About Iloprost

Iloprost (Ventavis®) is an inhaled formulation of a synthetic compound that possesses high affinity for the prostacyclin receptor (IP receptor). Iloprost has a similar pharmacological profile to endogenous prostacyclin (natural PGI2) but with greater chemical stability and longer half-life. The mechanism of action of iloprost influences all the main pathological mechanisms involved in pulmonary hypertension (Potent vasodilation, antithrombotic activity, antiproliferative activity, anti-inflammatory and antifibrotic activity).

In December 2004, the U.S. Food and Drug Administration approved Ventavis® (Iloprost) inhalation solution, developed by the Bayer Schering Pharma for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with Functional Class III or IV. CoTherix, Inc., a biopharmaceutical company based in San Francisco, USA, licensed the exclusive rights to develop and commercialize Ventavis® in the United States from Bayer Schering Pharma, which currently markets Ventavis® as first inhaled prostacyclin in Europe and other countries outside the US.

In March 2007, Actelion successfully completed the acquisition of CoTherix, Inc., thereby strengthening it’s PAH franchise by adding Ventavis® to its product offerings in the United Sates.

Current Status

Clinical development of iloprost now concentrates on a placebo-controlled study to significantly shorten the inhalation time. Initiation of this study is expected in 2008.

Supporting Studies

In March 2005, top line data of the Phase II clinical trial STEP - evaluating the safety and added benefit of iloprost inhalation solution therapy in patients with PAH already undergoing treatment with bosentan were published. The analysis of this study showed that the combination of iloprost and bosentan provided clinical benefit to patients with PAH and was well tolerated, consistent with the safety profile observed in patients receiving only iloprost.