WASHINGTON Female Health Co has won U.S. approval to market its newer, less expensive female condom, which could help it win over American women as well as boost use in developing countries, the company said on Wednesday.
The company's FC2 Female Condom is made with a softer material for quieter use. Its original version failed to gain a foothold in the male condom-dominated U.S. marketplace in part because it was noisy to use, as well as more expensive.
Its new condom is made using a less costly process that company officials have said should lower its shelf price, as well as allow health organizations to distribute more of the birth control device to women in Africa and other areas where AIDS is a major concern.
The approval "is an important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world," Female Health Co's strategic adviser Mary Ann Leeper said in a statement.
The Chicago-based company's shares rose as much as 30 percent after the news. Its shares closed up 22 percent, or 68 cents, at $3.73 on the American Stock Exchange on Wednesday.
Female Health's initial Female Condom was approved in 1993 to prevent pregnancy, as well as sexually transmitted diseases (STDs), but has not been widely used in the United States, which made up just 10 percent of its 34.7 million unit sales in 2008.
The product competes with other birth control methods, most notably male condoms, which can cost as little as 50 cents each amid a variety of competing brands. The original Female Condom costs between $2.80 and $4 apiece.
While it is not clear what the retail price will be for FC2, Leeper told Reuters it will cost as little as 60 cents when sold directly to health organizations and government agencies. That will help more groups offer more condoms in the hope of preventing HIV/AIDS and other STDs, she added.
"Having a less expensive Female Condom increases the probability of women who need it having access to it," she said.
Despite the FDA's approval it could be next year or longer before U.S. consumers can buy the new condom in stores.
Female Health is still looking for a pharmaceutical or device company to help it market and distribute FC2, including possibly a male condom maker, Leeper said.
"We're just gearing up," she said. "Our wish is to find a partner who has the capacity to do a good job in getting the message out to the consumer and who has the commitment to women's health."
In the meantime, the original version will be available until inventory is sold and the FC2 will be available to U.S. women through local health agencies and groups such as Planned Parenthood, Leeper said.
Diana Zuckerman, head of the National Research Center for Women & Families, said the FC2 is unlikely to be a big seller in the United States but could win over more users elsewhere.
"I am not assuming that the Female Condom is going to be hugely popular in this country because there are so many other alternatives. I think it's going to be extremely popular in other countries where there are not affordable options," she said.
The FDA's approval allows the United States Agency for International Development and other U.S. organizations to buy the FC2 Female Condom and distribute it to global programs that try to prevent the spread of the virus that causes AIDS, the company said.
Dozens of health advocacy groups had urged U.S. approval of the new version, which the company said is already distributed in 77 other countries.
Only condoms have been proven effective at preventing STDs, but "not everybody wants to use male condoms," said Serra Sippel, executive director for the Center for Health and Gender Equity.
"(Male) condoms have been stigmatized in a lot of areas," she said, adding that female versions give "women another option in negotiating safer sex with their partners or husbands."
(Reporting by Susan Heavey; Editing by Bernard Orr, Andre Grenon, Richard Chang)