STOCKHOLM, Sweden, Sept. 5, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) announced today that two abstracts presented at the European Society of Cardiology (ESC) conference confirm the long-term safety profile of Tracleer(r) (bosentan) in treating pulmonary arterial hypertension (PAH). In a featured research session today the data focusing on PAH associated with chronic thromboembolic pulmonary hypertension (CTEPH) were presented(1). A separate presentation outlined the safety profile of Tracleer in PAH related to congenital heart disease (CHD)(2).
Both abstracts comprise data from TRAX PMS(tm), which was set up in the EU in May 2002 to collect potential safety signals associated with the use of bosentan. Between May 2002 and November 2004 almost 5,000 patients were enrolled in the TRAX PMS(tm).
Data presented from 579 European patients with PAH associated with CHD, and 470 patients with CTEPH showed that potential safety signals were recorded in 19.7% and 34.5% of patients, respectively. This compares with 36.7% seen in patients with idiopathic PAH (iPAH)(1).
"These results show that in both CTEPH and CHD patients treated with bosentan the safety profile of bosentan appeared similar with that seen in the original pivotal clinical PAH studies. This is reassuring for physicians who have patients with CTEPH and CHD requiring treatment," commented Professor Joern Carlsen from the Department of Cardiology at the Rigshospitalet in Copenhagen and key investigator involved in TRAX PMS(tm).
CTEPH is a serious condition characterised by long-standing obstruction of the large pulmonary arteries, leading to impairment of normal blood flow through the lungs. This induces hypoxaemia and pulmonary hypertension, eventually leading to respiratory insufficiency and right heart failure. In selected cases, CTEPH is treated through a complicated procedure called a pulmonary thromboendarterectomy performed under hypothermia and total circulatory arrest. In some patients it is too risky or not feasible to perform this surgery.
Congenital heart disease is an abnormality in the heart's structure and function caused by abnormal or disordered heart development before birth. CHD affects almost 1% of liveborn infants(4) and is a broad term that can describe a number of different abnormalities affecting the heart including Eisenmenger's Syndrome, aortic stenosis and atrioventricular canal defect. Approximately 15% of patients with CHD develop PAH(1).
Bosentan (Tracleer(r)) is an oral treatment for PAH (Class III and IV in the United States, Class III in Europe) and the only one shown to improve exercise ability and decrease the rate of clinical worsening(5). Bosentan is a dual endothelin receptor antagonist (ERA). It works by comprehensively blocking the binding of endothelin (ET) to both of its receptors ETA and ETB, thereby preventing the deleterious effects of ET.
Abstracts from ESC are available online at: http://www.escardio.org/congresses/esc_congress_2005/
References
1. Carlsen J et al. Long-term safety profile of bosentan in patients
with chronic thromboembolic pulmonary hypertension (CTEPH):
results from the TRAX PMS(tm) database. Abstract number: 85720,
ESC 2005.
2. Carlsen J et al. Clinical experience with bosentan for the
treatment of pulmonary hypertension associated with congenital
heart disease, Abstract number 85143, ESC 2005.
3. Rubin L et al. Bosentan therapy for pulmonary arterial
hypertension. NEJM, 2002. 346, 12: 896-903.
4. Day I, Wilson D. Genetics and cardiovascular risk. BMJ
2001;323:1409-1412.
5. Tracleer Prescribing Information.
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).
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