NVO Presents Degludec Data - Analyst Blog
July 01 2011 - 11:00AM
Zacks
Recently, Novo Nordisk (NVO) presented data
from late stage trials, which showed that its ultra-long acting
insulin Degludec lowered blood glucose levels with significantly
reduced risk of hypoglycemia (low blood sugar) versus
Sanofi Aventis’(SNY) Lantus in patients with type
II diabetes.
Novo Nordisk presented data from two, late stage, 52-week
clinical trials, one in patients with type I and the other in
victims of type II diabetes. These data were presented at the
American Diabetes Association.
Degludec particularly reduced nocturnal hypoglycemia (night-time
episodes of excessively low blood sugar) versus Lantus in patients
with type I or type II diabetes. Nocturnal hypoglycemia is highly
feared by diabetics, and hence a reduced threat of it represents a
real commercial edge for Degludec. Apart from the two studies, Novo
Nordisk also presented data from a 26-week study, which revealed
that Degludec can be given at different times of the day in
patients with type II diabetes.
Degludec is Novo Nordisk’s most important pipeline product in
addition to DegludecPlus. Degludec (also known as NN 1250) and
DegludecPlus (also known as NN 5401) are next-generation insulin
analogues. Degludec is an ultra long-acting basal insulin and
DegludecPlus is a fixed ratio combination of Degludec and
NovoRapid.
Novo has conducted a large late stage, clinical program with
Degludec and DegludecPlus consisting of 17 separate trials. The
program included 12 trials under the BEGIN program (Degludec) and 5
under the BOOST program (DegludecPlus). All the 17 trials have now
been completed and data from the trials, which studied more than
10,000 type 1 and type II diabetes patients, confirmed the safety,
efficacy and convenience of both the pipeline candidates. The
company expects to file applications for marketing authorization of
the candidates in both US and EU in the second half of 2011.
Our Recommendation
We currently have a Neutral recommendation on Novo Nordisk. The
stock carries a Zacks #3 Rank (short-term “Hold” recommendation).
Novo Nordisk holds an impressive market share of the global insulin
market by volume. We are impressed by Novo Nordisk’s biggest drug
Victoza’s performance thus far. Victoza is doing well both in the
US and Europe. Moreover, we believe that the diabetes pipeline
candidates, Degludec and DegludecPlus, also hold significant
importance for long-term growth at Novo Nordisk. We are encouraged
by the positive data from Degludec trials that will ensure the
approval of the candidates.
However, the impending competition from Bydureon, which has been
co-developed by Amylin Pharmaceuticals (AMLN),
Eli Lilly and Company (LLY) and Alkermes
Inc. (ALKS), concerns us. We prefer to remain on the
sidelines until we get better visibility on the performance of
Bydureon on launch and its subsequent impact on Victoza sales.
ALKERMES INC (ALKS): Free Stock Analysis Report
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
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