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REALITY FEMALE CONDOM APPROVED BY FDA

 JACKSON, Wis., May 10 /PRNewswire/ -- Wisconsin Pharmacal (NASDAQ: WPCI) received approval to market its Reality female condom from the U.S. Food and Drug Administration (FDA).
 The Reality female condom is a sheath worn by women to provide protection from unintended pregnancy and sexually transmitted diseases (STDs), including AIDS. Reality is the first female condom approved by FDA. It is the first and only product under a woman's control that is approved by FDA to prevent sexually transmitted diseases (STDs), including AIDS, and unintended pregnancy. It is the first of a class of new products approved to help prevent AIDS since the epidemic began more than 10 years ago.
 FDA and Wisconsin Pharmacal finalized the product labeling last week. This was the last step in its development and regulatory approval. The company and FDA agreed on labeling requirements and other conditions of approval. Each product label will contain the following statements:
 -- Latex condoms for men are highly effective at preventing sexually transmitted diseases, including AIDS (HIV infection), if used properly.;
 -- If you are not going to use a male latex condom, you can use Reality to help protect yourself and your partner.
 -- Reality only works when you use it. Use it every time you have sex.
 -- Before you try Reality be sure to read the directions in the box and learn how to use it properly.
 The Reality female condom was tested for use over six months in U.S. women. Based on direction from the FDA Advisory Panel and the need for contraceptives controlled by women which also protect against STDs, the development program was accelerated and was not as long and did not include as many women as other contraceptive studies. The study shows Reality provides protection against pregnancy. The pregnancy rate in the 6-month study was 13 percent. The estimated one-year pregnancy rate for Reality ranges from 21 percent to 26 percent. This rate, which can be as high as one in four women who may become pregnancy during one year, is believed to be the result of improper use. Women who use Reality correctly with every sex act can expect a much lower pregnancy rate.
 All contraceptives are serious products and must be used properly to achieve protection. Very few truly new contraceptives have been approved in the last 10 years. Most are prescription products which protect only against pregnancy. Reality is a new option and will be available to women without a prescription. "This is a serious product dealing with the serious issues of unintended pregnancy and STDs, including AIDS," Leeper said. "Studies show that only about 20 percent of women use male condoms. Reality is another choice for those women who are not going to use a latex male condom. We will begin to ship the device on a priority basis within the next 8-10 weeks to clinics, physicians, and STD outreach centers. We plan to initiate a broad education program to health care professionals working with women at risk to unintended pregnancy and STDs, including AIDS. There are a large number of women concerned about their health who will want to see if the Reality female condom works for them."
 Wisconsin Pharmacal is the licensee of the Reality female condom for the U.S., Canada and Mexico. Chartex International in London is the licensor and the world manufacturer of the product. Wisconsin Pharmacal will now request the FDA to approve the Chartex facility as the major supplier for the U.S. market. Once this occurs, broad commercial distribution will begin. Wisconsin Pharmacal hopes to have national distribution of the Reality female condom by year end. It will be sold for $2.50 at the pharmacy and other outlets where condoms are sold. The Reality female condom will also be available at reduced cost to public sector clinics and agencies.
 "The Reality approval reflects 5-1/2 years of research," stated John Wundrock, president and CEO. "Wisconsin Pharmacal as a small company is pleased to have taken the development risk and proud to be able to make this first-of-its-kind product available to American women."
 THIS TABLE SHOWS THE OVERALL PREGNANCY RATES FROM STUDIES OF BARRIER CONTRACEPTIVES. If the method is USED CORRECTLY with EVERY SEX ACT, the risk of pregnancy WILL BE LOWER. If the method is NOT USED CORRECTLY with every sex act, the risk MAY BE HIGHER. Systemic contractive products not listed here, such as birth control pills, are more effective at preventing pregnancy.
 OVERALL PREGNANCY RATES FOR BARRIER CONTRACEPTIVES
 Condoms which protect against pregnancy and
 sexually transmitted diseases:
 Pregnancy Rates
 Six Months (B) One Year
 Reality Female Condom (A) 13 percent 26 percent
 Male Latex Condom (C) 8 percent 15 percent
 PREGNANCY RATES WITH OTHER METHODS
 Pregnancy Rates
 Six Months (B) One Year
 Cervical Cap 10 percent 18 percent
 Diaphragm 8 percent 15 percent
 Sponge 12 percent 17 percent
 Unprotected Sex (D) 85 percent
 (A) Yearly failure rates for Reality were estimated by doubling the 6-month pregnancy rate.
 (B) Pregnancy rates for Reality, Cervical Cap, Diaphragm and Sponge are from clinical trials. Actual use failure rates may be higher or lower.
 (C) 1988 National Survey of Family Growth.
 (D) Trusell, et al., Studies in Family Planning 21 (1),
 Jan/Feb 1990.
 -0- 5/10/93
 /CONTACT: Dr. Mary Ann Leeper, senior vice president-development 312-280-8541 (Reality product information); John A. Wundrock, president and CEO, 414-677-4121 (company information), both of Wisconsin Pharmacal; or Michele de Milly of Geto & de Milly, 212-686-4551 (press information), for Wisconsin Pharmacal/
 (WPCI)


CO: Wisconsin Pharmacal ST: Wisconsin IN: MTC SU: PDT

SH -- NY026 -- 6384 05/10/93 10:15 EDT
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Date:May 10, 1993
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