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NEW YORK/ZURICH, Nov 19 (Reuters) - U.S. regulators have requested more data on Novartis AG's NOVN.VX promising cancer drug Afinitor and a decision on approval is expected to be delayed by three months, the Swiss drugmaker said on Wednesday.
Afinitor is one of a clutch of promising new medicines highlighted by Novartis at an investor invent on Wednesday as it tries to combat the impending loss of patent protection on its top-selling drug Diovan, a treatment for high blood pressure.
The U.S. Food and Drug Administration has asked for more details on Afinitor -- for which Novartis now expects an approval decision on its use in treating advanced kidney cancer in the first quarter of 2009 -- but no additional studies.
But the strength of the clinical data on Afinitor so far makes WestLB analysts “very optimistic” that the drug will be approved.
Novartis, like many other pharmaceutical stocks, has found some favour in the financial crisis with its shares almost unchanged in the last two months due to its fairly secure earnings and dividend profile.
But the sector faces looming threats from copy-cat generic competition and more difficulties getting new products to market.
Novartis said its exploratory pipeline grew 40 percent since 2005 and it now has 139 projects in clinical development.
“The company has one of the industry’s strongest and most novel pipelines,” said Karl-Heinz Koch, analyst at Swiss brokerage Helvea.
As part of its drive to cushion loss of Diovan sales, Novartis expects to file a single pill combination of blood pressure drugs Tekturna and Diovan in the United States by the end of this year, and in the European Union by 2009.
Novartis also aims for approval of two other combinations including Tekturna before the loss of market exclusivity for Diovan in the United States in September 2012.
The Swiss company also expects to file a treatment for rare but potentially fatal auto-inflammatory diseases called Cryopyrin-Associated Periodic Syndromes before the end of this year.
The company had previously expected submissions for the treatment, ACZ885, in 2009, but brought those forward to late 2008 after promising results from two clinical studies, which showed adults and children achieved rapid and long-lasting clinical remission of these diseases.
Its shares fell 0.9 percent to 57.70 Swiss francs by 1344 GMT, holding up better than the European healthcare sector, which was down 2.2 percent .SXDP. (Editing by John Stonestreet and Jon Loades-Carter)
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