MGI RECEIVES APPROVABLE LETTER FOR ORAL MUCOSITIS TREATMENT

MGI Pharma announced it has received an approvable letter from the FDA for Saforis (glutamine) Powder in UpTec for Oral Suspension, an investigational therapy for the treatment and prevention of oral mucositis, a common side effect of mucotoxic cancer therapy. The FDA has requested an additional Phase III trial to evaluate the efficacy of Saforis in the proposed indication.

"Based upon the FDA's request, we will be evaluating options to maximize the value of Saforis," said Lonnie Moulder, president and CEO of MGI. "Our operating plans for next year did not anticipate a significant contribution from Saforis."

The company submitted the new drug application for Saforis in June and it was accepted for priority review. The submission was based on one Phase III trial and several supportive studies. The Phase III trial of Saforis was successfully completed in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met.

An oral formulation of glutamine delivered via MGI's proprietary UpTec system, Saforis is designed to deliver high concentrations of glutamine into damaged oral mucosa in order to promote healing. Although glutamine is the most abundant amino acid in human plasma, the availability of and demand for glutamine becomes critical when oral mucosa has been injured as a result of chemotherapy or radiation. By directly exposing the oral mucosa to increased concentrations of this important amino acid, Saforis may promote healing and prevent damage to the lining of the mouth.