Novo Nordisk Wins EU Panel’s Recommendation for Tresiba

Novo Nordisk A/S won backing from a European Union advisory panel for Tresiba, a rival to Sanofi’s top-selling Lantus insulin, paving the way for increased diabetes-market competition and sending its stock to an all-time high.

Tresiba, also known as insulin degludec, was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use, the London-based agency said in a statement today. The European Commission usually follows the panel’s recommendation. The treatment, approved in Japan last month, is also under review in the U.S.

Novo, the world’s largest insulin maker, needs Tresiba, a long-acting insulin analogue, to wrest market share from Sanofi in the diabetes field. Bagsvaerd, Denmark-based Novo’s older product, Levemir, has been trailing Lantus, which garnered 3.92 billion euros ($5.1 billion) in sales last year.

“This new insulin is key for future growth” at Novo Nordisk, Philippe Lanone and Beatrice Muzard, analysts at Natixis Securities in Paris, wrote in a Sept. 12 note to clients. They estimate Tresiba may deliver annual peak sales of 19.5 billion kroner ($3.4 billion) by 2025.

All-Time High

Novo Nordisk shares rose 2.2 percent in Copenhagen trading to 970.50 kroner, the highest price since the company went public in 1991. The stock has gained 50 percent this year, including reinvested dividends, outstripping an 18 percent gain in the Bloomberg Europe Pharmaceutical Index.

“This is the first insulin approved in Europe at a higher strength than the EU-wide standard,” the EMA said in today’s statement. Tresiba “is expected to respond to the growing need for higher-dose insulin.”

Between 200,000 and 700,000 diabetes patients in the EU currently need higher-dose injections, according to the regulator.

“We are very happy about the positive opinion by the CHMP,” Mads Krogsgaard Thomsen, Novo’s chief science officer, said in an e-mailed statement. Novo is confident it will be able to soon provide Tresiba to patients in Europe, he said.

Diabetes afflicted 366 million people worldwide last year, according to the International Diabetes Federation. Drugmakers are developing new products as the market is likely to grow to more than $58 billion in 2018 from $35 billion now, Standard & Poor’s said on Oct. 4. The disease, caused by a lack of insulin needed to convert blood sugar into energy, can lead to kidney damage, blindness, heart problems and death, if untreated.

Steady Stream

Long-acting insulins such as Lantus seek to replicate the steady stream of the hormone that healthy people produce over 24 hours. Degludec has a longer duration of action than Lantus and can be dosed in a more flexible way, according to Novo.

The U.S. Food and Drug Administration this year extended the review period for Tresiba. The agency plans an advisory committee meeting on Nov. 8 to discuss the medicine’s benefits and disadvantages.

“Assuming no further delays in the U.S., Novo should have Tresiba approved in the U.S., Europe and Japan during the first quarter of 2013,” Lars Hevreng, an analyst with SEB Enskilda in Stockholm, wrote in a Sept. 3 note to clients.

Sanofi shares were down 1.3 percent in Paris trading.

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