A Negative for SuperGen, a Plus for Celgene

Anticancer company SuperGen (SUPG Quote - Cramer on SUPG - Stock Picks) said Tuesday that its Dacogen failed a late-stage trial in patients with myelodysplastic syndromes (MDS) -- news that may lend advantage to competitor Celgene's (CELG Quote - Cramer on CELG - Stock Picks) Vidaza, which will be relaunched this fall.

According to preliminary data from the phase III study, Dacogen injection didn't demonstrate a statistically significant advantage for the median survival time to best standard of care in elderly patients with MDS, a group of bone-marrow diseases that limit the production of functional blood cells.

However, the company said response rates in the 233-patient study -- despite a lack of statistical significance -- were similar to those seen in other trials in MDS. SuperGen and partner MGI Pharma (which was acquired by Eisai) will present the full data and the secondary efficacy endpoints at an upcoming forum.

Dacogen was approved by the U.S. Food and Drug Administration in 2006 and is indicated for the treatment of patients with both previously treated and untreated MDS.

The drug competes with Celgene's Vidaza. "Key issue in the past is that the two drugs, Celgene and Pharmion's Vidaza and Dacogen were the 'same,'" says SummerStreet Research's Tony Caserta. Thus, the way to differentiate between them is in clinical trials, and these results may be enough to change prescribing habits, he says.

The Street had expected Dacogen to register a similar survival benefit to Vidaza, noted Caserta. A nine-month survival benefit (shown in a trial last fall) should be incorporated into Celgene's label for Vidaza for its relaunch in the second half of 2008. The recent SuperGen data may help Celgene beat expectations for Vidaza sales this year, he says.

« Previous Page

1 2

Next Page »