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| Saforis(TM) NDA Accepted by U.S. FDA for Priority Review; PDUFA Date of October 12, 2006 Established |
MINNEAPOLIS--(BUSINESS WIRE)--June 12, 2006--MGI PHARMA, INC. (Nasdaq:MOGN), today announced that the New Drug Application (NDA) for Saforis(TM) (glutamine in UpTec(TM)) Powder for Oral Suspension has been accepted for priority review by the U.S. Food and Drug Administration (FDA). A Prescription Drug User Fee Act (PDUFA) goal date of October 12, 2006 has been established for review of the Saforis application. Saforis is an investigational drug for the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy. "More than 200,000 patients undergoing mucotoxic cancer therapy in the U.S. develop significant oral mucositis each year," said Lonnie Moulder, President and CEO 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. This NDA filing is a significant regulatory milestone for MGI PHARMA as we execute on our goal of advancing our broad pipeline of product candidates." 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). Adverse events observed in patients treated with Saforis were mild in nature and similar to those observed in patients treated with placebo. The most frequently-observed adverse events among patients in both the Saforis and placebo arms of 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 Oral Mucositis Clinically significant oral mucositis, a common side effect of mucotoxic cancer therapy, is characterized by painful ulcerations, redness and swelling in the mouth. It is estimated more than 200,000 patients in the U.S. develop significant oral mucositis each year, including up to 40% of patients undergoing standard dose mucotoxic cancer therapy and more than 75% of patients receiving high dose chemotherapy with stem cell transplantation or radiation therapy for head and neck cancer. In addition to being difficult for patients to manage, oral mucositis can lead to chemotherapy dose reductions, compromised nutrition due to difficulty swallowing and eating, poorer quality of life, and an increased risk of infection. These consequences can lead to significant morbidity and an increased risk of mortality associated with cytotoxic therapy. Oral mucositis is also associated with higher healthcare costs as a result of hospitalization, administration of antimicrobial therapies, and the use of opioid analgesics to manage pain. About Saforis(TM) Powder For Oral Suspension Saforis(TM) (glutamine in UpTec(TM)) Powder for Oral Suspension is a product candidate for the prevention and treatment of oral mucositis that occurs as a result of mucotoxic cancer therapy. Saforis has not been approved for marketing by the U.S. FDA or any other regulatory agency. An oral formulation of glutamine delivered via MGI PHARMA's proprietary UpTec(TM) 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. About MGI PHARMA MGI 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(R) (palonosetron hydrochloride) Injection, Dacogen(TM) (decitabine) for 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 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.
CONTACT: MGI PHARMA, INC. |
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