Healthcare Industry News: TRACLEER
News Release - May 23, 2006
Actelion: ATS Presentation Highlights Strong Rationale for a Morbidity/Mortality Study with Bosentan in Idiopathic Pulmonary FibrosisSAN DIEGO, May 23, 2006 (Healthcare Sales & Marketing Network) -- Actelion Ltd (Other OTC:ALIOF) (Swiss:ATLN.SW ) announced today that data presented from the BUILD program (Bosentan Use in Interstitial Lung Disease) at the American Thoracic Society (ATS) conference provide a strong rationale to further evaluate the safety and efficacy of bosentan in a morbidity/mortality-driven Phase III study in patients suffering from idiopathic pulmonary fibrosis (IPF).
The BUILD-1 study was a double-blind, randomized, placebo-controlled, multi-center study designed to evaluate the efficacy of bosentan in improving the exercise capacity of patients suffering from IPF. Secondary endpoints -- for which the study was not powered -- included time to death and disease progression. 158 patients took part in the study, of which 154 were fully evaluable(a).
As previously communicated in November 2005, bosentan did not have a positive effect on the six-minute walk test (6MWT), but treatment with bosentan showed a positive trend for pre-defined morbidity/mortality endpoints. The combined incidence of disease progression or death up to 12 months was 36.1% in the placebo group versus 22.5% in the bosentan group, representing a relative risk reduction of 38% (p=0.076; 95% CL 37%, 105%)(a).
Full analysis of the study now presented at ATS included evaluating the treatment effect of bosentan in patients who had lung biopsy (n=99) as a proof of IPF. The analysis of this patient group, which was considered of special interest by the FDA, showed a significantly more pronounced treatment effect(a). In these patients, the combined incidence of disease progression or death up to 12 months was 38.0% in the placebo group versus 12.2% in the bosentan group, representing a relative risk reduction of 68% (p=0.005; 95% CL 14%, 74%).
The use of bosentan in the study was well tolerated with no unexpected adverse events. The observed safety profile was consistent with earlier findings in the clinical studies that led to the approval of bosentan in pulmonary arterial hypertension (PAH).
Talmadge King Jr. M.D., Professor of Medicine at UCSF, San Francisco General Hospital and Principal investigator of the BUILD-1 study, commented: ``The unexpected and very encouraging BUILD-1 findings in lung-biopsy proven IPF definitely warrant further clinical evaluation of bosentan in this indication. I am also encouraged to see that bosentan had a positive effect on the morbidity/mortality endpoint, mostly comprised of pulmonary function tests, which is a clinically important and robust endpoint.''
IPF is a progressive and serious condition with a poor prognosis. Currently, there are no approved therapies in IPF. Median survival of patients with IPF is less than 3 years(b).
Actelion is currently in advanced discussion with regulatory authorities to finalize the design and scope of a phase III mortality and morbidity study in patients with biopsy proven IPF. The company expects enrollment in the BUILD-3 program to start by the end of 2006.
Abstracts from ATS are available online at: http://www.abstracts2view.com/ats06/
Important information related to prescribing TRACLEER(r) in the United States of America:
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(c).
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 http://www.TRACLEER.com or at 1-866-462-2856.
(a) King TE, el al. Bosentan Use in Idiopathic Pulmonary Fibrosis (IPF): Results of the Placebo-Controlled BUILD-1 Study. Presented at Mini-Symposium (C13) Idiopathic Pulmonary Fibrosis on 23 May, 2006.
(b) Bjoraker JA, et al. Am J Respir Crit Care Med 1998; 157:199-203. (c) TRACLEER(r) Prescribing Information.
Note to the Editor:
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 that do not use a reliable method of contraception, must not take TRACLEER(r).
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 (Swiss:ATLN.SW ).
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