterial Hypertension (PAH)
Tracleer(r), 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.
In clinical trials leading to the marketing approval of the drug, approximately 11% of PAH patients receiving Tracleer(r) experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or of childbearing age who do not use a reliable method of contraception, must not take Tracleer(r).
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.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters 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, Japan 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 (SWX:ATLN).
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Wednesday, 8 June 2005, 12.00 CET / 06.00 a.m. EST / 11.00 BST / 19.00 JST
Dial: +41 (0)91 610 56 00 (Europe)
+1 (1) 866 291 4166 (U.S.)
+44 207 107 06 11 (U.K.)
00531 121 266 (Japan)
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".