UPDATE 1-SuperGen drug fails trial; likely delay to European nod
Tue Jul 1, 2008 12:32pm EDT Reutera
By Esha Dey
BANGALORE, July 1 (Reuters) - SuperGen Inc (SUPG.O: Quote, Profile, Research, Stock Buzz) said preliminary efficacy data from a late-stage trial of its blood-disorder treatment failed to meet its main goal, potentially delaying European approval of the drug and sending its shares down 15 percent to their lowest level in five years.
The treatment, Dacogen, which mainly competes with Celgene Corp's (CELG.O: Quote, Profile, Research, Stock Buzz) Vidaza, received approval from the U.S. Food and Drug Administration in 2006.
Though the trial was mainly designed for European regulators, a positive result could have made the company go for a label expansion application in the United States, Chief Executive James Manuso told Reuters by phone.
The data did not show a statistically significant advantage of Dacogen treatment on median survival compared to the best supportive care in elderly patients with myelodysplastic syndromes (MDS), or certain blood disorders that often precede leukemia.
"The Dacogen failure is a material positive for Celgene, as Vidaza is now likely to take a commanding share of the MDS market," J.P. Morgan analyst Geoffrey Meacham said in a note.
"Commercially, it will be difficult to justify writing a Dacogen Rx, given the trial failure in the context of Vidaza's robust survival benefit," Meacham added.
Dacogen was developed by SuperGen and licensed to MGI Pharma Inc, which was recently acquired by Japan's Eisai Co Ltd (4523.T: Quote, Profile, Research, Stock Buzz), in a 20-year deal involving royalty payments.
MGI Pharma sublicensed all Dacogen rights outside of North America to Janssen-Cilag, a Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) unit.
CEO Manuso said Eisai, which is conducting several clinical trials on Dacogen, is planning to submit a supplemental new drug application of Dacogen to U.S. health regulators by the end of this year based on other trial data.
SuperGen stands to receive royalties of 20 percent to 30 percent on the net worldwide sales of Dacogen, irrespective of the indications for which it is sold. The company continues to expect royalty revenue of $32 million to $35 million in 2008. It also reaffirmed its 2008 loss outlook of $17 million to $19 million.
The company's stock fell to $1.66, before recouping some losses to trade down 30 cents at $1.75 midday Tuesday on Nasdaq. Shares of rival Celgene were up about 4 percent at $66.26. (Editing by Amitha Rajan)
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So ~ASCO chatter was correct.
edit: I see one in CELG already. |
