) 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.
NOVO-NORDISK AS (NVO): Free Stock Analysis
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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
We have an Outperform recommendation on Novo Nordisk. The stock
carries a Zacks #1 Rank (Strong Buy rating) in the short term.