Tracleer and PPH News Actelion Ltd: Japanese Approval for Tracleer(r) in PAH
Approval for all Forms of Pulmonary Arterial Hypertension -- Pricing Discussions Ongoing -- Market Introduction Expected for Early June
ALLSCHWIL, Switerzerland, April 11, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) announced today that the Japanese Ministry of Health, Labor and Welfare has granted formal approval for Tracleer(r) (bosentan) in Pulmonary Arterial Hypertension (PAH). Tracleer(r) has been approved for patients suffering from all forms of PAH (WHO class III and IV). Actelion is currently in discussions with reimbursement authorities to finalize pricing. Actelion expects to make Tracleer(r) commercially available in Japan by early June 2005. Satoshi Tanaka, M.D. and President of Actelion Japan, commented: "Actelion is very pleased that soon Japanese PAH patients will have access to our orally available dual endothelin receptor antagonist Tracleer(r). Since its first market introduction in late 2001, Tracleer(r) has revolutionized the treatment of PAH, a serious and life-threatening disease."
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, said: "Actelion's sales and marketing organization in North America, Europe and Australia has established a strong track record of providing first-in-class medical education and support. Our well-trained and prepared 80 employees in Japan stand ready to provide the same level of service and dedication to Japanese physicians and patients." 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, Australia, Canada, Switzerland, Israel, Hong Kong, Malaysia, Singapore and Brazil as well as several other smaller territories worldwide. In Japan, Actelion obtained formal approval of Tracleer(r) in April 2005. Market introduction is expected in early June 2005. 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 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 CONTACT:
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Study shows how COX-2 drugs damage heart
May 26 (HeartCenterOnline) - Researchers at University of Pennsylvania School of Medicine believe they have uncovered another link in the chain of events that causes COX-2 inhibitors to increase the risk of heart attack.
Until 2004, COX-2 inhibitors were some of the most heavily prescribed medications in the United States for the relief of pain and inflammation. In late 2004, however, a study linked Vioxx, a leading COX-2 inhibitor, to increased risk of heart attack. Vioxx was voluntarily removed from the market by its manufacturer. Since then, other COX-2 inhibitors have been linked to heart attack, and one more (Bextra) has also been voluntarily removed from the market.
The researchers at Penn looked at COX-2 inhibitors' effect on the muscular wall of blood vessels. They found that a COX-2-derived fatty acid called prostacyclin controls the blood vessel response to stressors such as high blood pressure. By inhibiting COX-2, the drugs impair the ability of blood vessels to react to high blood pressure.
Combined with earlier research, this study may help physicians understand why COX-2 inhibitors affect the heart and raise heart attack risk even among patients who were previously at low risk.
Other studies have shown that, by suppressing prostacyclin production, COX-2 inhibitors predispose people to high blood pressure, which aggravates atherosclerosis, a condition in which the arteries gradually become clogged with plaque deposits. When the additional factor of impaired blood vessel response is added, it may help physicians better understand, and therefore manage, this class of drugs.
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