Novo-Nordisk-AR-2012-en

• Levemir ® is a soluble, long-acting
modern insulin for once-daily use for
people with type 1 and 2 diabetes.
Levemir ® provides glucose control with
a favourable weight profile.
The primary goal of the company’s research
in diabetes is to discover new therapies that
safely and effectively lower blood glucose
while reducing the risk of low blood sugar
(hypoglycaemia). Tresiba ® and Ryzodeg ®
are the latest outcomes of this effort:
Tresiba ® is a once-daily basal insulin
analogue with an ultra-long duration of
action and a flat and stable action profile
which reduces the rate of low blood sugar
(hypoglycaemia). This also makes it possible
to adjust insulin dosing time when needed.
Ryzodeg ® is a soluble insulin combination
of Tresiba ® and NovoRapid ® (insulin aspart),
providing both basal and mealtime glucose
control. Insulin aspart is marketed under
the brand name NovoLog ® in the US. Read
more about the challenges associated with
insulin treatment on pp 24–25.
Novo Nordisk is also developing a fasteracting
insulin to be taken at mealtimes,
FIAsp, a new formulation of insulin aspart.
The phase 1 proof-of-concept trials for a
number of different formulations of insulin
aspart have been completed and Novo
Nordisk expects to initiate the phase 3a
programme, onset ® , towards the end of
2013.
In addition to new and improved
injectable insulins, Novo Nordisk is
developing formulations of insulin that
can be taken orally as tablets. Encouraging
progress has been made in 2012, but many
technological challenges remain. Read
more about the development of insulin in a
tablet on pp 26–27.
GLP-1 (Glucagon-Like Peptide 1)
– a new class of diabetes treatments
With the launch of Victoza ® in 2009, Novo
Nordisk entered a new segment of the
diabetes care market: GLP-1 therapies.
Victoza ® is a human GLP-1 analogue with
97% similarity to the natural gut hormone.
Victoza ® is taken once daily and, like
natural GLP-1, works by stimulating the
beta cells in the pancreas to release insulin
only when blood sugar levels are high.
GLP-1 therapy is a major innovation
in the treatment of type 2 diabetes
because it lowers glucose with a very
low risk of triggering low blood sugar
(hypoglycaemia).
Victoza ® is approved for adults with
type 2 diabetes who are unable to
achieve blood glucose goals with lifestyle
changes and metformin, the most widely
used tablet for type 2 diabetes). In less
than two years Victoza ® has become the
leading GLP-1 treatment globally and has
steadily expanded the market for GLP-1
treatment. The market is currently valued
at approximately DKK 13.6 billion, of
which Victoza ® accounts for approximately
68%. Available in more than 60 markets,
Victoza ® is now used by approximately
700,000 people worldwide.
OUR BUSINESS 17
Furthermore, a clinical pharmacology
trial investigating the use of liraglutide as
adjunct therapy to insulin in people with
type 1 diabetes, LATIN T1D (liraglutide as
adjunct therapy to insulin in people with
type 1 diabetes) has been completed. The
phase 3 programme, ADJUNCT , which
includes around 2,000 people with type 1
diabetes, will be initiated in the second half
of 2013.
Based on the expertise Novo Nordisk
has obtained through the development
of Victoza ® , the company is now building
a GLP-1 portfolio with the intention
of providing an even broader range
of treatment options. Key projects
include a once-weekly GLP-1 analogue,
semaglutide, which has been approved
for phase 3, and IDegLira, a fixed-ratio
combination of liraglutide and insulin
degludec, which offers the benefits of
both compounds.
Novo Nordisk is also developing
formulations of GLP-1 that can be taken
as tablets.
Injection devices
Novo Nordisk offers the world’s most
widely used durable and disposable devices
for insulin and GLP-1: NovoPen ® 4 and
FlexPen ® , and has recently introduced
its latest innovations NovoPen ® 5 and
FlexTouch ® in many markets. Read more
about injection devices on p 28.
Establish presence in obesity
According to the World Health
Organization (WHO), obesity has reached
pandemic proportions, with up to 1.4
billion adults (over 20 years old) being
overweight or obese. Of these, more than
200 million men and nearly 300 million
women are clinically obese (ie BMI ≥ 30). 2
Obesity is known to be a major risk factor
in developing serious diseases such as type
2 diabetes and cardiovascular disease.
Despite the growing prevalence of
severe and morbid obesity globally, there
are currently only a few medical treatment
options, and reimbursement for these
medications is limited. The market is
currently valued at DKK 1.7 billion.
Novo Nordisk is investigating the use
of once-daily liraglutide 3 mg as a new
way of treating high-risk obese patients,
namely those with obesity-related medical
conditions such as prediabetes, sleep
apnoea, high blood pressure and lipid.
Results of the phase 2 trials and the first
of four phase 3 trials have been reported.
They suggest that liraglutide 3 mg may
have a positive benefit–risk profile.
Gaining regulatory approval for
antiobesity medications is a major
challenge. However, for the first time in
more than a decade, the US Food and Drug
Administration has approved new obesity
medications in 2012.
CONTINuED
NOVO NORDISK ANNUAL REPORT 2012