Female Health Company

A Female Condom Timeline

The Female Condom is a remarkable example of the results of steady private-public collaboration. It took two decades of patient development for the company to become profitable.

Since the mid-1980s, private investors have put up more than $140 million to develop, secure regulatory approvals and launch the Female Condom. Annual losses for FHC and predecessor company Wisconsin Pharmacal Company (WPC) occurred for the first 18 years, from 1988 to 2005.

Global public sector agencies, country governments and public and private donors have been instrumental in helping the Female Condom gain greater acceptance. Female Condoms are now available in 100 countries worldwide.

Surmounting multiple barriers

The need for HIV/AIDS prevention is obvious, yet FHC encountered a number of barriers in developing the market:

· Initial lack of support from a number of public and private groups who were skeptical the product would be used by women.

· Social mores in many countries reflected the belief that distribution of condoms would encourage sexual promiscuity and abstinence should be emphasized.

· Lack of funding for HIV/AIDS prevention.

· As a first-of-its-kind product, people needed to be educated how and why to use the Female Condom.

· Comparatively high production costs vs. male condoms, which benefit from economies of scale.

FHC has addressed all of these challenges since the 1990s, making steady progress in greater support for and acceptance of Female Condoms. Multiple clinical studies consistently demonstrated that, when the Female Condom was made available as an option there is a higher percentage of protected sex acts and a decrease in sexually transmitted infections.

Important milestones in the development of the Female Condom:

1980s     A Danish physician invents the Female Condom and sells the rights to Chartex Resources Limited, a private British company. In the early years, Chartex was financially supported by a Danish entrepreneur and a Danish foundation.

1993       WPC secures Food and Drug Administration (FDA) approval for the Female Condom.

1994       Chartex secures FDA approval for its U.K.-based manufacturing facility to export Female Condoms to the United States.

1996       The WPC entity legally changes its name to The Female Health Company, a U.S. public company. FHC purchases Chartex and now owns worldwide rights to the Female Condom, and begins to build partnerships and alliances with global public health agencies and governments.

2003       To promote proper use and educate women worldwide, FHC establishes the Global Public Sector (GPS) team. This development is critical to develop a global market for the Female Condom.

2003       FC1 unit sales reach 13.4 million; FHC begins development of FC2.

2005       FHC submits a scientific dossier for FC2 to the World Health Organization (WHO) and secures European Union approval for FC2.

2006       FC2 receives clearance from WHO for bulk purchases of FC2 by United Nations agencies. This is also the year India and Brazil regulatory agencies approve FC2, and FHC experiences its first profitable year.

2007       Distribution of FC2 begins in countries outside of the United States.

2008       The U.S. FDAs OB-GYN Advisory Committee unanimously recommends to the FDA that FC2 be approved.

2008       Combined unit sales for FC1 and FC2 top 34 million.

2009       FC2 approved by the U.S. Food and Drug Administration.

2009       FHCO listed on the NASDAQ-CM stock exchange.