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12:00 AM
 | 
Mar 08, 2010
 |  BioCentury  |  Strategy

Actelion hasn't seen Top of PAH

Tracleer bosentan's failure in idiopathic pulmonary fibrosis likely marks the end of potential label expansions for the drug. But Actelion Ltd. believes it can still grow the product's sales through geographical and patient expansion in its core indication of pulmonary arterial hypertension.

The company also has two more PAH candidates in Phase III testing - including a more potent follow-on to Tracleer that might succeed in IPF - as well as two Phase III compounds in other indications.

Tracleer posted CHF1.5 billion ($1.5 billion) in worldwide sales in 2009, accounting for 89% of Actelion's CHF1.7 billion ($1.6 billion) in product revenue. Although the company does not break out Tracleer sales by region, total product revenue included CHF763.5 million in the U.S., up 24% from the prior year, and CHF702.4 million in Europe, an 11% gain.

For the rest of the world (ROW), sales were CHF232.1 million, up 29% vs. the prior year.

Actelion also does not provide specific guidance for Tracleer. In February, the bitoech said it expects 2010 total revenue growth to be above 10% in local currencies.

Last week, Tracleer missed the primary endpoint of significantly reducing time to occurrence of disease worsening or death vs. placebo (p=0.21) in the double-blind, international Phase III BUILD-3 trial in 616 patients with IPF.

No further trials of Tracleer will be conducted in IPF, which was the last of several label expansions the company had hoped for. Tracleer was first approved for WHO Class III-IV PAH in the U.S. in November 2001 and in Europe in May 2002. WHO Class II PAH, a milder form of the disease, was added to both labels last year. Also last year, a pediatric formulation of Tracleer for PAH was...

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