Lars Rebien Sørensen, president and chief executive officer of Novo Nordisk, said: "Our development programme for NN622 continues unaffected by Novartis' decision. Initiation of the Phase 3 programme is progressing according to schedule and as announced on 7 September we expect these studies to start later this year. Results from our Phase 2 studies confirmed that the profile of NN622 meets the therapeutic objectives we had set. In terms of commercialisation of the product in North America we will now be considering various alternatives."
In the Phase 2 studies the doses selected for further development demonstrated a significant lowering of HbA1c (a marker for glucose levels in the blood) in the range of 1-1.5%-points and of fasting plasma glucose in the range of 3-4.5 mmol/L with a simultaneous significant improvement of insulin sensitivity. In addition, NN622 showed an attractive action profile on lipids, with a significant increase in HDL-cholesterol of 18-30% and a substantial decrease in the levels of triglycerides and free fatty acids.
A very wide range of doses have been evaluated in the clinical proof of concept studies, and the already known PPAR agonist side effects have been reported with a clear dose-response relationship. This has allowed Novo Nordisk to select doses for the upcoming clinical Phase 3 studies, with a positive benefit/risk ratio.
The discontinuation of the agreement will not impact Novo Nordisk's expectations for the financial results for 2001.
Type 2 diabetes is known to be a multi-factorial disease requiring treatment of among others hyperglycaemia, insulin resistance, hypertriglyceridaemia, and low HDL-cholesterol.
NN622 is a PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist, which in preclinical, in early clinical trials and in clinical proof of concept studies has shown potential to regulate both blood glucose and diabetic dyslipidaemia. The compound, in-licensed by Novo Nordisk from Dr Reddy's Laboratories, is chemically and pharmacologically different from presently marketed PPAR agonists and is a member of a new class of insulin sensitisers.
Phone conference
At 11:00 am CET today, a conference call will be held. Investors will be able to listen in via a link on www.novonordisk.com, which can be found under 'Investors - Conference call'. Presentation material for the conference call will be made available approximately half an hour before on the same page.
Forward-looking statement
In the Phase 2 studies the doses selected for further development demonstrated a significant lowering of HbA1c (a marker for glucose levels in the blood) in the range of 1-1.5%-points and of fasting plasma glucose in the range of 3-4.5 mmol/L with a simultaneous significant improvement of insulin sensitivity. In addition, NN622 showed an attractive action profile on lipids, with a significant increase in HDL-cholesterol of 18-30% and a substantial decrease in the levels of triglycerides and free fatty acids.
A very wide range of doses have been evaluated in the clinical proof of concept studies, and the already known PPAR agonist side effects have been reported with a clear dose-response relationship. This has allowed Novo Nordisk to select doses for the upcoming clinical Phase 3 studies, with a positive benefit/risk ratio.
The discontinuation of the agreement will not impact Novo Nordisk's expectations for the financial results for 2001.
Type 2 diabetes is known to be a multi-factorial disease requiring treatment of among others hyperglycaemia, insulin resistance, hypertriglyceridaemia, and low HDL-cholesterol.
NN622 is a PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist, which in preclinical, in early clinical trials and in clinical proof of concept studies has shown potential to regulate both blood glucose and diabetic dyslipidaemia. The compound, in-licensed by Novo Nordisk from Dr Reddy's Laboratories, is chemically and pharmacologically different from presently marketed PPAR agonists and is a member of a new class of insulin sensitisers.
Phone conference
At 11:00 am CET today, a conference call will be held. Investors will be able to listen in via a link on www.novonordisk.com, which can be found under 'Investors - Conference call'. Presentation material for the conference call will be made available approximately half an hour before on the same page.
Forward-looking statement
The above sections contain forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995.
Such forward-looking statements are subject to risk and uncertainties that may cause actual results to differ materially from expectations, including unexpected developments in the international currency exchange and securities markets, delay or failure of development projects, production problems, government-mandated or market-driven price decreases for Novo Nordisk's products in the company's major markets and the introduction of competing products within Novo Nordisk's core businesses.
These and other risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 27 April 2001.
Novo Nordisk is under no duty to update any of the forward-looking statements after the date of this report or to confirm such statements to actual results, unless required by law.
Novo Nordisk (NYSE:NVO) is a focused healthcare company and world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as coagulation disorders, growth disorders 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 15,000 people in 68 countries and markets its products in 179 countries. For further company information visit www.novonordisk.com.
Such forward-looking statements are subject to risk and uncertainties that may cause actual results to differ materially from expectations, including unexpected developments in the international currency exchange and securities markets, delay or failure of development projects, production problems, government-mandated or market-driven price decreases for Novo Nordisk's products in the company's major markets and the introduction of competing products within Novo Nordisk's core businesses.
These and other risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 27 April 2001.
Novo Nordisk is under no duty to update any of the forward-looking statements after the date of this report or to confirm such statements to actual results, unless required by law.
Novo Nordisk (NYSE:NVO) is a focused healthcare company and world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as coagulation disorders, growth disorders 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 15,000 people in 68 countries and markets its products in 179 countries. For further company information visit www.novonordisk.com.
For further information please contact:
Media:
Outside North America:
Elin K Hansen
Phone (direct): (+45) 4442 3450
Outside North America:
Elin K Hansen
Phone (direct): (+45) 4442 3450
In North America:
Susan Jackson
Phone (direct): (+1) 609 919 7776
Susan Jackson
Phone (direct): (+1) 609 919 7776
Investors:
Outside North America:
Peter Haahr
Phone (direct): (+45) 4442 1207
Outside North America:
Peter Haahr
Phone (direct): (+45) 4442 1207
Palle Holm Olesen
Phone (direct): (+45) 4442 6175
Phone (direct): (+45) 4442 6175
In North America
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Stock Exchange Announcement No 19 / 2001