Breakthrough on the cusp of launching the first new male contraceptive is emerging from a university startup 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.
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A new birth control method for men has the potential to win as much as half the $10 billion market for female contraceptives worldwide. 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 to 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 is known as reversible inhibition of sperm under guidance, or RISUG and is reversed with a second shot that breaks down the gel, thus allowing sperm to reach the penis normally.
The procedure is 98 percent effective at preventing pregnancy-about the same as condoms if they are used every time-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.
Although an earlier clinical trial involving the administration of hormones via injection and an implant was “efficient, with a tolerable side effect profile,” Kranz said, the Leverkusen, Germany-based drugmaker wasn’t convinced this “inconvenient” regimen would find sufficient market acceptance. Male contraception isn’t an area of active research for Pfizer and Merck either, representatives said. Both companies sell products for female fertility control.
Side effects aside, it would take about $100 million and 10 years to bring a hormone-based male birth control pill to market-a low-priority undertaking for pharmaceutical executives, Coelingh Bennink said.
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“In doing anything abroad, quite substantial money is required, and that can only come from the pharmaceutical industry,” Guha said in his office at the Indian Institute of Technology in Kharagpur, about 80 miles (130 kilometers) west of Kolkata.
By Premji
