MGI Pharma Inc. filed for FDA approval of Saforis, an oral formulation of the amino acid glutamine, for the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy.
"There is no FDA-approved drug to assist with chemotherapy-induced oral mucositis," Jim Hawley, MGI's chief financial officer and a senior vice president, told BioWorld Today. "We're very excited to be able to bring something to the market that will be very beneficial to patients."
The Minneapolis-based company requested a priority review for the fast-track product, and an FDA decision on the review duration will come in about two months.
The new drug application was based on findings from one pivotal trial and several supportive studies of the product, which essentially is a drug-device combination. Saforis is an oral formulation of glutamine delivered via MGI's UpTec system, designed to deliver high concentrations of glutamine into damaged oral mucosa in order to promote healing.
The Phase III study, which included 326 breast cancer patients who were receiving anthracycline-based chemotherapy regimens, met its primary endpoint of reducing the incidence and severity of oral mucositis.
Specifically, those receiving Saforis experienced a 22 percent relative risk reduction of clinically significant oral mucositis compared to those on placebo (p=0.026). In addition, the incidence of severe oral mucositis was 1.2 percent in Saforis patients compared to 6.7 percent in placebo patients, another significant reduction (p=0.005).
Saforis treatment side effects were mild and similar to placebo, and the most frequent adverse events in the study were nausea and vomiting.
Oral mucositis, a common side effect of mucotoxic cancer therapy that occurs in more than 200,000 patients per year in the U.S., is characterized by ulcerations, redness and swelling in the mouth. MGI said that the need for glutamine is critical when oral mucosa has been injured as a result of chemotherapy or radiation, so by exposing the mucosa to increased concentrations of the amino acid, Saforis may promote healing and prevent damage to the lining of the mouth.
Although oral mucositis can resolve itself in 10 days to two weeks, "in that period of time it can be extremely difficult for patients," Hawley said. Sometimes the condition can lead to infections, and in some instances, oncologists lower chemotherapy doses or halt the treatment altogether because of oral mucositis.
Enter Saforis, which could fill a therapeutic void and generate peak annual sales of about $100 million in the U.S., Hawley said. The company has internal marketing plans for stateside commercialization down the road, assuming positive regulatory feedback. For its commercialization in Europe, MGI plans to find a partner and presently is involved in such discussions. A regulatory filing there likely would follow a marketing partnership, he added.
Saforis "fits very well" into MGI's supportive care franchise for oncology, Hawley said, which features Aloxi (palonosetron hydrochloride) Injection, a marketed drug for the prevention of chemotherapy-induced nausea and vomiting. First-quarter sales of that product, the company disclosed on Thursday, are expected to total about $63 million, a sequential decrease in use blamed on fewer emetogenic chemotherapy administrations and a continued competitive market. MGI's full quarterly financial results are scheduled for release next week.
Also among the company's oncology products is the Gliadel Wafer (polifeprosan 20 with carmustine implant), which is sold for high-grade malignant gliomas. In late-stage development for cancer is Dacogen (decitabine), for myelodysplastic syndromes and acute myelogenous leukemia.
On Thursday, shares in MGI (NASDAQ:MOGN) gained 21 cents to close at $16.34.