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Positive Data on Novo Nordisk's N9-GP

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Novo Nordisk (NVO) recently announced positive phase III data on its hemophilia B candidate, N9-GP, from the paradigm 2 study.

Paradigm 2 evaluated N9-GP, a long-acting FIX derivative, for on-demand or prophylactic treatment of hemophilia B patients. Results indicated that the once-weekly prophylactic administration of N9-GP could lower the risk of bleeds by more than 90% compared to on-demand treatment. Moreover, 99% of the few occurring bleeds could be stopped with a single dose

The paradigm program includes 7 studies evaluating the pharmacokinetics, immunogenicity, efficacy and safety of N9-GP in adult and pediatric hemophilia B patients as well as in patients undergoing surgery.

In the coming twelve months, Novo Nordisk expects the two remaining phase III studies in the paradigm program to be completed. N9-GP is expected to be filed for approval in all major markets by 2015.

Currently, the hemophilia market is crowded with drugs like Advate, Xyntha, Recombinate and Kogenate FS.

We note that Biogen Idec’s (BIIB) hemophilia B candidate, Alprolix, is currently under FDA review. With the FDA granting standard review, a response from the agency regarding the approval status of Alprolix should be out in the fourth quarter of this year.

Novo Nordisk has a strong presence in the diabetes care market. The Diabetes Care segment recorded growth of 15% in 2012 with sales coming in at DKK 60.9 billion. Modern Insulins generated strong revenues(up 15%) driven by NovoRapid (up 16%) and Levemir (up 21%). 2012 results were driven by strong revenues from NovoRapid, Levemir and Victoza. Victoza witnessed sales growth of 58% in 2012.

Novo Nordisk currently carries a Zacks Rank #3 (Hold). Currently, companies like Santarus, Inc. (SNTS) and Salix Pharmaceuticals Ltd. (SLXP) look more attractive with a Zacks Rank #1 (Strong Buy).

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