Novo Expects U.S. Approval for Lantus Rival in First Half

(Updates with CFO comments from third paragraph.)

Jan. 31 (Bloomberg) -- Novo Nordisk A/S, the world’s largest insulin maker, said it’s counting on the new diabetes medicine Tresiba to get U.S. approval in the first half, helping buoy sales growth this year.

The Danish company is making progress on talks with the U.S. Food and Drug Administration on Tresiba and will need to do a study about cardiovascular effects once the medicine is on the market, Chief Executive Officer Lars Sorensen said on a conference call with reporters today. Novo has no indications it would be required to do another study before approval, he added. That would have meant a delay for the diabetes treatment.

Novo is “a train on the rails and moving steadily forward,” Chief Financial Officer Jesper Brandgaard said in a phone interview today. U.S. approval for Tresiba will be the “key swing factor” in 2013.

Novo aims for the product to eventually become the world’s top-selling long-acting insulin, overtaking Sanofi’s Lantus, which garnered 3.92 billion euros ($5.3 billion) in sales in 2011. Bagsvaerd, Denmark-based Novo earlier today lifted its 2013 revenue and profit forecasts, on higher demand for its existing diabetes treatment Victoza and optimism for Tresiba.

In the U.S., the required study will begin as Novo starts marketing the medicine, Sorensen said. The FDA hasn’t told Novo when its review will end. Novo will start selling Tresiba in the U.S. “almost immediately” after FDA approval, he said.

Tresiba Label

Heart risks with Tresiba, also known as insulin degludec, probably aren’t enough of a concern to block its approval, an advisory committee for the FDA ruled in November. Sorensen declined to comment on negotiations over the drug’s label with the FDA. Medicine labels highlight their risks and a warning on them can affect sales.

The stock traded 0.5 percent higher at 1,026 kroner at 1:43 p.m. in Copenhagen. The shares have returned 55 percent in the past 12 months, compared with a 23 percent gain in the Bloomberg Europe Pharmaceutical Index.

The medicine will be introduced in Europe in about the same time frame as in the U.S., starting by countries such as Denmark, the U.K, Ireland, Switzerland and the rest of Scandinavia, Brandgaard said during the interview.

“We got a phenomenal label in Europe,” where Tresiba received approval earlier this month, Sorensen said. “That is influencing our ability to market it in many other local markets in Asia.”

Price Premium

In Europe, Novo is aiming for a price premium for Tresiba over Lantus that is “higher” than 5 percent or 10 percent, and could be in the range of 30 percent to 40 percent, Brandgaard said.

“We will be seeking a significant price premium over the current products,” he said. “The EU price setting is not final yet.”

The pricing of Tresiba in Europe is a “hot topic,” Peter Sehested, an analyst at Handelsbanken Capital Markets in Copenhagen wrote in a Jan. 28 note. Novo needs to sell Tresiba at a price that “includes a premium for innovation.”

“A fully reimbursed premium of 20 percent or above would imply upside to expectations” and be a “strong” signal that regulators consider Tresiba a “genuine improvement,” he wrote.

Novo’s revenue will probably rise 8 percent to 11 percent excluding currency shifts as operating profit on that level gains about 10 percent, Novo said today. The drugmaker previously forecast growth of those two measures at a “high single-digit” percentage pace.

Fourth-quarter net income rose 23 percent to 5.76 billion kroner ($1.1 billion), Novo said. That beat the 5.34 billion- kroner average of analysts’ estimates compiled by Bloomberg.

--Editors: Thomas Mulier, Marthe Fourcade