FDA Approves New, Less Expensive Female Condom

Female condom (FC1)

While standard condoms are an effective way to prevent sexual transmission of HIV, researchers, advocates, and at-risk women have sought a prevention method that can be controlled by women.

The original female condom (FC1) distributed by the Female Health Company (FHC) under the brand name Reality offered a potential solution, but at $3 to $4 per unit, it was too costly for widespread distribution in resource-limited settings.

Last week, FHC announced that the U.S. Food and Drug Administration has approved a new second-generation female condom, dubbed FC2. The new product has the same design -- a pouch inserted into the vagina -- but it is made from nitrile rather than plastic.

Despite its name, the internal condom potentially could also be used by either women or men for anal sex, although it has not been specifically tested for this purpose.

Since the new product is less expensive to produce, it should be made available at a lower cost (though the price has not yet been set). Advocates have called on the U.S. government to include distribution of the FC2 female condom as part of the President's Emergency Plan for AIDS Relief (PEPFAR) program.

Below is an edited excerpt from a recent FHC press release providing more information about the new female condom. The following day, the company issued a second release stating that it plans to install 6 additional production lines to produce the FC2 female condom in Malaysia, thereby increasing manufacturing capacity by 150%, from 30 million to approximately 75-80 million units.

Female Health Company Receives FDA Approval for FC2 Female Condom

Lower Cost Female Condom Increases Access to Woman-Initiated Protection against HIV/AIDS

Chicago, IL -- March 11, 2009 -- The Female Health Company (NYSE Alternext: FHC) today announced approval from the U.S. Food and Drug Administration (FDA) for the company's FC2 Female Condom (FC2), a woman-initiated barrier method that helps to protect against sexually transmitted infections (STIs), HIV/AIDS, and unintended pregnancy. FHC's lower-cost second generation female condom will now be available for purchase and distribution in the United States. FDA approval will also enable the United States Agency for International Development (USAID) to procure FC2 for distribution to global HIV/AIDS programs.

The FDA's approval states that the FC2 Female Condom is indicated for preventing pregnancy, HIV/AIDS, and other sexually transmitted infections (STIs).

FC2: Addressing an Unmet Need for Woman-Initiated HIV Prevention

The data on changing patterns in the incidence and prevalence of HIV/AIDS and other STIs and the rates of unintended pregnancy suggest that there is an unmet need for women-initiated prevention methods. Unintended pregnancy and HIV infection are significant public health challenges in the U.S. The most recent data from the Centers for Disease Control and Prevention (CDC) indicate that one-half of U.S. pregnancies are unintended, and one in four young people aged 15 - 20 contracts an STI each year. The proportion of women among people living with HIV/AIDS (PLHIV) in the U.S. has also tripled over the past two decades --from 8 percent of PLHIV in 1985 to 26 percent in 2007. High-risk heterosexual contact is responsible for 80 percent of new HIV infections among American women.

HIV/AIDS is more prevalent among African American and Hispanic women. According to the CDC, the AIDS case rate in 2004 was 23 times higher among African American women and five times higher among Hispanic women than among Caucasian women.

"Nearly three decades after the start of the global AIDS pandemic, FHC's female condoms remain the only safe and effective woman-initiated HIV prevention method approved by the FDA," said Dr. Mary Ann Leeper, FHC's senior strategic advisor. "Today's approval of FC2 -- a lower-cost, second-generation female condom -- is an important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world."

FHC's first-generation FC Female Condom (FC1) originally received FDA approval for distribution in the United States in 1993. FC1 is also included in the World Health Organization's (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 female condoms have been distributed in 142 countries.

Introduction of a More Cost-Effective Manufacturing Process

The cost of FC1 has remained a key barrier to increased uptake by HIV prevention programs in the U.S. and globally. While numerous studies over the past two decades have indicated that acceptability of FC1 is comparable to the male condom among both male and female users, the high cost of FC1 has limited procurement by government programs and direct purchase by individual consumers.

This cost factor has reduced public access to the only safe and effective woman-initiated method of HIV and STI prevention developed since the start of the global AIDS pandemic. It is estimated that the annual global public sector male condom market is approximately 10 billion units versus about 35 million Female Condoms distributed in FY 2008. This suggests a remarkable opportunity for the Female Condom to strengthen access to HIV/AIDS prevention tools through increased access to the only woman-initiated prevention method.

As a result, five years ago FHC initiated the development of the FC2 Female Condom to expand access to women at risk of HIV and STIs by significantly lowering the cost of the product. FHC has succeeded in reducing FC2's cost through the introduction of a new material and a different manufacturing process. FC1 is made from polyurethane and involves a labor-intensive manufacturing process, while FC2, which looks very similar to FC1, is made from a proprietary nitrile polymer that allows it to be manufactured using a highly automated process. Studies have shown that FC2 performs in a comparable manner to FC1.

As a result of FHC's development program, FC2 will be available to the public sector at a cost as much as 30 percent less than FC1, contingent on volumes of procurement. In addition, the company has indicated that as public sector volume increases, additional cost reductions may be possible.

"Research has shown that the Female Condom can strengthen HIV prevention by providing men and women with access to more prevention options," said Dr. Leeper. "In studies where the FC Female Condom is distributed by prevention programs together with the male condom, the rate of unsafe sex acts decreased and the rate of new STI infections declined significantly as compared to when only male condoms were available. FC Female Condoms put the power of protection in women's hands."

Data on FC2 have been reviewed and approved by other regulatory agencies, including the European Union, WHO, and agencies in India and Brazil. In 2006, the World Health Organization (WHO), based on its own review of the scientific data, agreed that FC2 performs in the same manner as FC1 and cleared FC2 for purchase by UN agencies. Since then, over 23 million FC2 Female Condoms have been distributed in 77 countries. FDA approval of FC2 will allow USAID to procure the second-generation female condom at a lower unit cost for U.S.-funded prevention programs around the world.

Performance of FC2 Female Condom in Clinical Trial

FHC presented data from a randomized, double-blind, crossover, comparative trial of FC2 with FC1. The clinical trial was conducted in 2004 by the Reproductive Health and HIV Research Unit of the University of Witwatersrand in South Africa. Over 200 women participated in the study. The results of the study showed that FC2 is safe and that the risk of FC2 failure modes during use was comparable to FC1. Results from the study were originally published in the journal Contraception. (See Contraception 73 (2006) 386-393.)

About The Female Health Company

The Female Health Company, headquartered in Chicago, IL, manufactures and markets the FC Female Condom (FC1) and the FC2 Female Condom (FC2), which are primarily distributed by public health organizations and donor groups in over 90 developing countries around the world. Globally, the Female Condoms are available in various programs in 116 countries. The company owns certain worldwide rights to FC1, including patents that have been issued in the United States, United Kingdom, Japan, France, Italy, Germany, Spain, the European Patent Convention, the People's Republic of China, Canada, South Korea and Australia. FC1 and FC2 are the only available FDA-approved products controlled by a woman that offer dual protection against sexually transmitted diseases, including HIV/AIDS, and unintended pregnancy.

For more information about the Female Health Company, visit the Company's website at http://www.femalehealth.com and http://www.femalecondom.org.

3/17/09

Sources

Female Health Company. Female Health Company Receives FDA Approval for FC2 Female Condom. Press release. March 11, 2009.

Female Health Company. The Female Health Company to Expand Manufacturing Capacity for FC2 Female Condom by 150%. Press release. March 12, 2009.