This month the EU (European Union) have given Novo Nordisk approval to market their latest Diabetes Management tool for persons with Diabetes throughout all the 27 member states.

Victoza® is the brand name approved in Europe for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. The marketing authorisation covers:

• Combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and
• Combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

“This is an important milestone for Novo Nordisk and for the treatment of type 2 diabetes,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “In clinical studies involving more than 6,500 people with type 2 diabetes, Victoza® has been shown to have a significant blood glucose-lowering effect and lead to weight loss, while having a low risk of hypoglycaemia. On this background, we are convinced that Victoza® is a valuable new treatment option for people with type 2 diabetes.”

Novo Nordisk will launch Victoza® in the UK, Germany and Denmark during the summer and in other European markets during the second half of 2009 and throughout 2010.

The marketing approval in Europe does not change Novo Nordisk’s expectations for the company’s financial results for 2009. Novo Nordisk will provide an update on the expectations for the company’s financial results for 2009 on 6 August 2009 in connection with the release of the financial results for the first six months of 2009.

About Victoza®

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

Throughout the clinical development programme, which involved more than 6,500 patients, Victoza® has demonstrated a favourable benefit:risk profile and has been compared to widely used diabetes treatments such as sulphonylureas (SUs) , thiazolidinediones (TZDs), insulin glargine and exenatide.

On 23 May 2008, Novo Nordisk submitted a New Drug Application to the Food and Drug Administration in the US as well as a marketing authorisation application to the European Medicines Agency in Europe, for the approval of Victoza® for the treatment of people with type 2 diabetes. A New Drug Application was also submitted for approval in Japan on 14 July 2008.

In both the US and Japan, 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 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 more than 27,900 employees in 81 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 novonordisk.com.

Novo Nordisk is preparing Victoza for a summer launch into its first European markets, including the UK, after it was recently recommended for approval.

Victoza (liraglutide) is the first once-daily Glucagon-like peptide-1 (GLP-1) analogue developed for type 2 diabetes.

Final marketing authorisation from the European Commission is expected within the next couple of months following a positive opinion from the Committee for Medicinal Products for Human Use.

“We are optimistic that Victoza will soon be approved for patients with type 2 diabetes,” said Viggo Birch, managing director of Novo Nordisk UK and Ireland.

The drug, which works both by stimulating the release of insulin when glucose levels become too high, and by reducing appetite, will then be launched in “selected” European markets including the UK.

There are currently several GLP-1 drugs in development, but the class has picked up some safety concerns.

The US Food and Drug Administration has already expressed concern with Victoza after some patients developed thyroid cancer during clinical studies.

Victoza will rival Lilly’s Byetta (exanatide) and is expected to face stronger competition if the once-weekly injectable version of Byetta currently in development is approved.

The twice-daily version of Lilly’s drug, launched in 2005, ran into problems last year after it was linked with fatal pancreatitis in a handful of patients.

Another potential rival in development is GlaxoSmithKline’s Syncria (albiglutide) and, if successful, this may need be injected less than once a week. Syncria’s point of difference from Novo Nordisk’s and Lilly’s analogues is that it fuses human GLP-1 to human albumin.

Victoza is recommended for approval in combination with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea.

It can also be given with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

Professor Steve Gough at Birmingham’s Selly Oak Hospital, said: “There is no doubt that there is a great unmet need for a treatment with Victoza’s benefits and physicians in the UK are very encouraged by [the] data.”

As well as a New Drug Application (NDA) to the FDA and marketing authorisation application to the European Medicines Agency, Novo Nordisk has also submitted an NDA in Japan last year. A decision on that is expected in 2010.