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MGI PHARMA SUBMITS NEW DRUG APPLICATION FOR SALAGEN(TM)

 MGI PHARMA SUBMITS NEW DRUG APPLICATION FOR SALAGEN(TM)
 MINNEAPOLIS, Feb. 24 /PRNewswire/ -- MGI Pharma (NASDAQ: MOGN)


reported that it is submitting a New Drug Application (NDA) today to the Food and Drug Administration (FDA) for the review and approval to market Salagen(TM) (pilocarpine). Salagen (pilocarpine) is a treatment for radiation-induced xerostomia in head and neck cancer patients.
 Dr. Kenneth F. Tempero, MGI Pharma's chairman and CEO, said "The submission of the NDA for Salagen is an important milestone for MGI Pharma. It represents the first prescription drug to be developed and submitted for FDA approval by our company."
 Salagen has been designated an orphan drug for the treatment of radiation-induced xerostomia in head and neck cancer patients. Orphan drugs receive seven years market exclusivity after approval by the FDA. The market potential for Salagen as a treatment for radiation-induced xerostomia has been estimated to be as large as $100 million annually in the United States. MGI Pharma is currently searching for an international marketing partner to market the drug in countries outside North America, particularly in Europe and Japan.
 What is radiation-induced xerostomia?
 Approximately 45,000 people are diagnosed with head and neck cancer in the United States each year. The standard treatment regimen for such cancers is surgical removal of the tumor followed by high doses of radiation to the head and neck region. This massive exposure to radiation, intended to kill the remaining tumor cells, also damages salivary glands and mucus-secreting tissue to the point that they may no longer respond to normal stimuli. The resulting chronic condition is known as radiation-induced xerostomia (dry mouth).
 Post-radiation xerostomia is a permanent, painful, distressing and sometimes debilitating condition that patients must endure for the rest of their lives. Individuals with xerostomia resulting from cancer radiation therapy must alter many daily activities to adapt to their xerostomia. Simple activities such as speaking, eating and sleeping can become painful and difficult. Patients frequently lose all their teeth (often within 24 months), have altered taste and, not infrequently, develop numerous oral hygiene problems which are difficult therapeutic challenges. Patients tend to be continually uncomfortable and constantly seek moisture to relieve the symptoms of xerostomia.
 Current Treatment Options
 Patients and physicians reveals have indicated that the single most common therapy for xerostomia is sipping water. While sipping water does provide some instant relief, it provides no sustained benefits beyond the time the water is held in the mouth. Patients often travel with water containers, eat food with large amounts of water, participate in meetings with water immediately at hand, avoid cold weather, and need to urinate frequently.
 MGI Pharma's Clinical Programs for Salagen
 Salagen, which is pilocarpine hydrochloride, works by stimulating the surviving portion of the salivary glands and mucus-secreting tissue sufficiently so that they once again begin to generate saliva. MGI Pharma conducted extensive research to evaluate pilocarpine's ability to generate saliva to provide relief to xerostomic patients. The company conducted 10 clinical studies. Patients treated with pilocarpine in MGI Pharma's pivotal studies reported that they noticed improvements in dryness, comfort and speaking immediately after taking Salagen. Pilocarpine also produced a significant increase in salivary flow measured as either whole saliva or from parotid gland secretions.
 The primary adverse effect of pilocarpine is sweating. At lesser frequencies by chills, nausea, vomiting, headache, urinary frequency, rhinitis, dizziness, vasodilation, lacrimation, asthenia, diarrhea and dyspepsia have been documented.
 MGI Pharma, Inc., acquires, develops and markets pharmaceuticals prescribed and recommended by physician specialists. The company currently sells DIDRONEL(R) I.V. Infusion and Oratect(TM) Gel.
 -0- 2/24/92
 /CONTACT: Lori Weiman of MGI Pharma, 612-939-4666/
 (MOGN) CO: MGI Pharma, Inc. ST: Minnesota IN: MTC SU:


DS -- MN001 -- 1757 02/24/92 09:32 EST
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