c106018.htm - Prepared by Imprima

 

 

 

 


 

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION


Washington, D.C. 20549
 

________________

FORM 6-K

________________

 

REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934

December 28, 2011

________________

 

        NOVO NORDISK A/S        
(Exact name of Registrant as specified in its charter)

Novo Allé
DK- 2880, Bagsvaerd
Denmark

(Address of principal executive offices)

________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

Form 20-F [X]     

     Form 40-F [  ]

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes [  ]     

      No [X]

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g-32(b):82-_____________________

 

 

 


 

 

Company Announcement

22 December 2011

Novo Nordisk files for regulatory approval of the ultra-long-acting insulin Degludec in Japan 

 

Novo Nordisk today announced the submission to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, of a new drug application for the approval of ultra-long-acting insulin Degludec. This new-generation basal insulin has been developed for the treatment of people with type 1 and type 2 diabetes.

 

“We are very excited about being able to file for regulatory approval of Degludec in Japan,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “This new-generation basal insulin has the potential to fulfil unmet medical needs for millions of people with diabetes who require insulin.”   

 

The Japanese filing is based on results from the BEGIN™ clinical trial programme which involved nearly 7,000 type 1 and type 2 diabetes patients and included Japan in several trials. Data from the trials have shown Degludec to effectively lower blood glucose levels, while also demonstrating a significantly lower rate of hypoglycaemia relative to insulin glargine, especially during the night. 

 

The submission in Japan of a new drug application for DegludecPlus, an insulin formulation containing the ultra-long-acting basal insulin Degludec and the fast-acting insulin NovoRapid®, is expected to take place in the first half of 2012.This will allow for inclusion of clinical data from the recently concluded trial testing DegludecPlus versus insulin glargine both administered once daily as announced on 7 November 2011 – in addition to the data from other trials in the BOOST™ programme involving in total more than 3,000 type 1 and type 2 patients.    

  

  

         

Company Announcement no 80 / 2011

Page 1 of 2

 

Novo Nordisk A/S

Investor Relations

Novo Allé

2880 Bagsværd

Denmark

Telephone:

+45 4444 8888

Telefax:

+45 4444 6626

Internet:

novonordisk.com

CVR no:

24256790

 

 


 

 

About Degludec and DegludecPlus

 

Degludec (insulin degludec) is an ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. It forms multi-hexamers upon subcutaneous injection, resulting in a soluble depot from which Degludec is slowly and continuously absorbed into the circulation, contributing to effective lowering of fasting glucose and minimal blood glucose variations.  

  

DegludecPlus (insulin degludec/insulin aspart) contains the ultra-long-acting basal insulin Degludec in a formulation with a bolus boost of insulin aspart. DegludecPlus is the first and only soluble insulin combination of ultra-long-acting insulin degludec and the most prescribed rapid acting insulin, NovoRapid®, providing both fasting and post-prandial glucose control. 

 

BEGIN™ and BOOST™ programmes

Novo Nordisk has now completed the phase 3a programmes, BEGIN™ and BOOST™. The results from these studies comprise the majority of the data supporting the regulatory applications for Degludec and DegludecPlus, respectively. BEGIN™ and BOOST™ were the largest clinical trial programmes in the history of Novo Nordisk and in the field of insulin therapy, with nearly 10,000 type 1 and type 2 diabetes patients. The programmes were designed after consultancy with the regulatory agencies in the USA, Europe and Japan.

 

Novo Nordisk is a global healthcare company with 88 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 32,500 employees in 74 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com.  

 

 

Media:

Investors:

 

 

Katrine Sperling

Klaus Bülow Davidsen

 

Tel: (+45) 4442 6718

Tel: (+45) 4442 3176

 

krsp@novonordisk.com  

klda@novonordisk.com  

 

 

Frank Daniel Mersebach

 

Tel: (+45) 4442 0604

 

fdni@novonordisk.com  

 

 

Lars Borup Jacobsen

 

Tel: (+45) 3075 3479

 

lbpj@novonordisk.com

 

 

In North America:

 

 

Ken Inchausti

Jannick Lindegaard

 

Tel: (+1) 609 514 8316

Tel: (+1) 609 786 4575

 

kiau@novonordisk.com  

jlis@novonordisk.com  

 

 

         

 

Company Announcement no 80 / 2011

Page 2 of 2

 

 

 

Novo Nordisk A/S

Investor Relations

Novo Allé

2880 Bagsværd

Denmark

Telephone:

+45 4444 8888

Telefax:

+45 4444 6626

Internet:

novonordisk.com

CVR no:

24256790

               

 

 


 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.

Date: December 28, 2011

NOVO NORDISK A/S

Lars Rebien Sørensen,

President and Chief Executive Officer