AUXILIUM DISCONTINES DEVELOPMENT OF TESTOFILM

Auxilium Pharmaceuticals has announced it is discontinuing the development of the current formulation of TestoFilm, its testosterone replacement transmucosal film product candidate for the treatment of hypogonadism. The company has been conducting a Phase III comparative study in the U.S. and a Phase III safety study in Europe for TestoFilm.

Based on a recent evaluation, the company has determined that the current formulation of TestoFilm does not meet certain critical aspects of the target product profile and, as a result, would not be commercially viable. No safety-related issues with the preliminary findings from the Phase III trials prompted the decision. The company believes that the transmucosal film delivery system is viable and intends to develop opportunities in hormone replacement, urologic disease and pain.

The company also announced it expects to begin a second Phase III pivotal trial of AA4500, an injectable enzyme, for the treatment of Dupuytren's Contracture by the end of 2006. The company has a focus on developing and marketing products for urology, sexual health and other indications within specialty markets.