Pipeline updates are highly awaited events in the pharma/biotech
sector as they play an important role in deciding whether or not to
invest in a particular company. These updates provide information
on experimental drugs and at times give an insight into the
commercial potential of the candidate once it is successfully
developed and commercialized.
) type II diabetes candidate, Xultophy (IDegLira), received a
positive opinion from the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP). Xultophy is
a once-daily single injection combination of Novo Nordisk's Tresiba
(insulin degludec) and Victoza.
The CHMP recommended the approval of Xultophy for the treatment of
adults suffering from type II diabetes in combination with
glucose-lowering oral drugs, when such drugs (alone or combined
with basal insulin) fail to achieve adequate glycemic control.
A response from the EC is expected by Oct 2014. Novo Nordisk
intends to launch Xultophy in Europe in the first half of 2015.
We are encouraged by the CHMP's opinion on Xultophy and believe
chances of gaining approval are high. Although the European
Commission (EC) is not bound to accept the recommendations of the
CHMP, it usually does so.
We note that in two phase III studies (DUAL I and II), patients
treated with Xultophy experienced a lower rate of hypoglycemia,
compared to Tresiba. The patients also achieved body weight
reduction compared to basal insulin treatment.
We remind investors that Novo Nordisk's Victoza 3mg is also under
review in the EU for the treatment of adults suffering from obesity
and overweight adults with comorbidities such as hypertension,
dyslipidemia, sleep apnea or type II diabetes.
Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked
stocks in the health care sector are Allergan Inc. (
), AbbVie Inc. (
) and AstraZeneca plc (
). While Allergan carries a Zacks Rank #1 (Strong Buy), AbbVie and
AstraZeneca hold a Zacks Rank #2 (Buy).
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