MGI/SuperGen's myelodysplastic syndromes therapy Dacogen could post $25 mil. in sales in the remainder of 2006 following FDA approval May 3, MGI Pharma said.

Within four to five years, Dacogen could reach its peak sales potential of $250 mil., CEO Lonnie Moulder said. The firm is preparing to launch decitabine at the end of May.

FDA approved Dacogen (decitabine) injection for treatment of patients with MDS, including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes and intermediate-1, intermediate-2, and high-risk groups. Dacogen has orphan drug status.

MGI submitted the NDA for the new molecular entity in November 2004, but received an "approvable" letter from FDA in September 2005 seeking additional analysis of transfusion data (¹ Also see "MGI/SuperGen’s Dacogen Is “Approvable” Pending Transfusion Data Analysis" - Pink Sheet, 1 September, 2005.).

The firms are touting Dacogen's efficacy in particular. According to Moulder, "all patients who responded to Dacogen treatment became or remained infusion-independent and had improved quality-of-life scores for several parameters."

The exec lauded the approved ² labeling for Dacogen, which includes a 21% response rate in the pivotal Phase III study of "patients with pathologically confirmed MDS at baseline who remained on Dacogen for two or more cycles." The control group - patients treated with supportive care alone - reported a 0% response rate.

Additionally, "data from the two Phase II studies, which were included in the product label, indicate that the response rate for Dacogen-treated patients plus supportive care were 26% and 24%," Moulder said.

Common adverse events, according to labeling, include neutropenia, thrombocytopenia, anemia, fatigue, pyrexia and nausea.

MGI plans to expand Dacogen's approval beyond the orphan MDS indications. The drug is also currently being tested for use to treat acute myeloid leukemia and chronic myelogenous leukemia.

Competition in the MDS market, which is seen as a stepping stone into the larger leukemia markets, has heated up in the last year.

In December, FDA approved Celgene's Revlimid (lenolidomide) for treatment of patients with transfusion-dependent anemia due to low or intermediate-1 MDS. Labeling for Revlimid includes a "black box" warning regarding potential for birth defects; FDA also required the firm to establish a thorough risk management program, RevAssist (³ Also see "Revlimid Reproductive Safety Concerns Led To Broad Risk Management Plan" - Pink Sheet, 18 April, 2006.).

Dacogen will also compete with Pharmion's Vidaza (azacitidine), which posted $47.1 mil. in sales in 2004. Vidaza, which cleared FDA in 2004, was the first therapy approved for MDS.

-Kathleen Michael

MGI/SuperGen’s Dacogen On Deck For Late May Launch

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