SOURCE: Novo Nordisk A/S

June 24, 2008 03:05 ET

Novo Nordisk A/S - Regulatory Approval

Novo Nordisk receives approval in the US for PrandiMet™

BAGSVAERD, DENMARK--(Marketwire - June 24, 2008) - Novo Nordisk receives approval in the US for PrandiMet™

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved PrandiMet™, a fixed-dose combination of the fast-acting insulin secretagogue repaglinide and metformin for the treatment of type 2 diabetes.

PrandiMet™ has been approved as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes who are already treated with a meglitinide (such as Prandin®) and metformin or who have inadequate glycaemic control on a meglitinide alone or metformin alone.

"As the world's leading diabetes care company, Novo Nordisk is dedicated to providing a broad portfolio of treatments that respond to each stage of diabetes. With PrandiMet™, physicians will have a simplified option for Prandin® and metformin combination therapy," said Jerzy Gruhn, president, Novo Nordisk, Inc.

About PrandiMet™

PrandiMet™ is indicated for the treatment of type 2 diabetes and includes two approved products with well established data for safety and efficacy: repaglinide (Prandin®) and metformin. It is the first fixed-dose combination of repaglinide, a fast-acting insulin secretagogue, and metformin, an insulin sensitiser. PrandiMet™ combines two antihyperglycaemic agents with different mechanisms of action in one tablet to improve glycaemic control. PrandiMet™ works to control three abnormalities of type 2 diabetes: impaired insulin secretion, insulin resistance and excessive hepatic glucose production.

PrandiMet™ is available in two dosage strengths - 1mg (repaglinide)/500mg (metformin) and 2mg (repaglinide)/500mg (metformin), dosed 2-3 times per day with meals.

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 26,300 employees in 80 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For more information, visit

Contacts for further information:

Media:                 Investors:

Outside North America: Outside North America:
Mike Rulis             Mads Veggerby Lausten
Tel: (+45) 4442 3573   Tel: (+45) 4443 7919

                       Hans Rommer
                       Tel: (+45) 4442 4765

In North America:      In North America:
Sean Clements          Christian Qvist Frandsen
Tel: (+1) 609 514 8316 Tel: (+1) 609 919 7937

Stock Exchange Announcement no 39 / 2008

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