) 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
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
) 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
Salix Pharmaceuticals Ltd.
) look more attractive with a Zacks Rank #1 (Strong Buy).
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