Actelion shares plunge as Tracleer fails to meet primary endpoint in idiopathic pulmonary fibrosis

Switzerland's Actelion yesterday saw its shares plunge 16.2% to 45.90 Swiss francs, its lowest level for four years, after the company announced the initial results of BUILD-3, a clinical study evaluating the safety and efficacy of its lead product bosentan (sold as Tracleer) in patients suffering from idiopathic pulmonary fibrosis (IPF). While there was a consistent trend in favor of bosentan, the primary endpoint, reduction in morbidity/mortality, was not met (p=0.21). However, the company noted, the well characterized safety profile of bosentan was confirmed.

Jean-Paul Clozel, chief executive of Actelion, Europe's largest biotechnology company, commented: "We are naturally disappointed with this outcome. While in BUILD-3 there is a consistent trend in favor of bosentan, these findings do not support initiating regulatory proceedings."

Notwithstanding, a company spokesman stated that the news does not change the Actelion's financial targets for 2010 for sales growth of more than 10% and cash earnings before interest and taxes rising nearly 20%.