Washington Editor

The FDA wants more information on Saforis (glutamine), meaning MGI Pharma Inc. is looking at another study to get the oral mucositis drug approved.

That was the agency's request in an approvable letter issued to the Minneapolis-based company late last week. Specifically, the FDA wants another Phase III trial to test Saforis' ability to treat and prevent the condition that arises from mucotoxic chemotherapy and affects more than 200,000 patients per year in the U.S.

MGI's management couldn't be reached for comment, but in an official statement, President and CEO Lonnie Moulder said the company would evaluate "options to maximize the value of Saforis." However, he conceded that the company's operating plans for next year did not include a significant contribution from Saforis.

That thought was echoed by Analyst Joel Sendek with Lazard Capital Markets in New York. He predicted a delay to market of about two years, into 2009, according to a research note, but removing the product from his model takes away only $10 million and $12.5 million in sales estimates over the next two years.

In the past, though, company management has predicted peak annual sales of about $100 million in the U.S. Of note, Moulder said MGI remains committed to achieving pro-forma operating profitability next year.

The new drug application, which MGI filed in the spring, was based on findings from one pivotal trial and several supportive studies. (See BioWorld Today, April 14, 2006.)

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. Those receiving Saforis experienced a 22 percent relative risk reduction of clinically significant oral mucositis compared to those on placebo (p=0.026), and the incidence of severe oral mucositis was 1.2 percent in Saforis patients compared to 6.7 percent in placebo patients (p=0.005).

Sendek said he continues to believe Saforis is approvable, based on the Phase III data, and predicted that MGI would secure a European partnership for the product in the first half of next year. The company has internal marketing plans for its commercialization in the U.S.

Saforis essentially is a drug-device combination that delivers an oral formulation of the amino acid glutamine via MGI's UpTec system, designed to deliver high concentrations of glutamine into damaged oral mucosa in order to promote healing.

The news initially hurt MGI in the eyes of investors, with the company's stock (NASDAQ:MOGN) losing about 8 percent of its value in overnight trading Thursday before rebounding Friday and trading up by 46 cents to close at $17.91.