MGI Pharma Announces Publication of Phase 3 Data for Saforis (glutamine) Powder in UpTec for Oral Suspension in Cancer
Saforis is an investigational therapy for the treatment and prevention of oral mucositis in patients receiving mucotoxic cancer therapy. Results of this phase 3 study formed the foundation for the Saforis New Drug Application (NDA). MGI PHARMA received an approvable letter for Saforis from the U.S. Food and Drug Administration (FDA) in October 2006. Based on the FDA's request for an additional phase 3 trial, the Company is currently evaluating options to maximize the value of Saforis.
The pivotal phase 3 trial of Saforis was conducted in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. Patients in this trial were randomized to receive Saforis or placebo during their first chemotherapy cycle. After their first treatment cycle was complete, study participants were then crossed over to receive the alternate treatment during their next cycle of chemotherapy.
The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met. Data from this study indicate that the incidence of World Health Organization (WHO) Grade 2 or higher oral mucositis was significantly reduced in Saforis-treated patients compared to patients who received placebo (38.7 percent versus 49.7 percent; p=0.026). Among those patients that experienced oral mucositis in this study, the incidence of severe oral mucositis (WHO Grade 3 or higher) was significantly lower in the Saforis arm compared with the placebo arm (1.2 percent versus 6.7 percent; p=0.005).
Overall, the data indicated that the safety profile of Saforis was comparable with that of placebo. The most frequently-observed adverse events considered possibly or probably related to the study drug were nausea and dry mouth. No patient experienced a serious adverse event while receiving Saforis.
About Oral Mucositis
Oral mucositis, a common side effect of mucotoxic cancer therapy, is characterized by painful ulcerations, redness and swelling in the mouth, which can cause difficulty swallowing and eating. 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. In addition to being difficult for patients to manage, oral mucositis can interfere with a patient's ability to continue their cancer therapy and may lead to an increased risk of infection. It is also associated with higher healthcare expenses as a result of frequent opioid analgesics used to manage mucositis-related pain, emergency room visits due to complications from oral mucositis and prolonged hospital stays.
About Saforis(TM) (glutamine) Powder in UpTec(TM) For Oral Suspension
Saforis(TM) (glutamine) Powder in UpTec(TM) 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 prevent damage from mucotoxic cancer therapies and 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 prevent damage to and promote healing of the lining of the mouth.
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care 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. MGI PHARMA directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information, 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 ability of MGI PHARMA to continue to increase sales of its marketed products, the ability to successfully commercialize Saforis(TM) / the ability for MGI PHARMA to respond to the FDA's approvable letter, the successful completion of clinical trials for the Company's other product candidates, 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-K and Form 10-Q. MGI PHARMA undertakes no duty to update any of these forward-looking statements.
MGI PHARMA, INC.
Jennifer Davis, 212-332-4381
Susan Silao, 212-332-4364
Posted: January 2007