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| |  NTZ Granted Expanded Access for AIDS Patients with Cryptosporidiosis BUFFALO GROVE, Ill., Oct. 15, 1996 -- Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) today announced that the U.S. Food and Drug Administration (FDA) authorized expanded access to the company's nitazoxanide (NTZ) for AIDS patients suffering from Cryptosporidiosis. AIDS Patients Get Expanded Access to NTZ The FDA action allows an expanded open label Compassionate Use study for patients with Cryptosporidial diarrhea. There is no longer a limit on the number of patients who may receive NTZ (previously the limit was 150 patients). The purpose of this study is to provide NTZ to AIDS patients who suffer from Cryptosporidiosis and are unable to participate in controlled clinical trials. The expanded use study also will provide additional safety and efficacy data from a broader patient base and at higher NTZ doses, which will support Unimed's planned Phase II/III placebo-controlled study expected to begin by year end. There is no consistently effective or approved therapy for Cryptosporidiosis, 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 this condition. For them this diarrhea can be chronic, severe and often life-threatening. Previous NTZ Studies Show Positive Results As previously reported, NTZ has shown positive results in treating Cryptosporidial diarrhea. A Phase II clinical trial was recently completed with AIDS patients who had Cryptosporidial diarrhea and failed to respond to other therapies. The results showed that 58 percent had a clinical response, with 50 percent having complete or partial reduction in bowel movement frequency. In addition, interim results of an ongoing Compassionate Use study of NTZ also were positive. NTZ was associated with 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. "A Phase II/III study is planned to begin by year end to more fully demonstrate the safety and effectiveness of NTZ," said Stephen M. Simes, Unimed president and CEO. "NTZ is approved for marketing in Mexico and has been designated an Orphan Drug by the FDA. This compound shows great promise for treating a condition in which therapies are urgently needed. We plan to submit results of the expanded use study and the Phase II/III study to health authorities in the U.S. and other countries, as we seek approval to market NTZ." NTZ is a nitrothiazole benzamine compound with activity against a number of protozoan and helminthic 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 subsidiary of BioChem Pharma (Nasdaq: BCHXF). 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 marketing and late-stage development products.
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