* FDA advisory panel recommends approval
* Decision despite possible cardiovascular risk
* Novo says labelling key to commercial potential
* Shares jump nearly 10 percent
By Shida Chayesteh and Mia Shanley
COPENHAGEN, Nov 9 Denmark's Novo Nordisk
sees strong commercial potential for degludec, its
long-acting insulin, which is poised to receive the green light
from U.S. regulators.
Shares in the company rose 10 percent on Friday morning
after a U.S. Food and Drug Administration (FDA) panel on
Thursday night recommended approval of the drug, despite
possible cardiovascular risk.
Novo has estimated that degludec, which will be marketed
under the brand name Tresiba, could become a blockbuster drug,
generating more than $1 billion in sales within five years of
"I think the commercial potential is going to be significant
in the U.S.," Chief Executive Officer Lars Rebien Sorensen said
on an analysts' call.
The labelling of the drug in the United States, where Novo
expects to generate the bulk of future sales, will be key. It
said on Friday that talks with regulators about the labelling
are expected to begin soon.
"Until we see that final wording and how that might
translate into market material, of course, we should be a little
careful about estimating what the commercial potential is,"
Shares in Novo Nordisk, the world's biggest insulin
producer, climbed nearly 10 percent in early trade and were up
8.9 percent at 1005 GMT.
Tresiba is central to Novo's aim of ending Sanofi's
dominance of the long-acting insulin market. It
expects to launch the new product in several European markets
early next year, subject to final approval.
The drug has already been approved by regulators in Japan
and the FDA rarely goes against its advisory panel's
recommendations when making its final decision.
The advisory panel said on Thursday that it was concerned
about a trend toward higher incidence of cardiovascular events
with degludec than other drugs in 16 large clinical trials, even
though the difference was not statistically significant.
However, it expressed enthusiasm for the drug's 24-hour
duration of action, saying that it would allow patients to take
the insulin at a different time of the day if they missed taking
it at their usual times.
Mads Krogsgaard, Novo Nordisk's chief science officer, said
he did not expect labels in Europe or Japan to mention the
Novo expects costs for additional cardiovascular studies on
the drug to amount to about 1.5 billion Danish crowns ($256
million) over the next six years.
Sanofi's drug Lantus has 80 percent of the market for
long-acting insulins. U.S. drugmaker Eli Lilly is
developing a similar medicine that is a few years behind in