First approval of NovoRapid™

NovoRapid™ (NovoLog™ in the US) is Novo Nordisk's new rapid-acting insulin analogue. The EU authorities approved NovoRapid™ in September 1999. The international launch of NovoRapid™ took place during the EASD in Brussels at the end of September 1999.

Insulin analogues - insulins that have been modified in order to meet certain characteristics - are the most recent addition to the increasingly competitive global diabetes care market.
NovoRapid™, Novo Nordisk's new rapid-acting insulin analogue, has now been approved by the EU authorities 13 months after the application was submitted to the EMEA (European Medicines Evaluation Agency) in August 1998.
NovoRapid™ is the second rapid-acting insulin analogue to reach the market.

Commercial potential
NovoRapid™ will be promoted on all glycaemic parameters where it has shown an improvement over human soluble insulin.
Compared with human soluble insulin, NovoRapid™ represents an improvement in overall glycaemic control: faster absorption, more predictable response, better postprandial blood glucose levels, and less hypoglycaemia. NovoRapid™ also represents an improvement in insulin administration, as people with diabetes can now inject themselves right before a meal. Previously, they had to wait to eat until 30 minutes after an injection. Furthermore, NovoRapid™ will be available for administration in Novo Nordisk's superior injection devices which will further facilitate the market penetration of this new product.
NovoRapid™ will be targeted at all people with diabetes who require mealtime insulin therapy, for example basal/bolus users, and later by pump users once this indication has been approved by regulatory authorities.
The arguments for switching existing users of short-acting insulin or other insulin analogue users to NovoRapid™ are better glycaemic control and convenience, and an improved basal/bolus therapy using the same advanced devices for both day and night injections.
NovoRapid™ is the only product of its kind to have shown significant long-term improvements of glycaemic control compared to soluble human insulin in large longterm clinical trials. This is in addition to other improvements in glycaemic control parameters: improved postprandial control, smoother 24-hour control and a 50% risk reduction of major nocturnal hypoglycaemia. Furthermore, NovoRapid™ will be marketed for use in all Novo Nordisk's advanced administration systems including NovoPen^® 3 and Innovo™.

Insulin market
From 1994 to 1998 the world insulin market increased by an annual rate of approximately 3-4% measured in volume, reaching more than 130,000 MU (MegaUnits) insulin in 1998. The United States accounted for 47% and Europe 43%, while the remainder can be attributed primarily to Japan with 5%.

Industrialised World Insulin Market
1994 - 1998 (MU)

Soluble market
Soluble insulins are insulins that are not supplied as suspensions. Soluble insulin covers short-acting insulins such as Actrapid^® and rapid-acting analogues such as NovoRapid™. In 1998, soluble insulin sales represented 22% of the total world insulin market. Worldwide, the soluble insulin segment represented a total value of DKK 3,130 million - an increase of 9.4% over 1997. In volume terms, the market was 24,867 MU in 1998. The European soluble market is the largest regional market, accounting for 49% of all soluble sales.
Even in the US, where the total insulin market decreased, soluble insulin sales increased in 1998. The strong performance of soluble insulin can be partially explained by increased focus on mealtime insulin therapies and the launch of another rapid-acting insulin analogue.

Industrialised World Soluble Market Split
1998 (MU)

Products for every need
With the launch of NovoRapid™, Novo Nordisk reclaims its historical leadership in the diabetes care market. The company offers the most complete range of products and services - a factor that makes Novo Nordisk the preferred partner for health care providers and the diabetes medical profession as well as people with diabetes. Novo Nordisk is the only company that supplies all types of insulin, advanced and versatile injection devices, the world's thinnest and shortest needles, an oral drug for Type 2 diabetes, as well as blood glucose monitoring devices, educational literature and disease management systems.

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