Female Health Company Receives FDA Approval for FC2 Female Condom(R) Created by News on 3/11/2009 9:30:50 AM
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(R) (FC2), a woman-initiated barrier method that helps to protect against sexually transmitted infections (STIs), HIV/AIDS, and unintended pregnancy.
Lower Cost Female Condom Increases Access to Woman-Initiated Protection Against HIV/AIDS
CHICAGO, March 11 /PRNewswire/ -- 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(R) (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 White 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(R) (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.)
Special Investor Conference Call
FHC will host an investor conference call Thursday, March 12, 2009, at 11:00 a.m. Eastern Time to discuss the FDA's approval of the FC2 Female Condom(R). Shareholders and other interested parties may participate in the conference call by dialing 800-860-2442 (international participants dial 412-858-4600) and asking to be connected to "The Female Health Company Conference Call" a few minutes before 11:00 a.m. EDT on March 12, 2009. A replay of the call will be available one hour after the call through 5:00 p.m. EDT on March 19, 2009 by dialing 877-344-7529 (international callers dial 412-317-0088) and entering the conference ID 428912.
About The Female Health Company
The Female Health Company, headquartered in Chicago, IL, manufactures and markets the FC Female Condom(R) (FC1) and the FC2 Female Condom(R) (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. If you would like to be added to the Company's e-mail alert list, please send an email to FHCInvestor@femalehealthcompany.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
The statements in this release which are not historical fact are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include expectations regarding the cost of and demand for FC2. These statements are based upon the Company's current plans and strategies, and reflect the Company's current assessment of the risks and uncertainties related to its business, and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events, developments or circumstances. Such forward-looking statements are inherently subject to known and unknown risks and uncertainties. The Company's actual results and future developments could differ materially from the results or developments expressed in, or implied by, these forward-looking statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: product demand and market acceptance; competition in the Company's markets and the risk of new competitors and new competitive product introductions; the Company's reliance on its international partners in the consumer sector and on the level of spending on the female condom by country governments, global donors and other public health organizations in the global public sector; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company's production capacity; efficiency and supply constraints; and other risks detailed in the Company's press releases, shareholder communication and Securities and Exchange Commission filings, including the Company's Form 10-K for the fiscal year ended September 30, 2008. Actual events affecting the Company and the impact of such events on the Company's operations may vary from those currently anticipated.
William R. Gargiulo, Jr.
Mary Ann Leeper
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