NovoNorm® gaining ground in Europe

NovoNorm® was approved in August 1998 for launch in all EU countries. The product has been on the market in the US since April 1998 under the trade name PrandinTM.

Since approval in August 1998, sales of NovoNorm® have developed satisfactorily in the EU. Market shares of 2-4% have been acquired only a few months after introduction in important markets. Overall growth rates, particularly in Germany and Scandinavia, suggest that an understanding of the concept of prandial glucose regulation (PGR) is spreading.

The challenge of PGR
Meals represent the greatest challenge to the beta cell. Insulin secretion must increase rapidly to reach an eight- fold maximum within the first 10-30 minutes of food intake and decline rapidly afterwards to reach basal levels before the next meal. If beta-cell function fails, blood glucose levels will rise and remain elevated, which leads to the development of Type 2 diabetes.The concept of PGR focuses on this fundamental problem and aims to restore meal-related insulin secretion in patients with Type 2 diabetes towards that of healthy individuals.
As an established part of the management of Type 2 diabetes, sulphonylureas are often used as insulin secretagogues. However, the sulphonylureas are not well suited for prandial glucose regulation due to their slow- acting nature. They are unable to deliver pulses of insulin matched to meal-induced glucose peaks.

NovoNorm® features
NovoNorm® is the first beta-cell mediated prandial glucose regulator for the treatment of Type 2 diabetes. It is an effective first-line monotherapy and is also approved for combination therapy. NovoNorm® is taken immediately before a meal and if a meal is skipped - so is the tablet. All Type 2 patients can use NovoNorm® and it is also effective in patients with reduced liver or renal function.

Market growth factors
In 1998, growth of the global OAD market reached 26% (value). The driving force behind this growth was 43% growth in the US.
The European diabetes care market, which accounts for almost half the world’s patient population, is characterised by a strong commitment to tight blood glucose regulation and multiple daily treatment regimens.

NovoNorm® has been launched in the UK, Germany, Denmark, Sweden and a number of other EU countries.

This means that there is significant potential for NovoNorm® in Europe, where the 'one meal; one dose - no meal; no dose' concept will be easy to explain to both the medical profession and patients.
Five-year projections of the world market for OADs suggest an annual growth rate in the order of 15-20%. This is partly caused by a rapid increase in the number of people diagnosed with Type 2 diabetes. It is estimated that 215 million people will be diagnosed with Type 2 diabetes in the year 2010 - almost double the number of patients in 1997.
the recent publication of the UK Prospective Diabetes Study (UKPDS), which lasted more than 20 years and involved more than 5,000 patients, has documented that aggressive treatment of diabetes with oral products and insulin will significantly reduce the risk of long-term complications from diabetes.
A very important part of treating diabetes aggressively lies in ensuring patient compliance with the regimens. This is also true for OADs, where a switch is seen from older products to newer, better products that command a higher price. All of these constitute significant sources of growth in the diabetes care market.

German launch successful
An estimated 3.4 to 3.8 million people in Germany have Type 2 diabetes. 50% are treated with various OADs. Novo Nordisk’s strategy in this market is to establish NovoNorm® as the first choice in newly diagnosed patients, and to differentiate the product from sulfonylureas by positioning NovoNorm® as a new class of drug with a specific insulin release profile integrating the 'flexible oral therapy' concept.
This is being done by addressing patients and pharmacies to create customer pull and by generating interest in NovoNorm® at the general practitioner (GP) level - a main target group because GPs are primary prescribers. Germany has about 35,000 GPs, all of whom are being visited by Novo Nordisk’s own representatives.
Before going to the GP level, however, during pre-marketing an advisory board was established with highly regarded specialists to provide support and endorsement for the PGR concept. In addition, about 135 local seminars have been arranged as a follow-up on 14 regional launch symposia.
In the first six months following launch in Germany, NovoNorm® carved out a market share of 3%.

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