Denmark-based Novo Nordisk (NVO) is seeking regulatory approval for its hemophilia A candidate turoctocog alfa (NN7008). Novo Nordisk submitted its application for the candidate both in the US and the EU. The company is looking to get turoctocog alfa, a third-generation recombinant coagulation factor VIII, approved for the prevention and treatment of bleeding in patients suffering from hemophilia A.
Novo Nordisk’s marketing authorization application for the candidate was based on positive results from its phase III trials, guardian 1 and guardian 3. The guardian trials, which ended last year, enrolled more than 200 people having hemophilia A and was the largest clinical pre-registration trial program conducted for the disease.
Novo Nordisk is planning to submit regulatory applications in other countries as well in the coming months.
We remind investors that the company suffered a pipeline setback last month. Novo Nordisk decided to terminate the development of its phase III hemophilia candidate, vatreptacog alfa. Vatreptacog alfa, a fast-acting recombinant factor VIIa analogue, was being developed for hemophilia patients with inhibitors.
Novo Nordisk’s decision followed the analysis of data from a double-blinded, randomized, controlled phase IIIa (adept 2) study, where patients received either vatreptacog alfa or NovoSeven, an approved product of Novo Nordisk.
The hemophilia A market currently has players like Bayer AG (BAYRY), Pfizer Inc. (PFE) and Baxter International Inc. (BAX).
We note that Novo Nordisk received positive news last month when Tresiba (insulin degludec) gained approval in Japan. The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tresiba, a next-generation, once-daily basal insulin, for the treatment of type I and type II diabetes. The Japanese approval marks the first approval for Tresiba, which is under regulatory review in several countries including the US, the EU, Switzerland, Canada, South Africa, India, Australia, Brazil, Mexico and Russia.
Our Recommendation
We have an Outperform recommendation on Novo Nordisk. The stock carries a Zacks #1 Rank (Strong Buy rating) in the short term.
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