SAN DIEGO, Nov. 16, 2005 (PRIMEZONE) -- Actelion Ltd (Other OTC:ATLN) announced today the poster presentation at the American College of Rheumatology (ACR) of results of RAPIDS-2, a placebo-controlled randomized study that evaluated bosentan (Tracleer(r)) in preventing or treating digital ulcerations in patients with systemic sclerosis.
The 188-patient study demonstrated in its first co-primary endpoint a statistically significant reduction in the occurrence of new digital ulcerations (p=0,035, first co-primary endpoint). In terms of the healing of digital ulcerations, the second co-primary endpoint, there was no significant difference between bosentan and placebo.(a)
Today, the oral dual endothelin receptor antagonist Tracleer(r) is indicated for the treatment of pulmonary arterial hypertension (PAH Functional Class III and IV in the United States, Class III in Europe) to improve exercise ability and decrease the rate of clinical worsening.
As many as 15% of people with systemic sclerosis develop PAH, making it a high risk group for this devastating condition.(b)
Digital ulcers are a common and painful complication of systemic sclerosis with approximately 30-50% of people with systemic sclerosis developing digital ulcers during their lifetime.(c)
Dr James R. Seibold, M.D., Professor of Internal Medicine at the University of Michigan in Ann Arbor, Michigan, USA and Principal Investigator of RAPIDS-2, commented: "It is encouraging to see earlier findings of RAPIDS-1 confirmed. In patients with scleroderma, preventing the occurrence of further digital ulcerations is a valid medical strategy and -- as demonstrated in these trials -- of benefit to patients."
The RAPIDS-2 findings in detail
The placebo-controlled, randomized study RAPIDS-2 (Randomized, double-blind, Placebo-controlled study with bosentan on healing and prevention of Ischemic Digital ulcers in patients with systemic Sclerosis) enrolled a total of 188 patients in 41 centers worldwide.
Patients with systemic sclerosis and at least one digital ulcer were treated with either bosentan (62.5mg bid for 4 weeks, then 125mg bid for at least 20 weeks and up to 32 weeks) or placebo.
The total number of new ulcers over 24 weeks was 1.9 plus-or-minus 0.2 for patients on bosentan versus 2.7 plus-or-minus 0.3 for patients on placebo (p=0.035).(a)
Using the SHAQ (Scleroderma Health Assessment Questionnaire) scale some improvements in items of hand function (secondary endpoint) were demonstrated in patients treated with bosentan. In particular, hand functions associated with 'dressing' (p=0.033) and 'eating' (p=0.098) showed improvement with bosentan over placebo at week 24. Pain scores, measured using the SHAQ VAS scale, were improved for bosentan patients at 12 weeks (p=0.034).1
Abstracts from ACR are available online at: http://www.abstractsonline.com/viewer/?mkey=%7BF5B9F43A%2D15A0%2D467D%2D8458%2D5DF32518B4E3%7D%20
Important information related to prescribing Tracleer(r) in the United States of America:
Indication
Tracleer(r) is indicated for the treatment of pulmonary arterial hypertension in patients with WHO Class III or IV symptoms, to improve exercise ability and decrease the rate of clinical worsening.(d)
Liver and Pregnancy Warnings
The administration of Tracleer(r) requires attention to two significant concerns:
-- Potential for serious liver injury: Liver monitoring of all
patients is essential prior to initiation of treatment and monthly
thereafter; and
-- high potential for major birth defects: Pregnancy must be excluded
and prevented by two forms of birth control; monthly pregnancy
tests should be obtained.
Full prescribing information available under www.tracleer.com or at 1-866-462-2856
References
(a) Seibold J et al. Bosentan prevents occurrence but does not speed
healing of digital ulcers in patients with systemic sclerosis
(SSc). Poster presentation L2: 552. ACR 2005.
(b) Black C. Pulmonary arterial hypertension: are we doing enough to
identify systemic sclerosis patients at high risk of this rare
condition? Rheumatology 2005; 44: 141-142
(c) Korn J. et al. Digital ulcers in systemic sclerosis-Prevention by
treatment with bosentan, an oral endothelin receptor antagonist.
Arthritis and Rheumatism 2004; 50:3985-3993
(d) Tracleer(r) Prescribing Information.
About the SHAQ scale
The Health Assessment Questionnaire (HAQ) was developed in 1978 by James F. Fries and colleagues at Stanford University and has become one of the most widely used patient-oriented outcome assessment instruments in the world. It has been used predominantly, but not exclusively to measure outcome in patients with rheumatic diseases, including rheumatoid arthritis, osteoarthritis, juvenile rheumatoid arthritis, lupus, scleroderma, ankylosing spondylitis, fibromyalgia, and psoriatic arthritis. The Scleroderma Health Assessment Questionnaire (SHAQ) is a modified version of the HAQ with additional outcome assessments specific for systemic sclerosis.
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 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 as well as Japan, 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 (Other OTC:ATLN).
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Wednesday, 16 November 2005, 7:00 p.m. CET / 10:00 a.m. PST / 6:00 p.m. GMT
Dial: +41 (0)91 610 56 00 (Europe)
+1 866 291 4166 (U.S.)
+44 207 107 06 11 (U.K.)
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".