Novo Nordisk A/S (NOVOB), the world’s largest insulin maker, said it’s counting on the new diabetes medicine Tresiba to get U.S. approval during 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 the medicine and will need to study cardiovascular effects once Tresiba is on the market, Chief Executive Officer Lars Sorensen said on a conference call with reporters today. Novo has no indications it will be required to do another study before approval, he said. 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 telephone interview. U.S. approval for Tresiba will be the “key swing factor” in 2013, he said.
Novo is betting the product will 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, Sorensen said. Novo also raised its 2013 revenue and profit forecasts, amid higher demand for Victoza, another diabetes drug, and optimism for Tresiba.
In the U.S., the required study will begin as soon as Novo starts selling the medicine, Sorensen said. The FDA hasn’t told Novo when its review will end. The Bagsvaerd, Denmark-based company will introduce Tresiba “almost immediately” after FDA approval, he said.
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 fell 1 percent to 1,011 kroner in Copenhagen. The shares have returned 53 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 today’s 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.”
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, the company said today. The drugmaker previously forecast growth at a percentage in the high single- digits for the two measures.
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.
The Danish company also said today it’s developing a new experimental insulin, dubbed LAI287, which would be administered once a week.
“It’s in the early stages,” Philippe Lanone, an analyst at Natixis Securities in Paris, said in a telephone interview today. “A once-weekly insulin shot would be great.”
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