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Novo shares fall after split safety ruling

SHARES in Novo Nordisk fell as much as 13 percent yesterday after a United States advisory panel handed the drug maker a split ruling on whether its diabetes medicine Liraglutide was safe to be marketed.

The Danish firm said it still expected the US Food and Drug Administration to finally approve Liraglutide and that it would continue to work closely with the agency over the next few months.

"We still expect Liraglutide to be approved," said Mads Krogsgaard Thomsen, Novo's executive vice president and chief science officer.

The Food and Drug Administration's outside experts voted six to six when asked if thyroid tumors found in tests of rats and mice should prevent sales of the drug. One panel member abstained.

Novo's shares were trading down 10.5 percent at 251.50 Danish crowns (US$45.45)yesterday in Copenhagen, following a 4.3-percent fall on the New York Stock Exchange on Thursday. The US market closed before all of the panels' votes had been reported.

The final decision now rests with the FDA. Industry analysts view Liraglutide as a potential blockbuster and a key driver for Novo's growth.

Thomsen said the company remained convinced Liraglutide had a positive risk-benefit profile and that he expected the FDA would soon schedule a meeting with Novo to discuss three potential topics: a general approval, a risk management plan and post-approval studies.

"We remain committed to bring Liraglutide to the market for the benefit of people with type-two diabetes," Chief Executive Lars Sorensen said.

Thomsen said he expected a decision within a few months.


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