Big pharma not interested in 'male pill'


22 June 2007

Ned Stafford/Hamburg, Germany

German drug giant Bayer has officially stopped research and development of a hormonal male contraceptive, yet another sign that the pharma industry has lost interest in developing the so-called 'male pill.'

Bayer had previously indicated it would stop the programme, but company officials confirmed the decision this week at a meeting in Leverkusen, Germany. The male contraceptive research had been carried out as a joint project between German pharma firm Schering and US-based Organon. However, Bayer last year acquired Schering for Euro17 billion (11 billion) and the cooperation with Organon was ended.

Berlin-based Bayer Schering Pharma spokeswoman Denise Rennmann told Chemistry World that three factors contributed to the decision. First, there were lingering questions whether the method, which included an implant delivering a synthetic form of progesterone, together with quarterly injections of testosterone, was 'medically technically feasible.' Although the method was successful in Phase II trials with about 300 participants in six European nations, a much larger group of men would need to be tested in Phase III trials for regulatory approval, Rennmann said.

"It is not as convenient as a woman taking a pill once a day"
- Denise Rennmann, Bayer Schering Pharma

Second, the implant needed changing once a year and, along with injections every three months, Bayer felt market demand for such a complicated process would be limited. 'It is not as convenient as a woman taking a pill once a day,' she said.

Third, the method did not fit with Bayer's business strategy following the acquisition of Schering, with the company's drug discovery research focusing on oncology, cardiology, women's healthcare and diagnostic imaging. Rennmann says the firm has no other hormonal male contraceptive method in development, but noted that ideas could come up during the course of women's healthcare research.

Organon, a unit of Dutch firm Akzo Nobel, also closed down its hormonal male contraceptive program, according to spokeswoman Monique Mols, based in Oss, the Netherlands. 'Despite 20 years of research, the development of a [hormonal] method acceptable to a wide population of men is unlikely,' she told Chemistry World. Organon will now focus entirely on non-hormonal male contraceptives, she said, adding that the firm is still in a 'very early research stage' in this area.

Elaine Lissner, director of the Male Contraception Information Project (MCIP) in San Francisco, conceded that Bayer's rationale for stopping the 'male pill' makes sense.

"Treating healthy young people is a risky business to be in"
- Elaine Lissner, Male Contraception Information Project

'Bayer is in business to make money, and they didn't think they could sell a lot of it in this form,' Lissner told Chemistry World, adding that they are not alone. Big pharma companies are dropping out of male contraceptive research, she said.

'Treating healthy young people is a risky business to be in,' she explained. Big pharma firms is reluctant to open up new areas of liability, preferring instead to play it safe by developing new regimens of the pill for women.

'We shouldn't expect companies to put public interest over the interest of their stockholders,' said Lissner.   'If we want something truly new, we should make sure government and foundations fully fund contraceptive research.'

Chemistry has a major role to play in the development of male contraceptives, she said. For example, a compound called RISUG (Reversible Inhibition of Sperm Under Guidance), currently showing the 'most promise' as a male contraceptive, is based on polymer chemistry. The Indian firm Marksans Pharma has a contract with the Indian government to produce the latest batch of RISUG polymer for use in a recently-started clinical trial, said Lissner.

 

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