Saforis is a patented, topical, oral suspension of glutamine that utilizes a proprietary formulation to protect oral mucosa from damaging effects of chemotherapy. Glutamine is the most abundant amino acid in human plasma and has multiple beneficial functions in the human body. The availability of and demand for glutamine becomes critical when oral mucosa has been injured from chemotherapy. Increased levels of glutamine in mucosal tissues may prevent damage from cancer treatments and help tissues recover normal function.

A phase 3 trial of Saforis has been completed in breast cancer patients. MGI PHARMA submitted a New Drug Application (NDA)for Saforis to the Food and Drug Administration (FDA) during the second quarter of 2006. MGI PHARMA received an approvable letter for Saforis from the FDA in October 2006.

About Oral Mucositis

Oral mucositis, a common side effect of chemotherapy and radiation therapy, is characterized by painful ulcerations, redness and swelling in the mouth. More than 20% of patients undergoing myelosuppressive chemotherapy develop oral mucositis. Patients with severe oral mucositis may have difficulty swallowing and eating.

Patients and health care providers seeking information regarding clinical trials may call MGI PHARMA toll-free at 1-800-562-5580 and press 1 to access our Medical Communications Help Line.