Tracleer and PPH News Source: Actelion Ltd Actelion Ltd -- Scientific Publication on Long-Term Bosentan Use in PPH European Respiratory Journal -- Outcome Data Analysis of First-Line Use of Bosentan (Tracleer) in Patients With Advanced Primary Pulmonary Hypertension -- Long-Term Benefits of Bosentan Therapy Confirmed
ALLSCHWIL, Switzerland, Feb. 1, 2005 (PRIMEZONE) -- Actelion Ltd (Other OTC:ALIOF) (SWX:ATLN) announced today the publication of the scientific paper evaluating disease outcome of patients with advanced primary pulmonary arterial hypertension receiving Tracleer(r) (bosentan). Outcome in patients receiving first-line bosentan therapy was compared to patient outcomes whose disease progression was documented in a historical database of the U.S. National Institute of Health (NIH). Commenting on the publication, lead investigator Dr. Vallerie McLaughlin, University of Michigan, Ann Arbor, MI, USA, said, "The present study suggests that the treatment of first-line bosentan therapy followed by the addition of other pulmonary arterial hypertension (PAH) therapies, if needed, improves survival in patients with advanced primary pulmonary hypertension." Dr McLaughlin added that, "Given the ease of administration and favorable side-effect profile, the strategy of treatment with first-line bosentan should be considered for World Health Organisation (WHO) functional class III primary pulmonary hypertension patients." The study "Survival with first-line bosentan in patients with primary pulmonary hypertension" by V. McLaughlin et al. has been published in the European Respiratory Journal Volume 25, Issue 2, pages 244-249. This publication supports earlier findings by Olivier Sitbon in Chest, 2003 July, Volume 124(1), pages 247-254. This shorter and smaller study had found that long-term treatment with bosentan was well tolerated and provided sustained benefits on exercise capacity and hemodynamics in patients with PAH. Additionally, recent guidelines from The American College of Chest Physicians (ACCP) published in Chest, 2004 July, Volume 126(1), pages 35S-62S by Badesch et al., now recommend bosentan as a first-line therapy for WHO Functional Class III PAH patients. The publication findings in detail A total of 245 patients with PAH were enrolled in the two placebo-controlled trials. At the end of these studies, all patients were offered bosentan therapy. The results published today are from the long-term follow-up of the 169 patients with primary pulmonary hypertension (PPH). The objective of this study was to evaluate the effect of first-line bosentan therapy followed by additional therapies if needed, on survival in PPH patients compared with NIH estimates. An additional objective was to explore prognostic factors for survival in bosentan-treated PPH patients. Patients who participated in these studies have now received bosentan as first-line therapy for up to three years. Data on survival and alternative treatments were collected from September 1999 to December 2002. Observed survival up to 36 months was reported as Kaplan-Meier estimates and compared with predicted survival as determined for each patient by the National Institutes of Health (NIH) Registry formula. In assessing the long-term benefit of bosentan, Dr. McLaughlin and her U.S. and European colleagues compared the survival in bosentan-treated patients to the survival that would have been predicted based on past clinical experience. Results showed that survival in the bosentan treated patients was 96 percent at one year and 89 percent at two years. In comparison, the expected survival without treatment was 67 percent at one year and 58 percent at two years. A significant feature of the study was that 85 percent and 70 percent of patients were still on bosentan alone, at one year and two years of follow up respectively, without the need for additional therapies. 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, Australia, Canada, Switzerland, Israel, Hong Kong, Malaysia, Singapore and Brazil. In Japan, Tracleer(r) has been filed for marketing approval. 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). About Pulmonary Arterial Hypertension (PAH) Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease. 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). CONTACT: Actelion Ltd
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Clinical trials of Encysive hypertension drug put on hold
by Mary Ann Azevedo
March 24, 2006 - Houston Business Journal - Early clinical trials of one of Encysive Pharmaceuticals' hypertension drugs has been put on hold as the company awaits a decision from the U.S. Food and Drug Administration regarding the approval status of its pulmonary arterial hypertension drug, Thelin.
Houston-based Encysive (NASDAQ:ENCY) and the FDA have placed TBC3711, the company's next-generation selective endothelin receptor antagonist entering early clinical studies, on clinical hold.
The decision was made as a result of an unusual finding following dosing with intravenous TBC3711 in a single rat that had displayed abnormalities at baseline.
The delay follows a standard 30-day review process associated with the Investigational New Drug application for the intravenous form of TBC3711.
The FDA believes that the treatment requires further review before proceeding with patient dosing.
All clinical testing with TBC3711, including oral and intravenous formulations, will be suspended.
Encysive says it will work with the FDA to resolve this issue as quickly as possible.
Meanwhile, the biotech company was expecting word Friday from the FDA on whether its pulmonary arterial hypertension drug, Thelin, will be approved.
Encysive has been in somewhat of a race with Myogen Inc. (NASDAQ:MYOG) and other pharmaceutical firms to get an effective drug to treat pulmonary arterial hypertension to market.
In December, competitor Denver-based Myogen reported positive top-line results of the first pivotal Phase III trial evaluating Ambrisentan, its pulmonary arterial hypertension drug.
Last year, Encysive successfully completed its Phase III trial to evaluate the safety and efficacy of Thelin.
Founded in 1989 by Dr. James Willerson, Encysive notched revenue of $13.8 million in 2004, but posted a net loss of $54.7 million for the year.
The company already has one product on the market, Argatroban, which is used for the treatment of heparin-induced thrombosis. GlaxoSmithKline Plc markets the drug in the U.S. and Canada.
When Argatroban received the green light in June 2000, Encysive, which was then known as Texas Biotechnology, became the first Houston company to have a drug approved by the FDA.
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