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Executive Summary

MGI PHARMA DECISION ON FUTURE OF MGI 136 SET FOR END OF MARCH, the Minneapolis-based cancer products firm said Feb. 10 after Phase III clinical trials of the chemoprotective agent (diethyldithiocarbamate) were suspended "until further notice." The trials were put on hold when an independent safety monitoring committee unblinded the study on Feb. 8 and found that patients receiving MGI 136 were withdrawing in greater numbers compared to the placebo group. Data from the unblinded trials "indicate that patients receiving MGI 136 have a decreased tolerance for therapy," MGI Pharma said. The trials included 200 patients with ovarian and lung cancer treated with cisplatin plus MGI 136 or cisplatin alone. A trend toward increased weight loss also occurred in MGI 136 treated patients, the company said. Analysis of the data will take from two to four weeks, MGI Pharma said. By the end of March, the company anticipates making a decision whether to amend the studies or drop them altogether. If the MGI 136 program suffers "prolonged delay or termination," the firm may exercise several development options, MGI said in a Feb. 13 sales and earnings report. Those options include "development of Didronel I.V. Infusion for the treatment and prevention of osteoporosis in patients on total parenteral nutrition and initiation of studies on MGI 650, a drug that eliminates excess ammonia resulting from liver diseases and cancer cachexia." Suspension of the MGI 136 clinicals came less than a week after the company, a in Feb. 3 press release, expressed confidence in the scientific soundness of the study design. That statement sought to allay investor fears about the future of chemoprotective agents following a setback for U.S. Bioscience's Ethyol before FDA's Oncologic Drugs Advisory Committee ("The Pink Sheet" Feb. 3, p. 3). However, with the announcement of the trial suspension on Feb. 10, MGI Pharma stock dropped 52% of its value in one day. Company CEO Kenneth Tempero sought to reign in any further slide in stock price on Feb. 13 by emphasizing that "MGI Pharma is not a one-product company." He pointed to two oncology products currently marketed by the company, Didronel I.V. Infusion and Oratect Gel. The Minnesota firm plans to file an NDA for Salagen for the treatment of radiation-induced xerostomia (dry mouth) "within the next couple weeks," Tempero noted.

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