Novo Sticks to Target for First-Half Tresiba Approval in U.S.

Novo Nordisk A/S (NOVOB), the world’s largest insulin maker, stuck to its target of getting U.S. approval for the diabetes treatment Tresiba in the first half as it’s counting on the product to reach higher 2013 forecasts.

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

The required study will begin “imminently, as we start marketing” the medicine, Sorensen said. The FDA hasn’t told Novo when its review will end. Novo will be able to 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 with the FDA ruled in November. Sorensen declined to comment on negotiations over the drug’s label with the FDA. A medicine’s label highlights its risks and a warning on a label can impact its sales.

U.S. approval of Tresiba is “critical,” Brian Bourdot and other analysts at Barclays Plc’s investment-banking unit in London, wrote in a Jan. 25 note to clients.

The stock traded 0.2 percent higher at 1,023 kroner at 9:43 a.m. in Copenhagen. The shares gave returned 55 percent in the past 12 months, compared to a 23 percent gain in the Bloomberg Europe Pharmaceutical Index.

“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.”

Novo said the medicine will be introduced in Europe in about the same timeframe as in the U.S. Tresiba is already approved in Europe, though Novo will need to go through “lengthy” price negotiations with national regulators, Sorensen said. Such talks aren’t necessary in the U.S., he added.

Price negotiations with Japanese authorities for the same medicine are expected to be completed in the first quarter this year, Sorensen said.

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.

To contact the reporter on this story: Albertina Torsoli in Paris at

To contact the editor responsible for this story: Phil Serafino at

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