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| |  Expanded Orphan Drug Designation for NTZ BUFFALO GROVE, Ill., Jan. 21, 1997 -- Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) today announced the Food and Drug Administration (FDA) has expanded the Orphan Drug designation for nitazoxanide (NTZ) to all immune-compromised patients with Cryptosporidiosis. (The prior designation was limited to treating Cryptosporidiosis in HIV positive and AIDS patients). Orphan Drug designation is reserved for conditions that affect fewer than 200,000 patients. If NTZ is approved for the treatment of Cryptosporidiosis in HIV positive and AIDS patients or other immune-compromised patients, Unimed will receive seven years of marketing exclusivity and certain tax credits. As previously announced, NTZ will begin its last phase of clinical trials immediately. The trial will be conducted and funded by the AIDS Clinical Trials Group (ACTG), a cooperative supported by the National Institute of Allergy and Infectious Diseases. 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. Other patients who can suffer the devastating symptoms of Cryptosporidiosis include the elderly, cancer patients, and transplant patients, all of whom may be immune-compromised. NTZ Shown Effective in Previous Studies A Phase II trial of NTZ has been completed. It showed that 58 percent of the patients, with both AIDS and cryptosporidial diarrhea and who failed to improve on other therapies, had a clinical response. Fifty percent had complete or partial reduction of bowel movement frequency. Interim results from Unimed's ongoing open-label studies show 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 delighted with the new expanded Orphan Drug designation for NTZ," said Dr. Robert Dudley, Unimed president and CEO. "We are also very pleased that after an extensive review of NTZ, the ACTG chose to study it in treating cryptosporidial diarrhea. NTZ shows great promise for treating a condition where therapies are urgently needed. We plan to submit results of the ACTG study and the ongoing open-label NTZ trial to health authorities in the U.S. and other countries, as we seek approval to market NTZ." NTZ is a nitrothiazole benzamide compound that can combat 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. This release includes forward-looking statements: information that is not historic, including among other things, anticipated financial performance, business prospects, new products and markets, and research and development activities. Some risks that may affect operations, development and results include clinical outcomes in drug development programs, regulatory matters, proprietary rights challenges, market acceptance, competition. These and other matters are discussed in the company's Form 10-K and other periodic reports.
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