2nd UPDATE: Novo Nordisk Shares Slump On Drug Launch Fears
April 03 2009 - 7:51AM
Dow Jones News
Shares in Novo Nordisk A/S (NOVO-B.KO) slumped Friday amid fears
that U.S. regulators would delay the launch of its potential
blockbuster diabetes drug Liraglutide.
Late Thursday, an expert panel of the U.S. Food and Drug
Administration came to a split vote on whether data on a type of
thyroid tumors seen in rodent studies permitted marketing of the
drug.
Despite the setback, the Danish pharmaceutical company's chief
executive Lars Rebien Sorensen said on a conference call Friday
that Novo Nordisk is still committed to bringing Liraglutide to the
market. He said the company recognizes the FDA panel's concerns,
and will continue to work closely with the regulator over the next
months.
"We believe that an approval is likely," Chief Scientific
Officer Mads Krogsgaard Thomsen told Dow Jones Newswires on Friday.
"Data...make us extremely convinced that we're talking about a
phenomenon that is seen in rodents but not in humans."
He said all treatments in Liraglutide's GLP-1 analogue drug
class have shown the same kind of cancerogenic impact on rodents,
so that the entire market for GLP-1 analogues will be hit if the
FDA finds the effect to be relevant to humans.
The FDA is widely expected to take the expert panel's opinion
into account when it later decides on whether to approve a launch
in the U.S., which Novo Nordisk sees as Liraglutide's most
important potential market.
Novo Nordisk Chief Financial Officer Jesper Brandgaard said it's
now uncertain whether Liraglutide will be launched by mid-2009, as
was previously expected by the company, but added that the
immediate financial impact in 2009 of a delayed launch will be
limited.
At 1313 GMT, shares in Novo Nordisk were down 12% at DKK248.50,
underperforming a 1.8% drop in the wider market in Copenhagen.
Analyst Rune Majlund Dahl at Sydbank said investors fear that
the FDA may demand pre-approval safety tests for Liraglutide, which
may delay the drug's launch. He said a complete block of
Liraglutide is unlikely, but that the drug's commercial appeal may
be hit if it is labeled with a cancer warning. Majlund Dahl
maintained his overweight rating for the stock.
Still, UBS reiterated its buy rating for Novo Nordisk and said
its current share price already overly discounts a negative outcome
for Liraglutide. UBS predicted that the FDA will make its decision
on the drug by mid-2009.
Liraglutide, also known under the marketing name Victoza, is
seen as Novo Nordisk's most important drug under development. Jyske
Bank has previously predicted its sales to peak in 2015 at 8.2
billion Danish kroner ($1.5 billion), compared with Novo Nordisk's
total group sales of DKK46 billion in the full year 2008.
Company Web site: http://www.novonordisk.com
-By Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3099;
gustav.sandstrom@dowjones.com