* CFO sees Tresiba U.S. launch in 3-5 years
* Some analysts say launch could be even later
* Q1 EBIT 7.6 bln DKK vs 7.39 bln forecast
* Nudges up 2013 full-year sales growth guidance
* Shares flat vs firmer Copenhagen index
By Mette Fraende and Shida Chayesteh
COPENHAGEN, May 1 Denmark's Novo Nordisk
could see the U.S. launch of its biggest drug hope, a
new long-acting insulin, delayed until 2018 while it conducts
more tests to satisfy regulators, it said on Wednesday.
The world's biggest insulin producer was dealt a major blow
in February when the U.S. Food and Drug Administration (FDA)
refused to approve the drug, called Tresiba, and instead asked
for extra tests to assess potential heart risks.
On Wednesday, a clarification of the expected timetable for
the drug's progress disappointed analysts, some of whom said the
launch could be even later than Novo's estimates.
"This points to a potential approval in 2017 at the absolute
earliest, with 2021 on a worst-case scenario," Jefferies said in
a note to clients.
The setback for Tresiba, also known as degludec, is good
news for rival makers of insulin medicines, notably France's
Sanofi, whose Lantus product is threatened by Novo's
newer ultra-long-lasting treatment.
The big concern for Novo's investors, though, is that a
lengthy delay in getting Tresiba launched in the world's biggest
drugs market will undermine its ability to stay ahead of rivals
such as Sanofi and Eli Lilly.
Novo said it expected to start cardio-vascular trials with
Tresiba within one year. Data to support an interim analysis
would be available after two to three years, the company said.
"Assuming that you will have a response from the FDA of the
refiling within about half a year, then it (the launch) should
be more in the three, maybe five year (timeframe) in the worst
case scenario," finance chief Jesper Brandgaard said.
That would point to a launch of Tresiba in 2016 at the best
and in 2018 at the worst.
Analysts had been expecting Tresiba and Ryzodeg, another of
Novo's insulins, to be selling around $2.8 billion a year by
2017, according to consensus forecasts compiled by Thomson
Reuters Pharma. Those numbers look set to fall sharply, since
the U.S. market made up more than half of the forecast.
Brandgaard also said the cost of the cardiovascular trials
was expected to be $200-300 million over four to five years.
UPS SALES VIEW
Novo also nudged up its 2013 sales forecast, the second time
in three months, after first-quarter sales and operating profit
The profit rise was driven by a higher-than-expected 14
percent increase in sales of modern insulins, and a 35 percent
rise in sales of diabetes drug Victoza, which was however
slightly below forecasts.
Novo said it now expected 2013 sales growth in local
currencies of 9-11 percent, against 8-11 percent previously.
It kept its forecast for operating profit growth of around
10 percent, also in local currencies.
Some analysts had hoped for bigger upgrades.
"Seen in the light of the strong performance in the first
quarter, full year expectations look conservative and might
disappoint some investors," said Nordea in a note.
At 0810 GMT, Novo shares were flat at 993.5 Danish crowns,
within a benchmark Copenhagen index up 0.3 percent.
Novo made a first-quarter operating profit of 7.6 billion
crowns on sales of 20 billion.