UPDATE 1-Novo Nordisk upbeat on Tresiba insulin's U.S. prospects

Fri Nov 9, 2012 5:34am EST

* 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 (Reuters) - 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 launch.

"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," Sorensen said.

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 cardiovascular risk.

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 development.