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.
Contacts for further information
Media: Investors:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 4442 3573 Tel: (+45) 4443 7919
mike@novonordisk.com mlau@novonordisk.com
Kasper Roseeuw Poulsen
Tel: (+45) 4442 4471
krop@novonordisk.com
In North America: In North America:
An Phan Hans Rommer
Tel: (+1) 609 558 0420 Tel: (+1) 609 919 7937
anph@novonordisk.com hrmm@novonordisk.com
Company Announcement no 23 / 2009
