Pipeline Setback at Novo Nordisk

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Denmark based Novo Nordisk (NVO) recently announced that it will terminate the development of its phase III hemophilia candidate, vatreptacog alfa. Vatreptacog alfa, a fast-acting recombinant factor VIIa analogue, was being developed for haemophilia patients with inhibitors.

The company’s decision followed the analysis of data from a double-blinded, randomized, controlled phase IIIa (adept 2) study. The trial enrolled 72 haemophilia patients with inhibitors. Patient received either vatreptacog alfa or NovoSeven, an approved product of Novo Nordisk.

On August 9, 2012 along with the first half 2012 results, Novo Nordisk announced that findings from the adept 2 trial. It was observed that a few patients developed anti-drug antibodies to vatreptacog alfa and a potentially neutralizing effect was observed in a patient.

We note that Novo Nordisk also received some positive news recently when Tresiba (insulin degludec) received 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.

In August 2012, the First Committee on Drugs of Pharmaceutical Affairs, advisory body of MHLW had passed Tresiba. The company expects to launch Tresiba on the completion of price negotiations in Japan, where Tresiba will be available in Novo Nordisk’s insulin pens, FlexTouch and Penfill.

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. We note that the US Food and Drug Administration (:FDA) has scheduled an advisory panel meeting on November 8, 2012. We are encouraged by the approval of Tresiba in Japan. US approval of the drug would be a major boost for the company.

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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