The Female Health Company Reports:
FEMALE CONDOM APPROVED IN JAPAN
Taiho Pharmaceutical Co., Ltd., will introduce the
female condom to Japanese women
CHICAGO (November 11, 1999) –
The Female Health Company (OTC BB: FHCO) announced today that Japan’s regulatory body, Koseisho, has approved the female condom for marketing and distribution in Japan.This is significant news for Japanese women because oral contraceptives have only recently been approved in Japan. Thus barrier methods, specifically male condom use, are the main method of contraception. About 85 percent of couples seeking protection use male condoms. The market for male condoms in Japan is about 600 million units; the majority of these condoms are purchased by women.
The Koseisho approval is the result of a successful four-year development program involving a major clinical trial conducted at 10 centers by Taiho Pharmaceutical, the Female Health Company’s partner in Japan. The study results indicate that when used consistently and correctly, the female condom is more than 97 percent effective in preventing pregnancy. As reference, the results in the U.S. showed the female condom was 95 percent effective when used consistently and correctly.
"Positive results from our clinical trials showed that the female condom has a very favorable relative overall acceptability rating of 89 percent, so we are looking forward to a successful launch of this product in Japan," said Tatsuo Watanabe, Director, Public Affairs, of Taiho Pharmaceutical. "We will now be able to provide women in Japan with another option when it comes to protecting themselves and their overall health."
Taiho Pharmaceutical will be responsible for marketing and distributing the female condom in Japan. Subsequent to completing post approval inventory and distribution programs to insure broad availability through the country, Taiho anticipates launching the product during the first six months of 2000 under the name Myfemy. A major integrated marketing campaign is planned for the launch and will include advertising, sales promotion and public affairs.
"The approval in Japan is exciting news for women in Japan and is a major step in the global commercialization of the female condom," said Mary Ann Leeper, Ph.D., president of The Female Health Company. "Having the female condom as a choice empowers women all over the world by giving them an opportunity to
take control of their own health."Taiho Pharmaceutical is a major pharmaceutical company with more than 600 sales representatives and distribution in 40,000 drug stores in Japan. It is dedicated to the research, development, and marketing of pharmaceuticals and medical device products.
The Female Health Company, based in Chicago, Ill. owns certain worldwide rights to the female condom including patents which have been issued in the United States, United Kingdom, Japan, France, Italy, Germany, Spain, the People’s Republic of China, Canada, New Zealand, South Korea and Australia. The female condom is the only product controlled by women that helps to prevent STDs including HIV/AIDS and unintended pregnancy. The female condom is made of polyurethane, which is strong and unlikely to rip or tear during use or cause allergic reactions. It is manufactured in a state of the art facility in London, England.
"Safe Harbor" Statement under the Private Securities Litigation Reform Action of 1995: The statements in this release which are not historical fact are forward-looking statements 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, including such things as product demand and market acceptance; the economic and business environment and the impact of governmental regulations, both in the United States and abroad; the effects of competitive products and pricing pressures; currency risks; capacity;
efficiency and supply constraints; and other risks detailed in the Company’s press releases, shareholder communication and Securities and Exchange Commission filings.
Actual events affecting the Company and the impact of such events on the Company’s operations may vary from those currently anticipated.
For more information about The Female Health Company toll-free via fax,
dial 1-800-PRO-INFO and enter company code "FHCO."
Also, visit the Company's web site, www.femalehealth.com.
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Contacts: Investors Product Media
William R. Gargiulo, Jr. Mary Ann Leeper,Ph.D. Desta Davis
231.526.1244 312.280.1119 312.397.6070
If you have any questions or comments, please send them to us info@femalehealth.com