UPDATE: Novo Nordisk Diabetes Drug Victoza Gets EU Approval
July 03 2009 - 6:01AM
Dow Jones News
Danish pharmaceutical company Novo Nordisk A/S (NOVO-B.KO) said
Friday the European Commission has given market authorization for
its closely-watched diabetes treatment Victoza in the 27 European
Union member states.
Novo Nordisk will launch Victoza in the U.K., Germany and
Denmark during the summer and in other European markets during the
second half of 2009 and throughout 2010.
Victoza, also known as Liraglutide, belongs to a relatively new
kind of diabetes drug class known as GLP-1 analogues. In contrast
to conventional treatment with insulin, the drug doesn't risk
pushing blood glucose dangerously low and it also helps patients to
lose weight.
Analysts and investors have seen significant sales potential for
the drug, which in April was recommended for European approval by a
regulatory committee, only weeks after a Food and Drug
Administration panel reached a split vote on whether to recommend
it for a launch in the U.S.
It is still uncertain whether Victoza will be launched in that
country although Novo Nordisk is in dialogue with the FDA and hopes
for approval "within months."
Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen
told Dow Jones Newswires his company will launch Victoza on the
first European markets in "very few weeks".
He said the drug should gain a strong position on the market for
diabetes treatment since it has proven in tests to be more
efficient compared both with conventional insulin treatment and
with Eli Lilly & Co's (LLY) and Amylin Pharmaceutical's (AMLN)
competing GLP-1 analogue, Byetta.
Still, he said competition is bound to turn more intense. "All
companies want to have a stake in the GLP-1 field," he said. "That
is why it is important for us to have approval now, and market
early."
A launch on the large European market is important for the
company, although only worth about a third of an equivalent U.S.
launch since it tends to be more difficult there to get
reimbursement for expensive drugs, said Alm Brand analyst Michael
Friis Jorgensen. He has a buy rating on Novo Nordisk.
According to Novo Nordisk, Victoza is around 50% more expensive
than modern insulin at a cost per daily use of roughly EUR3.
Novo Nordisk said Friday's European approval doesn't change its
expectations for its financial results in 2009. At 1022 GMT, the
company's shares were down 0.5% at DKK290.50, against a 1% drop in
the broader Copenhagen market.
The market authorization was in line with expectations and
already reflected in Novo Nordisk's share price, which explained
the lack of any significant market reaction Friday, said Alm
Brand's Jorgensen.
Company Web site: www.novonordisk.com
-By Gustav Sandstrom, Dow Jones Newswires; +46-8-5451-3099;
gustav.sandstrom@dowjones.com