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Novo Nordisk Hemophilia-A Treatment Wins EU Panel Backing

Novo Nordisk A/S won backing from a European Union advisory panel for a hemophilia A medicine, a step forward in the Danish company’s plan to expand treatment offerings for the blood-clotting disorder.

Turoctocog alfa was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use, Novo Nordisk said in an e-mailed statement today. The European Commission, the EU’s executive arm, usually follows the panel’s recommendation. The treatment, to be sold under the brand name NovoEight, is also under review in the U.S.

Novo, the world’s largest insulin maker, is seeking to build up its hemophilia product offering, in a bid to diversify from its main diabetes business. The Bagsvaerd-based company, which already sells the hemophilia therapy NovoSeven and is developing other drugs in the area, faced a setback earlier this year when the U.S. Food and Drug Administration rejected the experimental insulin Tresiba.

Turoctocog alfa “won’t be a game changer for Novo,” Philippe Lanone, an analyst at Natixis Securities in Paris, said in a telephone interview today. “It’s on the diabetes front that investors are awaiting the company.”

Diabetes treatments accounted for about 78 percent of Novo’s first-half revenue. NovoSeven generated 11 percent.

Hemophilia is an inherited blood disorder caused by a low levels or absence of a protein essential for blood-clotting. Approximately one in every 5,000 men are born with hemophilia A, according to Novo Nordisk. That means they’re deficient in producing factor VIII protein. Another disorder, Hemophilia B, is less common. Turoctocog alfa, a recombinant factor VIII, may garner 1.5 billion kroner ($272 million) in sales by 2023, according to Lanone’s estimates.

Novo Nordisk was unchanged at 958.5 kroner in Copenhagen trading today. The stock has gained 7.9 percent over the past year, including reinvested dividends, lagging behind a 22 percent gain in the Bloomberg Europe Pharmaceutical Index.

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