Tracleer and PPH News
Abstracts at European Congress of Rheumatology (EULAR) Highlight Positive Long-term Impact of Tracleer (bosentan) in the Treatment of PAH Associated with Systemic Sclerosis
VIENNA, Austria - June 10, 2005 - Actelion Ltd (SWX: ATLN) announced today that abstracts presented today at the Annual European Congress of Rheumatology - organized by the European League Against Rheumatism (EULAR) - show the positive impact of Tracleer® (bosentan) in treating pulmonary arterial hypertension (PAH) in patients with systemic sclerosis (scleroderma)1,2.
Data presented at EULAR considers short-term endpoints from pivotal trials on the efficacy of bosentan in patients with PAH associated with scleroderma as well as longer-term survival assessment from start of treatment to death or data cut-off. Over 12 or 16 weeks, patients treated with bosentan improved by 14.6m in the 6 min walk test while patients in the placebo group deteriorated by 22.2m. Fifty patients entered the open-label extensions of the trials (with 16% receiving add-on epoprostenol and 14% receiving epoprostenol after discontinuation of bosentan). Survival in these patients was recorded as 82% after 1 year, 66.6% after 2 years and 63.5% after 3 years.1
Dr Chris Denton, Consultant Rheumatologist at the Royal Free Hospital, London, and investigator comments: "My main goal for treatment of patients with PAH is to delay the progression of the disease. Based on this data, it indeed appears that survival in patients with PAH associated with scleroderma is improved relative to existing data we have on survival rates for untreated patients with these conditions."
As many as 15% of scleroderma patients develop PAH and the prognosis is extremely poor.3 Untreated there is a median survival of just 12 months for scleroderma patients diagnosed with PAH, according to published data.4
Safety of treatment with bosentan documented in TRAX
A sub-analysis of the TRAX (TRAcleer eXcellence Post-Marketing Surveillance Programme) data also presented at EULAR shows that bosentan is well tolerated in everyday clinical practice. The analysis of 1,017 patients with scleroderma studied between May 2002 and November 2004 provides supportive evidence for long-term safety of bosentan in patients with PAH associated with scleroderma and indicates that in daily medical practice Tracleer® has a comparable safety profile compared to its use in patients with IPAH.2
Bosentan has positive effect on complications associated with scleroderma
In addition to data presented on the treatment of PAH in patients with scleroderma, studies are being presented on the impact of bosentan treatment on digital ulcers (DUs), Raynaud's phenomenon and cutaneous fibrosis.
Three studies presented at EULAR highlight the potential for bosentan to reduce the number of digital ulcers experienced by patients with scleroderma and to prevent the occurrence of new digital ulcers.5,6,7
Two further studies suggest that treatment with bosentan may reduce the frequency and severity of episodes for patients with Raynaud's phenomenon.6,8 An additional study also highlights that in patients with cutaneous fibrosis bosentan remains effective beyond 18 months of therapy, with all 11 patients in the study experiencing improvement of CF.9
"These studies add further weight to the argument that endothelin plays an important role in scleroderma as well as its well known role in PAH. Interestingly for rheumatologists, the role that bosentan may play in preventing the occurrence of new digital ulcers is a further area to explore," said Dr Florenzo Iannone, Rheumatology Unit, University of Bari, Italy.
Tracleer® (bosentan) 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 capacity and decrease the time to clinical worsening.10 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 EULAR are available online at:
http://mcic3.textor.com/cgi-bin/mc/dq.pl?ccode=eular2005SCIE&show=TKNAS
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References
1. Denton CP, Humbert M, Rubin LJ et al. Bosentan therapy for pulmonary arterial hypertension related to systemic sclerosis: a subgroup analysis of the pivotal studies and their extensions. Poster: FRI0124. Presented at EULAR 2005
2. Denton CP, Coghlan J, Black CM et al. Long-term safety profile of bosentan in patients with systemic sclerosis and pulmonary arterial hypertension: results from the TRAX database. Poster: FRI0123. Presented at EULAR 2005
3. Magdliano M, Isenberg DA, Hillson J. Pulmonary hypertension in autoimmune rheumatic diseases. Arthritis Rheum 2002;46:1997-2009
4. Koh E, et al. Pulmonary hypertension in systemic sclerosis: an analysis of 17 patients. Rheumatology 1996; 35:989-993
5. Iannone F, Riccardi MT, Chialà A et al. Long term efficacy of bosentan in the therapy of systemic sclerosis associated pulmonary arterial hypertension. Poster: FRI0148. Presented at EULAR 2005
6. Alegre-Sancho JJ, Fernández-Llanio N, Hortal-Alonso R et al. Long-term efficacy and safety of bosentan in the treatment of ischemic digital ulcers due to severe Raynaud's phenomenon in patients with systemic sclerosis. Poster: FRI0099. Presented at EULAR 2005.
7. García de la Peña Lefebvre P, Rodriguez Rubio S, Valero Expósito M et al. Digital ulcers in systemic sclerosis: effectiveness by treatment with bosentan. Poster: FRI0161. Presented at EULAR 2005.
8. Font J, Ramos-Casals M, Nardi N et al. One-year prospective follow-up of bosentan treatment for severe Raynaud phenomenon associated with systemic sclerosis. Poster: FRI0069. Presented at EULAR 2005.
9. Alegre-Sancho J, Chalmeta-Verdejo C, Fernández-Carballido C et al. Systemic sclerosis: long-term efficacy of bosentan on cutaneous fibrosis. Poster: FRI0097. Presented at EULAR 2005.
10. Tracleer Prescribing Information
About Tracleer® in Pulmonary Arterial Hypertension (PAH) Tracleer®, 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® 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®.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® 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 61 565 64 58
+1 650 624 6936
Media Contact Peter Engel +41 61 565 66 28
+1 650 624 6996
http://www.actelion.com
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