Serono's Gonal-f approved in Japan for treatment of male hypogonadotropic hypogonadism

By E. Janene Geiss

Philadelphia, Jan. 24 - Serono announced Tuesday that the Japanese Ministry of Health, Labor and Welfare has approved Gonal-f 75 IU and Gonal-f 150 IU (follitropin alfa recombinant) subcutaneous injection for co-administration with Profasi 5000 IU (chorionic gonadotropin) for the induction of spermatogenesis 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 ministry. It is anticipated that the therapy will be launched in the second quarter of 2006, according to a company news release.

"The registration of Gonal-f in Japan is a key milestone in the fulfillment of our vision of providing a biotech version of [follicle-stimulating hormone] on a worldwide basis. We will continue to work with the Japanese authorities to register Gonal-f in female infertility,"Jacques Theurillat, Serono's deputy chief executive officer, said in the release.

"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," he added.

Male hypogonadotrophic hypogonadism is a significant disease of gonadal function, which 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, officials said.

The efficacy of Gonal-f with Profasi 5000 IU 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 also were assessed and submitted to the Japanese authorities, officials said.

Gonal-f is a highly consistent recombinant human follicle-stimulating hormone (r-hFSH) Filled by Mass (FbM), prescribed to supplement or replace naturally occurring follicle-stimulating hormone, an essential hormone to treat infertility.

For males, Gonal-f has been approved in 56 countries worldwide for gonadal dysfunction associated with absence of sperm in the semen or male hypogonadotropic hypogonadism. In all markets where Gonal-f is approved for this indication, the therapy needs to be in combination with hCG, in this case Profasi, officials said.

Gonal-f has been approved in 94 countries worldwide including Europe and the United States with indications of stimulation of the growth of ovarian follicles and ovulation in women. It is the most widely prescribed gonadotropin in the world.

Serono is a Geneva, Switzerland, biotechnology company with a focus on reproductive health, neurology, metabolism and growth. It recently entered new therapeutic areas including psoriasis and oncology.

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