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Positive CHMP Opinion for NVO Candidate - Analyst Blog

By: Zacks.com
Posted: 9/23/2013 5:53:00 PM
Referenced Stocks: BAYRY;BIIB;CHMP;NVO;RHHBY

Novo Nordisk A/S ( NVO ) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its hemophilia A candidate, NovoEight.

Novo Nordisk is looking to get NovoEight approved in the EU for the treatment and prevention of bleeding in patients with hemophilia A.

A final decision on NovoEight should be out shortly. With the CHMP adopting a positive opinion, we expect NovoEight to gain EU approval. The company expects to launch the candidate in early 2014. It has also filed for approval in the U.S., Japan, Australia and Switzerland.

The filing was based on the guardian program, enrolling about 210 patients suffering from hemophilia A. The phase III studies, namely, guardian 1 and guardian 3, included previously treated adults and children with severe hemophilia A. Roughly 350,000 patients across the world have hemophilia A.

We are encouraged by Novo Nordisk's progress in developing treatments for hemophilia. Novo Nordisk also has 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 remaining two phase III studies in the paradigm program.

Currently, the hemophilia market has drugs like Advate, Xyntha, Recombinate and Kogenate FS. Biogen Idec Inc. ( BIIB ) is currently looking to get its hemophilia A candidate, Eloctate, approved in the U.S.

Novo Nordisk currently carries a Zacks Rank #2 (Buy). Other large cap pharma stocks that look well-placed include Bayer ( BAYRY ) and Roche Holding ( RHHBY ). Roche carries a Zacks Rank #1 (Strong Buy) while Bayer carries a Zacks Rank #2.



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