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About LEAD(TM) (Liraglutide Effect and Action in Diabetes)

The LEAD(TM) program comprises five randomized, controlled, double-blinded studies plus one open-label head-to-head study against exenatide and involved more than 4,000 patients with type 2 diabetes in 40 countries.

About Liraglutide

Once-daily liraglutide is the first human Glucagon-Like Peptide-1 (GLP-1) analog developed for the treatment of type 2 diabetes. Liraglutide works by stimulating the release of insulin only when blood sugar levels are high. Weight loss with liraglutide is attributed to the fact that it slows gastric emptying and leads to increased satiety after meals. Liraglutide is naturally broken down in the body and does not require renal excretion.

On May 23, 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration (FDA) in the U.S., as well as a marketing authorization application to the European Medicines Agency (EMEA), for the approval of liraglutide for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on July 14, 2008.

On April 23, 2009, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the EMEA adopted a positive opinion, recommending marketing authorization of liraglutide for treatment of type 2 diabetes in Europe.

In the U.S., a regulatory decision is pending.

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 hemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmac
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