Tracleer Efficacious in Children for treatment of pulmonary arterial hypertension (PAH)

Actelion (Swiss: ATLN) announced yesterday that Tracleer (bosentan) has demonstrated evidence of utility in the treatment of pulmonary arterial hypertension (PAH) in children under the age of 15. According to Actelion, data from 19 children participating in the Breathe-3 open-label trial shows that administration of Tracleer leads to statistically significant improvements in measurements of circulatory system function. Several of the 19 children were also being treated simultaneously with intravenous Flolan (epoprostenol). Actelion will submit Breathe-3 results to regulatory authorities worldwide for label expansion into the pediatric population. The probability of label expansion into the pediatric population is higher than average, and would be further boosted by confirmatory hard data.

The combination of Tracleer and Flolan in adults with PAH is also being evaluated in a study named Breathe-2. Breathe-2 results should be available during the third quarter of 2002. Further clinical trials are ongoing or planned in other PAH patient populations.

Tracleer, marketed by Actelion and Genentech (NYSE: DNA), is a unique orally active endothelin receptor antagonist. Tracleer is one of three approved treatments for PAH, competing with GlaxoSmithKine's (NYSE: GSK) Flolan (epoprostenol) and United Therapeutic (NASDAQ: UTHR) and Medtronic's (NYSE: MDT) Remodulin (treprostinil sodium). Remodulin is administered subcutaneously via an infusion device. Flolan, a prostacyclin, is delivered intravenously. Tracleer was the first approved oral treatment for PAH patients and has a lower attributable cost profile than Flolan. However, Tracleer's potential adverse effects include liver damage and birth defects. Patients taking Tracleer must have monthly blood tests to catch early signs of liver damage and female patients on Tracleer need monthly pregnancy tests.

United Therapeutics' Beraprost, an oral formulation of prostacyclin, currently in phase III clinical trials, has demonstrated modest treatment effects in early stage PAH, but mounting evidence shows that intermittent oral doses do not provide consistent levels of the drug in the blood necessary to treat advanced PAH.

Pulmonary hypertension, in its primary form, strikes one or two people per million. Secondary forms of pulmonary hypertension, which are more frequently observed in the clinic, are usually adverse effects of the now-banned diet pills Redux and fen-phen or a complication of lupus and other rheumatologic disorders. Pulmonary hypertension is high blood pressure in the pulmonary (lung and related) arteries and/or pulmonary artery branches, blood vessels normally under considerably lower pressures than those of the aorta and aorta branches that go to the rest of the body. Pulmonary hypertension can lead to irreparable and devastating lung damage.

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
June 6, 2002

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