ALLSCHWIL, Switzerland, April 8, 2003 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) today announced that the company has submitted a new drug application (NDA) for Tracleer(R) for the treatment of pulmonary arterial hypertension (PAH) with the Japanese health authorities.
Tracleer(R), an orally available dual endothelin receptor antagonist, is already available in key markets worldwide, including the United States, the European Union, Canada and Switzerland. In Australia, the drug has been approved and the reimbursement review is ongoing.
The NDA in Japan also reports -- in addition to the two registration studies already published(1) -- three successfully concluded bridging studies, indicating that the drug shows comparable safety and efficacy in Japanese patients.
Dr. Satoshi Tanaka, President Actelion Pharmaceuticals Japan Ltd, commented: "I am very pleased that our investment in a fully-fledged Actelion organization in Japan has allowed us to rapidly translate and adapt the original NDA. We are fully prepared to answer any questions the Japanese health authorities might have in the upcoming review process."
In Japan, Tracleer(R) has been granted Orphan Drug status earlier in the year. This allows the Japanese health authorities to review the NDA applying a fast track procedure. Accordingly, Actelion Japan already employs 25 Japanese professionals in the areas of Drug Development, Drug Safety, Drug Regulatory Affairs and Quality Assurance. The company has also started to hire additional personnel in Marketing.
In line with the progress of the NDA review, Actelion Japan will complete its sales force organization to fully serve the Japanese PAH market.
About PAH and important prescribing information
Approximately 100,000 people in Europe and the United States are afflicted with either primary pulmonary arterial hypertension or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS, congenital heart disease or the use of certain appetite suppressants.
The first signs of the disease, such as mild shortness of breath, fatigue and difficulty exercising, are so subtle that the disease is often either misdiagnosed or not diagnosed until the patient's condition is far advanced. The survival rate for PAH in untreated patients is only 40 to 55 percent at two years from the onset of symptoms. Once patients reach more advanced stages of PAH (WHO Class III and IV), they often have no choice but to go on epoprostenol sodium therapy, which requires a 24-hour infusion pump and an intravenous line implanted through the chest directly into the patient's heart. Ultimately, many patients require lung transplantation.
In the two pivotal clinical studies, 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 woman of childbearing age who do not use a reliable method of contraception, must not take Tracleer(R).
Note to the editor
Actelion will release its Q1 2003 results on Tuesday, April 29, 2003, 07.30 hrs Swiss time and not as previously announced on May 6, 2003.
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 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 Media Contact Peter Engel +41 61 487 36 28 Investor Contact Roland Haefeli +41 61 487 34 58 +1 650 624-6936 http:// www.actelion.com
(1) Channick, R.N., Simonneau, G. Sitbon, O., et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary arterial hypertension: a randomized placebo-controlled study. The Lancet 358, 1119-1123 (2001).
Rubin, L.J., Badesch B.D., Barst, R., et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med 346 (12), 896-903 (2002).