* U.S. FDA feedback on Victoza delayed to Q4
* Novo says delay has no impact on full-year guidance
* Shares drop 3.2 percent
(Adds details, quotes, updates share price)
By John Acher
COPENHAGEN, Sept 23 (Reuters) - Formal feedback from the U.S. Food and Drug Administration on Novo Nordisk's candidate diabetes drug Victoza has been delayed to the fourth quarter, the Danish drugmaker said on Wednesday.
Novo Nordisk had earlier said it expected feedback from the FDA on Victoza, also known as liraglutide, by the end of the third quarter.
It said the delay did not affect its 2009 outlook, but Novo Nordisk shares fell and analysts said it added uncertainty over whether Victoza could reach the market before Eli Lilly's competing diabetes treatment.
"Novo Nordisk continues the constructive dialogue with the FDA regarding the regulatory process for liraglutide," the company said in a statement.
Novo Nordisk spokesman Mike Rulis said the delay was due to a large workload at the FDA and not to snags in the process.
"It is not a sign that new things have come up or that complications have emerged," he said. "It is simply a sign that the process takes the time that the process takes."
Novo Nordisk shares dropped 3.3 percent at 321 crowns by 1131 GMT, underperforming a 1 percent drop in the Copenhagen bourse's bluechip index.
When Novo Nordisk reported second-quarter results in August, analysts expressed disappointment that it did not have more progress to report on the Victoza approval.
Jyske Bank analyst Frank Horning Andersen said: "We expect that Victoza will continue to be delayed in relation to the initial expectations of a launch in 2009."
Andersen added that he thought Victoza would be on the U.S. market in 2011.
RIVALRY
Victoza would be a rival to Eli Lilly's long-acting Byetta LAR diabetes treatment.
Sydbank analyst Rune Dahl said Victoza would be on the market later than had been hoped in the rivalry with Byetta LAR, which he said Eli Lilly could probably bring out in May 2010.
"So they don't have so big a headstart that one otherwise could have counted on," Dahl said.
"It is obviously bad for the commercial potential not to be able to build up the market and get some patients for Victoza before there is a real competitor out on the market," he said.
"It will also mean increased uncertainty for Victoza in general because the FDA cannot reach a decision," Dahl added.
Novo said business prospects this year are unaffected.
"This update on the timeline for formal feedback on liraglutide from the FDA does not change Novo Nordisk's expectations for the company's financial results for 2009," it said, referring to the outlook given last month.
On Aug. 26, the company raised its forecast for growth of full-year 2009 earnings before interest and tax (EBIT) in local currencies to 12-14 percent from an earlier projection of at least 10 percent.
Novo Nordisk said it aimed to give an update on the regulatory process in its third-quarter report on Oct. 29 if formal feedback from the FDA is not received before then. (Additional reporting by Peter Levring and Henriette Jacobsen; Editing by David Cowell and Jon Loades-Carter)