Biotech Values

[DewDiligence]

FDA Review of NVS’ Galvus Extended 3 Months

[The new PDUFA date is late Feb 2007.]

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20061113:MTFH14257_2...

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Mon Nov 13, 2006 1:35 AM ET

ZURICH, Nov 13 (Reuters) - Novartis AG <NVS> has asked the U.S. Food and Drug Administration to extend its review period for diabetes drug Galvus by three months to consider new clinical trials data, the Swiss company said on Monday.

The new results provide further evidence that skin problems in a preclinical animal study have not been seen in clinical studies with patients treated for Type 2 diabetes, Novartis said in a statement.

"It was our decision," said Novartis spokesman John Gilardi "It's a setback but we're still confident of getting it to the market quickly."

The Food and Drug Administration review period for the oral drug has been extended from end-November until the end of February 2007.

Novartis still hopes to launch Galvus next year in the United States, in a neck-and-neck race with rival Merck & Co Inc's <MRK> Januvia, which gained FDA approval last month.

Galvus and Januvia are competing intensely to enter the lucrative market of oral treatments for Type 2 diabetes.

Both have been touted by analysts as potential $1 billion-a-year plus sellers.

They represent the first of a class of drugs called DPP-4 inhibitors, which work by enhancing the body's own ability to lower blood sugar levels.

Analysts believe DPP-IV drugs are likely to become a popular treatment in the oral anti-diabetes market, since they are not associated with weight gain, a major side effect of many diabetes drugs.
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