Zulassung für Australien ist da ! Die Thelin - Story ! - 500 Beiträge pro Seite

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http://biz.yahoo.com/pz/070307/115029.html

THELIN (sitaxentan sodium) Receives Australian Marketing Approval
Wednesday March 7, 5:00 am ET
First Selective, Once Daily Oral Endothelin A Receptor Antagonist Approved by Australian Health Authority

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Encysive Pharmaceuticals Announces Launch of THELIN (Sitaxentan Sodium) in the Netherlands
Monday April 16, 2:00 am ET
First Selective, Once-Daily Oral Endothelin A Receptor Antagonist Now Commercially Available for Pulmonary Arterial Hypertension Patients

HOUSTON, April 16, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced the commercial availability of THELIN(r)(1) (sitaxentan sodium(2)) 100 mg tablets in the Netherlands for the treatment of pulmonary arterial hypertension (PAH). The Company received European Union marketing authorization for THELIN from the European Commission in August 2006. THELIN is the first selective endothelin A receptor antagonist and the first once-daily oral treatment available for patients with PAH.

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THELIN is indicated for improving exercise capacity in PAH patients classified as World Health Organization (WHO) functional class III. Efficacy has been shown in primary pulmonary hypertension(3) and pulmonary hypertension associated with connective tissue disease (CTD).

``As a once-daily oral therapy, THELIN may provide PAH patients with effective symptom management in a convenient, non-invasive route of administration,'' said Anco Boonstra, M.D., Ph.D., pulmonologist, Vrije Universiteit Medical Center, Amsterdam. ``THELIN is a welcome new treatment option for patients with primary disease and also those with CTD-related PAH, where THELIN has demonstrated a therapeutic benefit.''

The European Commission's centralized licensing procedure permits Encysive to market THELIN in all 27 member states of the European Union. THELIN has been launched in three member states to date, and will be commercialized in successive EU countries as local government approval for reimbursement is obtained.

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Hurra, die Zulassung in Kanada ist da. Kurs bereits vorbörslich um 25% gestiegen :


After Hours: 4.50 Up 0.91 (25.35%) as of May 30 on 05/30/07

Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension
Wednesday May 30, 5:46 pm ET
First Selective Endothelin A Receptor Antagonist, First Once-Daily Oral Treatment

HOUSTON, May 30, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced that Health Canada's Therapeutic Products Directorate has approved THELIN(tm) (sitaxsentan sodium) 100 mg tablets.

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Canadian Health Authority Approves THELIN (Sitaxsentan Sodium) for Pulmonary Arterial Hypertension
Wednesday May 30, 5:46 pm ET
First Selective Endothelin A Receptor Antagonist, First Once-Daily Oral Treatment

HOUSTON, May 30, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (NasdaqGM:ENCY - News) today announced that Health Canada's Therapeutic Products Directorate has approved THELIN(tm) (sitaxsentan sodium) 100 mg tablets.

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THELIN is indicated for the treatment of primary pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to connective tissue disease, in patients with World Health Organization (WHO) functional class III who have not responded to conventional therapy. THELIN is also indicated in patients with WHO functional class II who did not respond to conventional therapy and for whom no appropriate alternative can be identified.

THELIN is the first selective endothelin A receptor antagonist (ETRA) available, and the only once-daily oral treatment approved for PAH.

PAH is estimated to afflict approximately 100,000 to 200,000 people in North America and Europe. The disease is characterized by high blood pressure and structural changes in the walls of the pulmonary arteries, the blood vessels that connect the right side of the heart to the lungs. As these arteries become increasingly constricted, blood flow and oxygenation may be inadequate to meet the body's demands. The heart must then pump harder to overcome the resistance, and patients become susceptible to heart failure.

``The approval of THELIN represents an advance in the treatment options available for PAH patients in Canada,'' commented David Langleben, M.D., Professor of Medicine, McGill University and Director of the Center for Pulmonary Vascular Disease, Jewish General Hospital, Montreal. ``THELIN's safety and efficacy profile and once-a-day oral formulation make it an attractive therapeutic option, and I look forward to its commercial availability.''

``THELIN has demonstrated a unique benefit for individuals who have developed PAH as a result of a connective tissue disease, such as scleroderma,'' said Janet Pope, M.D., Professor of Rheumatology, University of Western Ontario and Director, Division of Rheumatology, St. Joseph's Health Centre, London, Ontario. ``As a clinician, I welcome any new treatment that may help these particular patients, as they are a more difficult group to treat.''

THELIN's approval is based on the largest database of patients with PAH ever assembled in an original Canadian New Drug Submission, with more than 1,000 PAH patients receiving THELIN. Encysive received European Union marketing authorization for THELIN in August 2006, marketing approval from the Australian Therapeutic Goods Administration in March 2007 and the drug is currently under evaluation by the Food and Drug Administration (FDA) in the United States.

``This approval is another important step in our effort to commercialize THELIN worldwide,'' stated Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. ``We're extremely proud to have achieved this milestone and look forward to bringing THELIN to PAH patients in Canada.''

THELIN(tm) (Sitaxsentan Sodium) Canadian Marketing Authorization Highlights

The Canadian market authorization was based on submitted data from quality (chemistry and manufacturing) studies, as well as data from non-clinical and clinical studies. Two randomized, double-blind, multi-centre, placebo-controlled studies (n=425) were conducted to demonstrate efficacy and safety. Compared to placebo, treatment with THELIN resulted in a significant increase in exercise capacity. The placebo-corrected increases in six-minute walk distance compared to baseline were 35 meters and 31 meters for the two pivotal studies. Compared to placebo-treatment, THELIN demonstrated improvements to the cardiac index, pulmonary vascular resistance, and systemic vascular resistance after 12 weeks of treatment. Compared to placebo-treatment, THELIN improved functional class. A significant reduction in the rate of clinical worsening was also reported in patients treated with THELIN.

In the STRIDE program, THELIN 100 mg was shown to significantly improve exercise capacity, as measured by improvement in six-minute walk distance, including in patients with connective tissue disease. THELIN was also shown to reduce patients' PAH symptoms (improvement in WHO/NYHA functional class) and improve PAH hemodynamic status. Survival of patients was 96% at one year in the overall patient population and 98% in patients with PAH secondary to connective tissue disease.