"Male pill" testing starts

[Steeltrap]

Drugmakers Step Up Work Toward 'Male Pill'
Wed Jan 21, 6:16 AM ET Add Health - Reuters to My Yahoo!

By Sitaraman Shankar

FRANKFURT (Reuters) - German drugmaker Schering AG said Wednesday it and Dutch firm Organon had started mid-stage trials on a contraceptive injection for men that could be the next step toward the elusive "male pill."

Schering said trials of the drug, which is a combination of an implant and an injection, would be conducted on 350 men at 14 centers across Europe, and would be completed by December 2005.

Analysts said Schering and Organon, the drugs unit of Akzo Nobel, needed to counter global attitudes toward contraception, still seen largely as the responsibility of women.

A spokesman for Berlin-headquartered Schering, the world's top producer of hormone drugs by volume, said it was too early to estimate peak sales for the drug, but that first results of the trial should be available in early 2006.

The spokesman said it could be on the market in five to seven years.

Analysts said the drug was interesting, but it was too early to include it in their revenue models.

"This is an interesting development from the scientific point of view. From a commercial standpoint, the market still needs to be developed," said Bankgesellschaft Berlin analyst Meng Si.

"It remains to be seen how long it takes for market acceptance, as the traditional view has been that women are responsible for contraception," she said.

MALE PILL STILL ELUSIVE

Guenter Stock, Schering's board member responsible for research, said in a statement that the joint study represented the next big step forward in the development of the first hormonal fertility control for men, which had the potential to be sold worldwide.

Schering and Organon signed a collaboration to develop a male contraceptive in late 2002, and believe they are ahead of rivals. Australian researchers said in October they had successfully suppressed sperm production in a study of 55 couples using two hormones.

Most efforts to make a male pill target testosterone, a hormone made in the testes that stimulates sperm production. But suppressing the amount of testosterone in the body leads to a loss of libido, mood swings and loss of muscle strength.

So any contraceptive that shuts down testosterone production has to be accompanied by a method of retaining adequate levels in the bloodstream.

Schering said that in its trials, the progestogen etonogestrel reduced sperm concentrations, while long-acting testosterone undecanoate maintained testosterone levels within the normal range.

Etonogestrel, a hormone developed by Organon, will be given to patients in implant form, and long-acting testosterone undecanoate, developed by Schering, would be injected into them.

Testosterone injections would be given every 10 or 12 weeks, the spokesman said.

The male pill has been a difficult proposition because progestins and testosterone are not effective in pill form, and so have to be given as a patch, implant or injection.

Developing an effective male pill has also proved elusive in the past because fertile men have more than 20 million sperm in every milliliter of semen, and concentrations of 300-400 million sperm per milliliter are not uncommon.

Surveys in the past have indicated that men, given the choice, would rather not take hormonal contraceptives.

Schering shares were up 0.88 percent at 43.47 euros at 5:06 a.m. EST, while Akzo was 0.32 percent up at 31.61 euros.