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| |  NTZ Phase II/III Trial With AIDS Clinical Trials Group BUFFALO GROVE, Ill., Nov. 12, 1996 -- Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) today announced that the AIDS Clinical Trials Group (ACTG), a cooperative supported by the National Institute of Allergy and Infectious Diseases, will conduct a Phase II/III placebo controlled study of nitazoxanide (NTZ) to treat AIDS patients with cryptosporidiosis. The HIV Disease Research Agenda Committee of the adult ACTG has approved the trial, which is designated protocol 336. As the largest HIV clinical organization in the world, the ACTG plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the United States and the developed world. No Currently Approved Treatment for Cryptosporidiosis The ACTG study has been designed to better understand the activity and potential of NTZ as a single agent in treating cryptosporidiosis. There currently is no consistently effective or approved therapy for this condition, caused by a microscopic protozoan parasite. Symptoms include profuse diarrhea, abdominal cramping, urgency, severe dehydration and weight loss. It is estimated that 15-20 percent of AIDS patients suffer from cryptosporidiosis. For them this diarrhea can be chronic, severe and often life-threatening. Trial to Test NTZ The ACTG Phase II/III clinical trial is expected to start by the end of 1996. This is a six week double blind, placebo-controlled trial designed to determine the efficacy and safety of NTZ in AIDS patients with cryptosporidiosis. After the six weeks, all patients will be randomized to active therapy at two different doses for six months. This will determine potential relapse rates in people taking one of two different doses to continue suppressing cryptosporidiosis. The study is expected to enroll approximately 60 HIV positive individuals with cryptosporidiosis. Twenty patients will be started on placebo and switched to active therapy after a three-week placebo period. The study provides for patients not responding adequately in the initial active group to be switched to a higher dose treatment group. The clinical trial will be funded by the ACTG, with Unimed providing the active NTZ tablets as well as placebos. Unimed also will provide supplemental funding. The results of the ACTG Phase II/III study will be submitted by Unimed to the FDA. NTZ Shown Effective In Previous Studies A Phase II trial of NTZ was recently completed. It showed that 58 percent of the patients, with both AIDS and cryptosporidial diarrhea and who had failed on other therapies, had a clinical response. Fifty percent had complete or partial reduction of bowel movement frequency. Interim results of an ongoing Compassionate Use study showed a significant progressive decrease in the frequency of bowel movements and liquid stools by the end of the first week. Moreover, body weight in these patients increased by approximately one pound per week during eight weeks of therapy. "We are pleased that after an extensive review of NTZ, the ACTG chose to study it in treating cryptosporidial diarrhea," said Stephen M. Simes, Unimed president and CEO. "NTZ is approved for marketing in Mexico and has been designated an Orphan Drug by the U.S. Food and Drug Administration. NTZ shows great promise for treating a condition where therapies are urgently needed. We plan to submit results of the ACTG Phase II/III study and an ongoing open label Compassionate Use study to health authorities in the U.S. and other countries, as we seek approval to market NTZ." NTZ is a nitrothiazole benzamide compound with activity against a number of protozoan and helmithic pathogens. Unimed holds an exclusive license to develop and market oral dosage formulations of NTZ for human use in the U.S., Canada, Australia and New Zealand from Romark Laboratories, L.C. in Tampa, Florida. NTZ has been sublicensed, for the Canadian marketplace only, to BioChem Therapeutic, Inc. the wholly owned therapeutic subsidiary of BioChem Pharma (Nasdaq: BCHXF). Statements made in this release that present information that is not historic, including among other things, anticipated financial performance, business prospects, new products and markets, and research and development activities, are forward-looking statements. The risks that may affect operations, development and results include clinical outcomes in drug development programs, regulatory matters, proprietary rights challenges, market acceptance, competition, and other matters discussed in the Company's Form 1O-K and other periodic reports. Unimed Pharmaceuticals develops and markets niche pharmaceutical products for AIDS, endocrinology, urology and other therapeutic areas. The company also is growing through in-licensing niche marketed and late-stage development products.
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