UTHR's Beraprost fails Phase III

United Therapeutics (UTHR) said a 750-patient U.S. Phase III trial of its beraprost oral synthetic prostacyclin analog to treat intermittent claudication (pain when walking) from peripheral vascular disease (PVD) did not confirm positive results from an earlier European Phase III trial. As a result, UTHR said it expects to halt development of beraprost for this indication, but will continue a Phase III study of the compound to treat pulmonary arterial hypertension (PAH).

In the U.S. trial, the company said there was a trend toward fewer cardiovascular events, but statistical significance was not achieved on the trial's exercise endpoints. In contrast, data from a 422-patient European trial conducted by Hoechst Marion Roussel, now apart of Aventis (AVE), showed beraprost significantly improved patients' ability to walk without pain, the study's primary end point. AVE holds European rights to beraprost from Toray Industries (Osaka, Japan) and UTHR has rights to beraprost in the U.S. and Canada from Toray. ...