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MOLECULAR GENETICS CISPLATIN CHEMOPROTECTIVE COMBO AGENT PHASE II

Executive Summary

MOLECULAR GENETICS CISPLATIN CHEMOPROTECTIVE COMBO AGENT PHASE II trials have been underway since June. According to the Minnetonka, Minnesota-based firm, animal studies on the chemotherapeutic protective agent MGI-136 have shown that it "appears to reduce certain toxic side effects of cisplatin upon the kidneys, bone marrow and, potentially, the nervous system." Because cisplatin's side effect profile limits its therapeutic use, Molecular Genetics hopes that MGI-136 will be eligible for expedited FDA review. Based on cisplatin's wide use, Molecular Genetics predicts that MGI-136 could produce revenues of over $ 50 mil. annually. U.S. cisplatin revenues in 1987 topped $ 70 mil., according to the company. A disinfectant mouthwash (MGI-122) for use in reducing the incidence of mouth ulcers and related oral infections in chemotherapy patients is also in active late stage testing. The mouthwash, which is currently marketable as an OTC oral mucosal injury treatment, is in clinicals at a "major" U.S. medical center for the cancer indication, the firm said. The company's third near-term drug development project is MGI-647, a quality-of-life oral treatment for the alleviation of one of the long-term side effects of therapeutic radiology. The treatment, for which the firm filed an IND in February, is on "clinical hold now," a spokesperson said, but Phase II trials are expected to begin "imminently." The company plans to seek orphan status for the drug, which is an oral form of a long-used topical. Molecular Genetics has hired former Beecham Labs Ethical Drugs Division VP Sales Edward Ruane to fill the newly-created post of VP sales, pharmaceutical division in preparation for launching these oncology products. Ruane, 49, was with Beecham for 17 years in sales. He was the product manager for the 1987 launch of Amoxil (amoxicillin). Ruane also has prior experience with Bristol Labs and Wyeth Labs. Other products in the pipeline are the generic cardiovascular MGI-613. The company earlier this year said it anticipated filing for registration of the drug in 1989 and expected to go to market in 1990. The company also has a Lyme Disease vaccine (MGI-805), which it hopes to license or sell. Further back in the pipeline are an acne vulgaris treatment (MGI-434) and a diabetic retinopathy treatment/preventive (MGI-197). Preclinical animal testing was scheduled to start this year on both compounds. Molecular Genetics plans to focus its initial product launches on physician specialists, enabling it to make use of a small sales force. The publicly-traded firm is led by Chairman and CEO Kenneth Tempero, MD, PhD, a former Searle and Merck clinical R&D exec. The company, which was formed in 1979 as an ag-biotech R&D start-up, discontinued its animal health business in 1987 and completed the restructuring in April with the sale of its plant research business. The sale left Molecular Genetics with a $ 38 mil. cash reserve.
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