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WISCONSIN PHARMACAL RECEIVES FDA 'APPROVABLE LETTER' FOR REALITY, THE FIRST FEMALE CONDOM

 JACKSON, Wis., April 27 /PRNewswire/ -- Wisconsin Pharmacal Company, Inc. (NASDAQ: WPCI) today received an "Approvable Letter" from the U.S. Food and Drug Administration (FDA) for the company's REALITY(R) female condom. This letter signals the FDA's intention to grant the product final marketing approval in the near future. When launched, REALITY will be the first of a new class of products approved by the FDA to help prevent the spread of AIDS since the epidemic began more than 10 years ago. It will be the only product under a woman's control that helps to prevent sexually transmitted diseases (STDs), including AIDS, as well as unintended pregnancy.
 Women are the fastest growing group contracting AIDS today. By the year 2000, it is estimated that more women than men will be newly infected with HIV through heterosexual intercourse. In addition, approximately 56 percent of all pregnancies in the U.S. are unintended pregnancies of which approximately 66 percent occur in young women.
 "We have worked hard with FDA to complete the necessary documentation," said Mary Ann Leeper, Ph.D., the company's senior vice president, development. "Discussions are ongoing to finalize the product labeling. Recently public health agencies have initiated a new campaign to increase awareness that latex male condoms are effective at preventing STDs, including AIDS. Once approved, women will be able to use the REALITY female condom. This is important when the male condom is not an option."
 The "Approvable" status is based on the preclinical and clinical studies completed to date. While REALITY has not been tested as extensively as other barrier contraceptives, the studies, involving over 1,700 women and 30,000 uses of the device, demonstrate that REALITY prevents pregnancy and reduces the risk of STDs, including AIDS.
 The "Approvable Letter" includes certain post-marketing conditions of approval. Once expected production levels occur at the Wisconsin Pharmacal facility, the company will (1) conduct long term shelf-life studies and, (2) repeat the barrier permeability study. In addition, Wisconsin Pharmacal is required to conduct focus group studies on the final labeling and participate in a large-scale, federally funded clinical study.
 John Wundrock, president and chief executive officer, indicated he is pleased with receipt of an "Approvable Letter" and FDA's expedited review of the REALITY Pre-market Approval Application.
 REALITY is currently marketed as femidom(R) by Chartex International or its partners in the United Kingdom, Switzerland, Austria, Portugal, The Netherlands, and Norway.
 -0- 4/27/93
 /CONTACT: Dr. Mary Ann Leeper, senior vice president-research and development, 312-280-8541 (REALITY Product Information); or John A. Wundrock. president and CEO, 414-677-4121 (Company Information), both of at Wisconsin Pharmacal/
 (WPCI)


CO: Wisconsin Pharmacal Company, Inc. ST: Wisconsin IN: MTC SU:

SM -- NY051 -- 1236 04/27/93 10:20 EDT
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Publication:PR Newswire
Date:Apr 27, 1993
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