MGI Pharma Inc. has submitted a new drug application to theFood and Drug Administration for Salagen, a treatment forradiation-induced dry mouth in head and neck cancer patients.It is the first drug to be developed and submitted formarketing approval by the Minneapolis company.
If approved, Salagen "could very likely be the drug that turnsMGI Pharma profitable," said company spokeswoman LoriWeisman. The company lost $8.7 million in 1991 and earlierthis month suspended trials of its MGI 136 chemoprotectiveagent, causing its stock to lose more than half its value.
The shares (NASDAQ:MOGN) gained $1.25 to $13.25 on Monday.
Radiation treatment for head and neck cancer damages salivaryglands and mucus-secreting tissues. The resulting xerostomiacan make speaking, eating and sleeping difficult and painful,and can cause patients to develop oral hygiene problems, losetheir teeth and have altered taste. Salagen (pilocarpinehydrochloride) is administered regularly to stimulate thesurviving salivary glands and mucus-secreting tissues togenerate saliva.
Salagen has orphan drug designation. The market for thisapplication is estimated at $100 million, Weisman said. MGI isseeking an international partner to market the drug incountries outside the United States.
MGI also is considering developing Salagen as a treatment forSjogren's syndrome, an autoimmune disease that causesxerostomia, and has filed an orphan drug application for thisindication.
Salagen's primary side effect is sweating. Less frequentreactions, including chills, nausea, vomiting, headache, urinaryfrequency, rhinitis, dizziness, vasodilation, lacrimation,asthenia, diarrhea and dyspepsia, have also been documented.
Meanwhile, the future of MGI 136 "hopefully could be decidedby the end of March or so," Weisman told BioWorld. Thecompany "is collecting the data we need to analyze before wecan decide what the future should be for that drug."
MGI 136 was in Phase III tests of its ability to reduce the toxiceffects of cisplatin, a chemotherapeutic, and to stimulate bonemarrow. The company halted the trials because patientsreceiving the therapy were dropping out of the trial faster thanpatients on a placebo.
The company is also considering developing its MGI 650ammonia scavenger to help liver patients or cancer patientssuffering from cachexia (general wasting) collect and eliminateexcess ammonia.
MGI has acquired and is marketing Didronel, an intravenousinfusion for treating hypercalcemia of malignancy. Thecompany is considering developing Didronel for treatment andprevention of the onset of severe osteoporosis in totalparentaral nutrition patients -- those who cannot take nutritionorally. It has received separate orphan drug designations forthe treatment and prevention applications.
The company also is marketing Oratect Gel, a topical analgesicfor oral mucositis (mouth ulcers). -- Kris Herbst
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