Serono to market fertility treatment in Japan

The Japanese Ministry of Health has approved Gonal-f 75 IU and Gonal-f 150 IU (follitropin alfa recombinant) for co-administration with Profasi 5000 IU (chorionic gonadotropin) to help induce sperm production in men with hypogonadotropic hypogonadism.

Gonal-f will be marketed in Japan under the brand name of Gonalef and has been accorded orphan status by the Japanese agency. It is anticipated that the therapy will be launched in the second quarter of 2006.

Male hypogonadotrophic hypogonadism reduces the production of testosterone and induces spermatogenesis disorder in the testis. In Japan, there are currently no other appropriate medicines to induce spermatogenesis in adult males.

The efficacy of Gonalef with Profasi injections was established based on the results of a Japanese pivotal clinical study in which significant improvement of spermatogenesis was observed in patients treated with the combination therapy. In addition, results of overseas clinical studies were also assessed and submitted to the Japanese authorities.

“Serono is the only company to offer a comprehensive portfolio of state-of-the art fertility medications for every stage of the process for both men and women,” said Jacques Theurillat, Serono’s deputy CEO and president of European & international sales & marketing.