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Medical Devices

New Product For Pfizer Specialty Takes Pulmonary Arterial Hypertension To Heart

Pfizer Australia announced that it has signed an agreement to acquire the local distribution rights for THELIN® (Sitaxentan sodium), an oral, once-daily highly selective endothelin receptor antagonist, indicated for the treatment of pulmonary arterial hypertension (PAH) in patients with NYHA/WHO Functional Class III symptoms to improve exercise ability. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease1. Previously distributed in Australia by CSL Limited, Pfizer"s acquisition of Encysive Pharmaceuticals in February 2008 allowed the company to acquire the global rights to THELIN, as well as Encysive"s other pipeline candidates. Primary, or unexplained, pulmonary arterial hypertension (PAH) is a rare lung disorder and has an estimated incidence of 1-2 per million population 2. According to Brad Edwards, Head of Pfizer Specialty Care Business in Australia, the introduction of THELIN further expands Pfizer"s portfolio of specialty products and will increase the company"s presence in the pulmonary hypertension area. "The addition of THELIN will complement REVATIO® (sildenafil citrate), a PAH treatment discovered and developed by Pfizer researchers, cementing the company"s commitment to furthering research and providing quality treatment for sufferers of this severe and often fatal disease", says Mr Edwards. About THELIN THELIN works by blocking the action of endothelin -1, a potent mediator of blood vessel constriction. THELIN acts to dilate the constricted blood vessels, thereby reducing pulmonary arterial pressure and thus the demands on the right side of the heart improving exercise tolerance. Thelin and Revatio are listed as Section 100 drugs on the Pharmaceutical Benefits Scheme (PBS). For full information please refer to http://www.pbs.gov.au About Pulmonary Arterial Hypertension PAH is characterised 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. In PAH, the pulmonary arteries become thickened and constricted, forcing the heart to work harder to pump blood through the lungs. Over time, the heart is unable to keep up, and blood flow and oxygenation become inadequate to meet the body"s demands. This can lead to breathlessness, fatigue, dizziness, fainting, oedema, chest pain and the development of heart failure. It may be of unknown cause (idiopathic) or secondary to other disorders such as connective tissue disease. Though relatively rare, the disease affects men and women of all races and ages, but is more common among women aged 20 through 403. The disease may be misdiagnosed as asthma, anaemia or chronic obstructive pulmonary disease. Reference 1 Thelin® (sitaxentan sodium) Minimum Product Information. (version: based on TGA approved PI March 2007 and amended 1 July 2009) 2. Public Summary Document. July 2007 PBAC Meeting. Accessible here. 3. Runo JR, Loyd JE. Primary Pulmonary Hypertension. Lancet 2003; 361: 1533-44. Pfizer Australia


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