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MGI PHARMA'S SALAGEN(R) TABLETS "APPROVABLE" BY FDA; PRODUCT TREATS RADIATION-INDUCED DRY MOUTH IN HEAD AND NECK CANCER PATIENTS

 MINNEAPOLIS, Dec. 29 /PRNewswire/ -- MGI Pharma, Inc. (NASDAQ: MOGN), a pharmaceutical company, announced today that it has received an approval letter for its product, Salagen(R) Tablets, from the Food and Drug Administration (FDA). Salagen(R) Tablets, which are a new treatment for radiation-induced dry mouth in head and neck cancer patients, will be cleared for marketing by the FDA after a safety update report is submitted by MGI and product labeling is finalized. Approval also requires a commitment by the company to undertake various studies to be initiated and completed following product launch.
 Dr. Barry Steiger, MGI's vice president of medical affairs, stated, "We are obviously very happy with being notified of the approvable status of Salagen(R) Tablets. We will continue to work closely with the FDA to address the few remaining items as quickly as possible, particularly since we believe that there is a growing interest among doctors and patients to try this product. Since August of this year, when the second of our pivotal clinical trials was published in the New England Journal of Medicine, our clinical group and the FDA have processed approximately 100 compassionate use requests, which I believe is significant for a product of this type."
 Dr. Kenneth F. Tempero, MGI's chairman and chief executive officer, stated that, "Not only are Salagen(R) Tablets an important new pharmaceutical product, it is also very important to the overall development of MGI as a pharmaceutical company. Revenues from this product are expected to eventually turn our company profitable. We look forward to such growing revenue streams allowing us to expand our current development efforts."
 Approximately 40,000 people in the United States are diagnosed with head and neck cancer each year. Treatment usually includes surgery and/or high doses of radiation therapy to the head and neck area. While radiation treatment often is effective in controlling the cancer, it damages the salivary glands leaving patients with a chronic dry mouth that is often painful and debilitating. Patients with this condition frequently experience difficulty eating, talking and sleeping as well as a significant increase in dental caries, periodontal disease, and oral infections.
 Salagen(R) Tablets represent a significant improvement in the treatment of radiation-induced dry mouth. Until now, patients have sought temporary relief for their dry mouth by using water, sugar-free hard candies, and saliva substitutes. Salagen(R) Tablets work by stimulating the residual functioning tissue in the damaged salivary glands to increase saliva production, thereby providing patients with a more satisfactory therapy for their chronic dry mouth.
 MGI Pharma conducted several studies to support the use of Salagen(R) Tablets to treat radiation-induced dry mouth. In these studies, Salagen(R) Tablets, when used daily, were found to help increase saliva flow and overall mouth comfort. The results of MGI's two large, well-controlled studies in cancer patients were published in the June 1993 issue of the Journal of Clinical Oncology and the Aug. 5, 1993 issue of the New England Journal of Medicine.
 MGI Pharma acquires, develops and markets pharmaceuticals. Its goal is to develop innovative products that significantly improve the treatment for a variety of serious medical conditions.
 -0- 12/29/93
 /CONTACT: Lori Weiman of MGI Pharma, Inc., 612-939-4666/
 (MOGN)


CO: MGI Pharma, Inc. ST: Minnesota IN: MTC SU:

TM -- NY004 -- 7692 12/29/93 07:29 EST
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Date:Dec 29, 1993
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