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One dose at every meal
NovoNormŽ will be the first
oral diabetes product from
Novo Nordisk
Novo Nordisk expects to be able
to launch the company's first oral
diabetes product during 1998
and in this way complete its portfolio
of insulin, oral antidiabetics
and blood glucose monitoring.
NovoNormŽ is the name of the
new medication, which is well
suited for treating Type 2 diabetes.
The generic name of NovoNorm
Ž is repaglinide.
In approximate figures, the
world's people with diabetes can
be divided into about 10%
with Type 1 and about 90%
with Type 2 diabetes. Patients
with Type 1 diabetes
are dependent on insulin injections
several times a day,
while Type 2 diabetes primarily
is a meal-associated
disease often perceived as a
mild type not as severe as
Type 1 diabetes. Control of
meal-associated blood glucose
is crucial in the regulation
of Type 2 diabetes.
"With this in mind, it is
interesting in terms of treatment
as well as economics
that next year, Novo Nordisk
can expect to introduce a
new Type 2 product with a
different and more competitive
profile than existing
Type 2 products in tablet
form," explains Nazeem Mohamed,
Diabetes Care Strategic
Marketing.
One of NovoNormŽ 's key advantages is that it offers insulin - only when it is
required at mealtimes.
Blood sugar in balance
Marianne Kock, project manager
of the team behind NovoNormŽ
for more than five years, points
out that the molecule in NovoNormŽ differs from existing products
for Type 2 patients:
"NovoNormŽ is ingested as a
tablet at mealtimes, and, in lay
man's terms, helps insulin-producing
cells in the pancreas secrete
insulin in a pattern than matches
the body's normal rhythm. This
makes it highly suitable for treating
patients in the early stages
of Type 2."
Kock underlines as one of the
obvious advantages of NovoNormŽ that it is an extremely
fast-working agent with few side
effects, because it is absorbed
quickly by the body and thus
quickly moves out of the
bloodstream.
"Take one dose with each
meal. It can't get easier for
Type 2 patients to regulate their
blood-sugar level," continues
Kock.
Registration
in the EU and the US
In June, Novo Nordisk filed for
registration of NovoNormŽ with
the regulatory authorities in the
EU as well as the US, almost simultaneously.
The comprehensive
new drug applications, over
450 volumes, with all relevant
data on NovoNormŽ were sent
to the US, while a file just as extensive
was also sent to the regulatory
authorities in the EU.
NovoNormŽ was developed in
cooperation with the German
pharmaceutical company Boehringer
Ingelheim. The agent was
in-licensed by Novo Nordisk for
worldwide marketing.
New market
Seen through the 'strategic eyes'
of Nazeem Mohamed, Novo
Nordisk will be embarking on
what in many ways is a brand
new market, when NovoNormŽ
is introduced worldwide in about
a year.
"Not only will we be going into
a new market segment in order
to launch NovoNormŽ , but
we will be approaching an entirely
new target group - family
practitioners. This will mean different
requirements in terms of
marketing, compared with the
diabetes area otherwise, where
we have so far concentrated on
doctors who are specialists in
the fields of diabetes and
endocrinology.
"What is characteristic of the
Type 2 market is that patients are
primarily in contact with their
own family doctors. Therefore,
we need to reach family doctors
when we are marketing NovoNormŽ .
"It is here we will have to exploit
our well-developed network
and reputation with the
medical specialists in the field of
diabetes. Their assessment of
NovoNormŽ will be a signal to
family doctors."
Economically attractive
Mohamed emphasises that the
Type 2 market is attractive,
because it is not dominated
by the products of a single
pharmaceutical company.
At the same time, it is one
of the fastest pharmaceutical
areas for growth.
"The market for tablets
for Type 2 patients has been
dominated for several years
by several older products.
However, recently a number
of new drugs have been launched
at higher prices making
this 'sleepy market'
much more attractive.
"One of the key advantages
NovoNormŽ is that it
offers insulin - only when it
is required at mealtimes.
The other existing products
do not have this profile. We
haven't been out beating
the drum for NovoNormŽ
yet - for good reason - but we
are now underway with extensi-ve
studies in many countries in
order to increase clinical applica-tion
and patient utility. One tablet
in conjunction with each meal
will be enough to regulate
blood sugar in future," concludes
Mohamed.
Hans Lind
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