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 Novo
Nordisk's first Type 2 product
The premier launch of Prandin/NovoNorm®
(repaglinide), Novo Nordisk's new oral agent for the treatment of Type 2 diabetes, took
place in the United States in early April of this year.
Prandin has been on the fast track for approvals since August 1997, when
the US Food and Drug Administration notified Novo Nordisk that the product had received
priority review status.
A recommendation for approval by the FDA Endocrinologic and Metabolic Drugs Advisory
Committee in November was followed by FDA approval in December.
This is the first country in which the product is available, and it makes Novo Nordisk the
only pharmaceutical company in the US that offers people with diabetes an oral treatment
for Type 2 in addition to insulin for those patients in which it is needed.
Prandin/NovoNorm® is the newest addition to the growing portfolio of products that
makes Novo Nordisk a truly comprehensive diabetes care provider.

NovoNorm® will be presented in Europe in connection
with the EASD to be held in Barcelona in September this year. |
Prandin/ NovoNorm® is the first in a new class of chemically distinct oral
antidiabetic agents that helps people manage their Type 2 diabetes.
Prandin/ NovoNorm® is a potent, fast-acting agent that is absorbed rapidly after
dosing and cleared quickly from the bloodstream. The product is indicated as an adjunct to
diet and exercise to lower the blood glucose in patients with Type 2 diabetes whose
hyperglycaemia (high blood glucose level) cannot be controlled satisfactorily by diet and
exercise alone. It is also indicated for use in combination with metformin to lower blood
glucose in patients whose hyperglycaemia cannot be controlled by exercise, diet or
metformin alone.
The Prandin/NovoNorm® tablet is taken only at mealtime, so if a meal is missed
during the day, the tablet for that meal is not taken; if a meal is added, so is another
tablet. Dosing connected to meals combined with the knowledge that the product works only
when necessary to manage mealtime glucose levels may ultimately help improve compliance
with diabetes treatment regimens.
Prandin has been priced competitively for the US market. Depending on the dose
recommended by physicians, Prandin is priced somewhat higher than sulfonylureas, but
it is lower than the recently released troglitazone.
Copromotion with Schering-Plough
In January, Novo Nordisk and Schering-Plough Corporation announced plans to comarket
Prandin along with Novo Nordisk's full range of insulin products and devices in the
United States. The multi-year copromotion agreement took effect immediately. It will
enable Novo Nordisk to expand its business in the US and increase the ability to access
physicians, other health care professionals, patients and other purchasers.

Advertisements are part of the campaign to make
American doctors and people with Type 2 diabetes realise the advantage of being able to
regulate insulin secretion in relation to food intake. |
Novo Nordisk teamed up with Schering-Plough as a copromotion partner in order to
have access to the support of a recognisable committed, entrepreneurially focused sales
team. It also enhances Novo Nordisk's ability to reach primary care physicians and
strengthens and expands Novo Nordisk's position in the US managed care system due to
Schering-Plough's particularly strong position in this area. The alliance effectively
provides the broadest and most comprehensive collection of diabetes care products and
services in the US. Although historically Schering-Plough has not had a presence in US
diabetes care, Novo Nordisk believes that Schering-Plough's large sales force and strong
overall US presence will mean success for the copromotion agreement. In fact,
Schering-Plough's disease management subsidiary, Integrated Therapeutics Group has been
named Number 1 in disease management for the third consecutive year by the Health
Industries Research Companies Survey of managed care decision makers.
The combination of the companies' field sales representatives will increase dramatically
the competitiveness in the US market place, where Novo Nordisk currently has around 200
sales representatives. By comparison, Schering-Plough with approximately 3,000 sales
representatives currently employs the fifth largest sales force in the US.
Because this agreement significantly increases the number of sales representatives that
will be promoting the company's entire line of diabetes products, Novo Nordisk believes
that sales will increase, translating into a positive impact on the bottom line.

Repaglinide is marketed in the US under the trade mark
Prandin while in the rest of the world it will be known as NovoNorm® |
Promising launch
Prandin was launched during a launch conference with more than 1,000 attendees from
both Novo Nordisk and Schering-Plough in early April. On 6 April, sales representatives
across the nation began to introduce Prandin to their physicians, beginning with a
targeted approach to endocrinologists then expanding to primary care physicians. These
sales efforts are supported by journal ads and other activities designed to educate
physicians about this new class of drug in the treatment of Type 2 diabetes.
Initial physician reaction to Prandin has been positive. The key message they are
receiving is that the rapid absorption and elimination of Prandin provides
insulin-releasing power when patients need it, and may pose fewer health risks than drugs
whose longer half-lives keep them active in the body longer. Physicians appreciate this
physiologic action and consider it a more natural approach to Type 2 treatment.
The market for Type 2 diabetes
Type 2 diabetes is a major and serious health care problem affecting approximately 120
million people worldwide. The number is growing at a rate of 4-6% per year, and it is
estimated that by year 2010 approximately 215 million people will suffer from this
disease. In 1997 the worldwide market for oral antidiabetic agents was USD 2.4 billion, an
increase of 24% compared to 1996. The market for oral antidiabetic agents is expected to
grow by 15-20% annually in the coming years.
In the US, an estimated 16 million people suffer from diabetes. According to the American
Diabetes Association (ADA), more than 5 million adults in the US have undiagnosed Type 2
diabetes. Of the people treated for diabetes in the US, approximately 50% are treated with
oral antidiabetic agents only, 32% are treated with insulin, 8% are treated with a
combination of an oral antidiabetic agent and insulin while 10% are on diet and exercise*).
In 1997, the US market for oral antidiabetic agents was USD 1.3 billion, an increase of
51% compared to 1996.
*) Source: Roper Starch: 1997 US Diabetes Study |