The share price of
) continued to increase following approval from the U.S. Food and
Drug Administration (FDA) for its hemophilia A candidate,
NovoEight is approved in the U.S. for treating adults and
children with hemophilia A for control and prevention of
bleeding, perioperative management and routine prophylaxis to
prevent or reduce the frequency of bleeding episodes.
Novo Nordisk sought approval for NovoEight from the FDA based
on results from the guardian program. The program enrolled more
than 210 patients suffering from hemophilia A. Novo Nordisk
stated in its press release that roughly 350,000 patients across
the world have hemophilia A.
Novo Nordisk is likely to launch NovoEight in the U.S. after
Apr 2015, that is, after the expiration of existing patents. The
company did not provide details regarding the same.
The European approval of NovoEight in the hemophilia A
indication is on track with the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) rendering a
favorable opinion on the issue. It has also filed for approval in
Japan, Australia and Switzerland.
We are encouraged by Novo Nordisk's progress in developing
treatments for hemophilia. Novo Nordisk also has N8-GP in its
pipeline. N8-GP, a hemophilia A candidate, whose phase III study
is scheduled to finish in the first half of 2014.
Another candidate, N9-GP, for the treatment of hemophilia B is
in phase III development. The company expects to file N9-GP for
approval in 2015, after the completion of the two phase III
studies in the paradigm program.
Currently, the hemophilia market has drugs like Advate,
Xyntha, Recombinate and Kogenate FS.
Biogen Idec Inc.
) is currently looking to get its hemophilia A candidate,
Eloctate, approved in the U.S. Biogen expects approval for
Eloctate in the second quarter of 2014.
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Currently, companies like
AMAG Pharmaceuticals Inc.
) look attractive with a Zacks Rank #1 (Strong Buy).
AMAG PHARMA INC (AMAG): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
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