Novo Nordisk Falls as FDA Panel to Discuss Insulin Risks

Novo Nordisk A/S, the world’s biggest insulin maker, fell the most in more than 14 months after U.S. regulators disclosed that an advisory panel on the company’s Tresiba diabetes treatment will focus on heart risks.

Novo retreated 3.3 percent to 930 kroner in Copenhagen trading today, the steepest single-day drop since Aug. 18, 2011. The Bagsvaerd, Denmark-based company flagged investors to a document late yesterday that revealed topics for a previously scheduled Food and Drug Administration meeting Nov. 8 to help determine whether Tresiba should be approved for sale.

Novo needs the new medicine to wrest market share from Paris-based Sanofi’s best-selling Lantus insulin, which last year generated 3.92 billion euros ($5.1 billion) in revenue. Diabetes treatments have come under more scrutiny since sales of GlaxoSmithKline Plc’s Avandia were restricted because of heart attack risk.

There is a 70 percent chance that Tresiba will be approved in the U.S. with the obligation for Novo to conduct a cardiovascular study once the medicine is on the market, Jeffrey Holford, an analyst with Jefferies & Co., wrote in a note yesterday. Should the FDA require such a study before the approval, there would be a “substantial multiyear delay” to Tresiba reaching the U.S. market, Alistair Campbell, an analyst at Berenberg Bank, wrote in a report today.

Japan, EU

“There is no cause for concern based on what we know” on Tresiba, Mads Krogsgaard Thomsen, Novo’s chief science officer, said in a phone interview today. “This product is approvable. Whether that is with or without a post-approval cardiovascular outcomes study commitment, it’s a different story.”

Tresiba, also known as insulin degludec, has been approved for sale in Japan and won the backing of a European Union advisory panel on Oct. 19.

Regulators in Japan, Europe and the U.S. had access to the same data on Tresiba, Thomsen said today. The FDA may conduct its own analysis on that data, he added, without elaborating.

Novo is preparing for the Nov. 8 meeting and wasn’t aware a waiver document would be published yesterday, Thomsen said. The Danish company hasn’t yet received questions from the FDA regarding the meeting, he said.

‘Excess Risk’

“Meta-analyses of several clinical trials suggest an excess risk for cardiovascular events with this insulin over its comparators,” the FDA wrote in the document, an Oct. 11 waiver for a panel member with a conflict of interest in the meeting.

The FDA panel also will discuss Tresiba’s benefits, according to the waiver. The medicine may be associated with a lower risk of hypoglycemia, a condition when the blood sugar is too low, than other insulin, the waiver says.

“It will be difficult for the FDA to ignore cardiovascular risk if there is even a hint of it in the data,” Erik Gordon, a business professor at the University of Michigan in Ann Arbor who studies the drug industry. “The question is whether the FDA will assess the risk using the data already collected, imposing a short delay in the approval process, or will require new clinical trials, imposing a long, expensive delay.”

Tresiba sales could reach $9 billion in 2016, according to the average estimate of eight analysts surveyed by Bloomberg.

“A major setback for Tresiba in the U.S. would be unexpected but calamitous, given Novo’s reliance on it to grow share,” Brian Bourdot, an analyst at Barclays Plc’s investment-banking unit in London, wrote in a report today.

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