SaforisTreatment for Mucositis
MGI Pharma Announces Submission of Saforis NDAMINNEAPOLIS -- April 13, 2006 - MGI PHARMA, INC. (Nasdaq:MOGN), today announced that the New Drug Application (NDA) for Saforis (glutamine in UpTec) Powder for Oral Suspension has been submitted to the U.S. Food and Drug Administration (FDA) for review. Saforis, an oral formulation of glutamine in a proprietary delivery system designed to increase uptake of glutamine by the oral mucosa, is an investigational drug for the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy.
"The submission of the Saforis NDA marks a key milestone for MGI PHARMA as we execute on our goal of advancing our pipeline of product candidates," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "We look forward to working closely with the FDA during the review process in order to bring this important supportive care product to cancer patients as quickly as possible."
One pivotal phase 3 trial and several supportive studies form the foundation of the Saforis NDA. The pivotal phase 3 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. Data indicated that patients receiving Saforis experienced a 22% relative risk reduction of clinically significant (World Health Organization or WHO Grade 2 or higher) oral mucositis compared with placebo (p=0.026). In addition, the incidence of severe oral mucositis (WHO Grade 3 or higher) was significantly reduced in Saforis patients when compared to placebo (1.2% vs. 6.7%; p=0.005). Side effects of Saforis treatment were mild in nature and similar to placebo. The most frequently-observed adverse events in this study were nausea and vomiting. Results of this study were first presented at the American Society of Clinical Oncology (ASCO) 2004 Annual Meeting.
About Saforis Powder For Oral SuspensionSaforis (glutamine in UpTec) Powder for Oral Suspension is a product candidate for the prevention and treatment of oral mucositis as a result of mucotoxic cancer therapy. Saforis has not been approved for marketing by the U.S. FDA or any other regulatory agencies. An oral formulation of glutamine delivered via MGI PHARMA's proprietary UpTec system, Saforis is designed to deliver high concentrations of the 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 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.
About Oral MucositisOral mucositis, a common side effect of mucotoxic cancer therapy, is characterized by painful ulcerations, redness and swelling in the mouth. It is estimated that approximately 35% of patients undergoing mucotoxic cancer therapy develop significant oral mucositis, which equates to more than 200,000 patients per year. Although it is a common condition, patients with solid tumors and their caregivers have few therapeutic options to treat oral mucositis. In addition to being difficult for patients to manage, oral mucositis can lead to chemotherapy dose reductions and an increased risk of infection, and is also associated with higher healthcare expenses as a result of the frequent use of opioid analgesics to manage mucositis-related pain, emergency room visits and longer hospital stays.
About MGI PHARMAMGI PHARMA, INC. is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi (palonosetron hydrochloride) Injection and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. The Company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the FDA not accepting the Saforis NDA for review, the FDA not approving Saforis for commercialization in the United States, the FDA requiring additional clinical studies prior to approving Saforis, and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements.
Posted: April 2006
- MGI Pharma Receives Approvable Letter for Saforis (Glutamine) Powder in UpTec for Oral Suspension - October 12, 2006
- Saforis NDA Accepted by U.S. FDA for Priority Review - June 12, 2006