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UPDATE 1-Novartis sees FDA decision on Menveo early 2010

Wed Jul 1, 2009 5:42am EDT

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* US regulator seeks more data on meningitis vaccine

Stocks  |  Regulatory News

* Company expects to provide full response in 2009

* No new clinical trials necessary

(Adds analyst, company comments, background, shares)

ZURICH, July 1 (Reuters) - Novartis (NOVN.VX)said it expects the U.S Food and Drug Administration to rule on the Swiss pharmaceuticals company's Menveo meningitis vaccine in early 2010 after the regulator sought more information about the treatment.

The FDA'S request is part of the regulatory procedure, Novartis said on Wednesday, adding that no new clinical trials would be required for the vaccine, which analysts view as a potential blockbuster.

The group expected to answer all the FDA's questions fully in 2009.

"We will be able to respond relatively quickly. We already have the data," a Novartis spokesman said.

Menveo, which the firm wants to sell to adults and adolescents, is one of two Novartis vaccines against meningococcal infection in late-stage development viewed as potential best-sellers. The other is MenB 1.

In January, the company said U.S. regulators asked for a late-stage trial of Menveo for use in infants to be expanded. Filing of Menveo for use in infants is now expected in 2011, Novartis said.

"After the infant application (Menveo vaccine age 2-11) needing to perform an additional safety trial in 1,500 infants, we view the delay of the adolescent and adult vaccine as a disappointment," said Vontobel analyst Andrew Weiss in a research note.. Novartis shares were flat at 0912 GMT, underperforming the European Healthcare Index.SXDP which was up 0.75 percent.

(Reporting by Martin de Sa'Pinto and Paul Arnold; editing by John Stonestreet)



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