Male contraceptive in the works in India, but doesn't look likely to end up on U.S. market

Doctors are on the cusp of launching the first new male contraceptive in more than a century. But rather than a Big Pharma lab, the breakthrough is emerging from a university start-up in the heart of rural India.

Years of human trials on the injectable, sperm-zapping product are coming to an end, and researchers are preparing to submit it for regulatory approval. Results so far show it's safe, effective and easy to use-but gaining little traction with drugmakers. That's frustrating its inventor, who says his technique could play a crucial role in condom-averse populations.

A new birth control method for men has the potential to win as much as half the $10 billion market for female contraceptives worldwide and cut into the $3.2 billion of annual condom sales, according to estimates from the last major drug company to explore the area. India's reversible procedure could cost as little as $10 in poor countries, and may provide males with yearslong fertility control, overcoming compliance problems and avoiding ongoing costs associated with condoms and the female birth control pill.

It could also ease the burden on the 225 million women in developing countries, who the World Health Organization says have an unmet need for contraception. Yet so far only a U.S. nonprofit has taken up development of the technology abroad.

For Sujoy Guha, 76, the biomedical engineer who invented the product, the challenge is to find a company that wants to sell it. But male contraception is an area Big Pharma has so far shown little interest in.

"The fact that the big companies are run by white, middle-aged males who have the same feeling — that they would never do it — plays a major role," said Herjan Coelingh Bennink, a gynecology professor who helped develop the contraceptives Implanon and Cerazette as head of research and development in women's health for Organon International from 1987 to 2000. "If those companies were run by women, it would be totally different."

Guha's technique for impairing male fertility relies on a polymer gel that's injected into the sperm-carrying tubes in the scrotum. The gel, which has the consistency of melted chocolate, carries a positive charge that acts as a buffer on negatively charged sperm, damaging their heads and tails and rendering them infertile.

The treatment, known as reversible inhibition of sperm under guidance, or RISUG, is reversed with a second shot that breaks down the gel, allowing sperm to reach the penis normally.

The procedure is 98 percent effective at preventing pregnancy — about the same as condoms — and has no major side effects, according to R.S. Sharma, head of reproductive biology and maternal health at the Indian Council of Medical Research. About 540 men have received it in India, where it continues to prevent pregnancies in their partners 13 years after treatment, he said.

Kinkar Ari, 39, said that when he and his wife decided they didn't want more children they had a choice between tubal ligation for her or vasectomy for him, but neither could afford the time off to recuperate from the surgery.

When a public health worker told the couple about Guha's promising alternative, Ari decided to enroll in the study. The injection took 15 minutes with local anesthesia, and after half an hour of observation at the clinic, he said, he was able to walk the mile and a half home. Two days later, he was back at work. Ari was so enthused by the procedure he convinced two other couples to have it done, he said.

Such stories encourage Guha to persist, he said, even though patents on his invention have long since expired and he won't see any personal financial gain even if it takes off worldwide.

"Why should the burden be borne by the female only?" he said in his office. "There has to be an equal partnership."