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First and Only Oral Medication Approved for Pulmonary Arterial Hypertension in HIV Patients

MONTREAL, CANADA -- July 24, 2006 -- TracleerŪ (bosentan) is now indicated by Health Canada for patients with pulmonary arterial hypertension (PAH) secondary to HIV in those who did not respond adequately to conventional therapy.

PAH is a life-threatening lung disease associated with elevated blood pressure inside the pulmonary artery. PAH patients typically present with unexplained symptoms such as fatigue, breathlessness, chest pain and fainting. People living with HIV are six to 12 times more likely to contract PAH than the uninfected population. Although there are a number of theories as to why this happens, the precise reasons remain unknown.[i]

This new indication for TracleerŪ adds another separate and difficult patient population to those PAH patients who can benefit from the drug. TracleerŪ had previously been approved in Canada for the treatment of patients with functional class III and IV (meaning a moderate to severe form of the disease) primary PAH and PAH secondary to scleroderma. It can offer significant clinical benefits including improvements in exercise capacity and a decrease in the rate of clinical worsening.

TracleerŪ is the only approved oral treatment in Canada that blocks the body's endothelin receptors. Endothelin is a substance produced by the endothelial cells that form a layer lining the blood and lymph vessels. It has the effect of narrowing the blood vessels and can also harden tissues, causing scarring. Endothelin is known to be a key component in the development of PAH.

A study evaluating the impact of starting treatment with TracleerŪ on the survival of primary PAH patients has shown that 96% of patients were alive after one year and 89% were alive after two years. This is compared to a predicted one and two year survival of 69% and 57% respectively based on National Institutes of Health (NIH) registry formula.

"It is a reassuring development that bosentan is now approved for patients who have PAH secondary to HIV, as this is a population for whom specific therapy for PAH was not available. Similar to other patients with PAH, people with HIV can become quite ill and die from their disease" said Dr. John Granton, Respirologist, Toronto General Hospital.

About Pulmonary Arterial Hypertension (PAH)
PAH is a rare and life-threatening disease characterized by abnormally high blood pressure in the pulmonary artery, the blood vessel that carries oxygen-poor blood from the right side of the heart to the lungs. In PAH, there is increased blood flow resistance in the pulmonary arteries, raising pressure and forcing the right side of the heart to work harder. The heart muscle starts to weaken, resulting in right-heart failure. There are a number of treatment options for PAH, although not yet a cure.

Important Safety Information
In clinical trials leading to the marketing approval of bosentan, approximately 11% of PAH patients receiving the drug 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 bosentan.

Tracleer is a registered trademark of Actelion Pharmaceuticals Ltd, CH-4123
Allschwil, Switzerland.

REFERENCE:
[i] http://aids-clinical-care.jwatch.org/cgi/content/full/2001/601/6, accessed January 24, 2006.


SOURCE: Actelion

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