Drugmakers step up work towards male pill

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Drugmakers step up work towards " male pill "

Last Updated: 2004-01-21 11:15:29 -0400 (Reuters Health)

By Sitaraman Shankar

FRANKFURT (Reuters) - German drugmaker Schering AG said on Wednesday it

and Dutch firm Organon had started mid-stage trials on a contraceptive

injection for men that could be the next step towards 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 centres 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 towards 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.

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 millilitre

of semen, and concentrations of 300-400 million sperm per millilitre 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 1006 GMT, while

Akzo was 0.32 percent up at 31.61 euros.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org