Novartis CEO says 'dont expect' Prexige approval

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Novartis CEO Daniel Vasella says it is unlikely that his company's Prexige (lumiracoxib) painkiller will gain FDA approval after being pulled from the market in Australia earlier this year due to safety concerns.

"If you want my opinion, I don't expect we'll get approval," Vasella told investors during an event held in New Jersey to showcase the company's portfolio of drugs, The Wall Street Journal reports.

Prexige was once expected to be a billion-dollar blockbuster for Novartis. That changed after Merck's Vioxx, which belongs to the same COX-2 class of drugs as Prexige, was pulled from the market in 2004.

Recent setbacks for Novartis mean the company doesn't expect to return to double-digit sales growth until the second half of 2008, according to Vasella.

“We had a significant number of disappointments,” Vasella said. We “will have a much less dynamic year in the pharma business in the second half (than in the first), which will affect the group as a whole.”

Setbacks for Novartis have included earlier-than-expected generic competition for the antiviral Famvir and a delay in approval for the diabetes drug Galvus, which was originally expected early in 2007. Novartis now aims to resubmit Galvus for approval in 2009.

Adding to Novartis' woes, in March, the drugmaker was forced to halt sales of its irritable bowel treatment Zelnorm due to cardiovascular safety concerns. Also this year, Novartis lost patent protection on its heart drug Lotrel, about six months earlier than expected. 

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