Novo Nordisk A/S - Research Update; Victoza(R) Recommended Marketing Authorisation for Treatment of Type 2 Diabetes

April 23, 2009 |

3 min read

BAGSVÆRD, DENMARK--(Marketwire - April 23, 2009) - Novo Nordisk receives positive opinion on Victoza® (liraglutide) from the European regulatory authorities

Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMEA) adopted a positive opinion, recommending marketing authorisation, for Victoza® for treatment of type 2 diabetes.

Victoza® is the brand name for liraglutide, the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. The positive opinion for Victoza® 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.

Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months. Subject to the Commission’s approval, Novo Nordisk expects to launch Victoza® in a number of European markets during this summer.

“We are very pleased with the positive opinion from the CHMP, which gives us confidence that Victoza® will soon become available to many people with type 2 diabetes in Europe,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “In clinical studies involving more than 6,500 patients, 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® will offer people with type 2 diabetes a valuable new treatment option.”

The positive opinion from the CHMP does not change Novo Nordisk’s expectations for the company’s financial results for 2009, which were provided on 29 January in connection with the release of the financial results for 2008. Novo Nordisk will provide an update on the expectations for the company’s financial results for 2009 on 30 April 2009 in connection with the release of the financial results for the first quarter of 2009.

About Victoza®

Victoza® is the first once-daily human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes. Victoza® works both by stimulating the release of insulin when glucose levels become too high, and by reducing appetite. 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.

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 27,000 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.

Company Announcement no 23 / 2009

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