c105599.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

September 30, 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

2 September 2011 

 

NovNordisk files for regulatory approval of the ultra-long-acting insulinDegludeand DegludecPlus in the US

 

 

Novo Nordisk  toda announced the submission to the US Foo and  Drug Administration  of  tw new  drug  applications  for  the approva of  ultra-long- acting insuli Degludec and  th insuli combination  analogue DegludecPlus, respectively This new generation of insulins  ha bee developed  for  the treatment  of  people with type 1 an type 2 diabetes. 

 

“We are very  excited about  being  able to file for  the approva of  Degludec and DegludecPlus  now  also i the US,”  sai Mads Krogsgaar Thomsen,  executive vice president  and  chief  science officer of Novo Nordisk “Thi i another significan milestone for Novo Nordisk  and  for  the millions of people with diabetes who requir insulin.” 

 

As for  the Europea applications submitted on 2 September 2011 the US filings are based  on  results  from  the BEGIN™ and  BOOST™ clinica trial programmes which  involved nearly 10,00 type 1 and  type 2 diabetes patients. Dat from  the trials have shown  Degludec to effectively lower  blood  glucose levels,  while consistently  demonstrating  significantly lower  rate of hypoglycaemi relative to insuli glargine,  especiall during th night The trials also showed  tha Degludec ca be administered once daily  a an time of the da with  the possibilit to  change injection  tim from  da to  da according  to the needs of the individua patient, without compromising  glycaemic contro or safety

 

Novo Nordisk  intend to  make both  insulins availabl i the FlexTouc®  prefilled delivery device,  the first insulin pen  tha can deliver up to  160 insuli unit i a singl injection.  The FlexTouch ®  device was first  approved  i Europe earlier this year  and  the technolog has bee used  i the US with  other Novo Nordisk products  since 2010   

         

Company Announcement no 61 / 2011

Page 1 of 3

 

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  an DegludecPlu

 

Degludec  (insulin degludec is a ultra-long-acting  basa insuli analogue discovered  and  developed  b Novo Nordisk.  It forms multi-hexamers upon subcutaneous injection,  resultin i soluble depot  from  which  Degludec  is slowl and continuously absorbed  into the circulation contributin to effective lowering  of  fastin glucose and minima blood  glucose variations. 

 

DegludecPlus (insulin degludec/insulin aspart contains  the ultra-long- acting basa insulin Degludec  i formulation with  bolus  boost  of  insulin aspart.  DegludecPlus  is the first  and  onl solubl insuli combination of ultra- long-acting insuli degludec and the most prescribed  rapid actin insulin, NovoRapi®, providin both  fasting  and post-prandia glucose  control

 

BEGIN™ an BOOST™ programmes 

Novo Nordisk  completed  the phase 3 programmes,  BEGINand  BOOST™  i

2010. The results  fro these studies  comprise the majority  of  the data supporting the regulator applications for  Degludec and  DegludecPlus, respectively BEGINand  BOOSTwere the  largest clinica tria programmes i the histor of  Novo Nordisk  and  i the field of insuli therapy, with nearly 10,00 type  and  type 2 diabetes patients. The programmes were designed after  consultancy  with the regulatory agencies i the USA and  Europe

 

 

 

 

Nov Nordisk  i global  healthcare  compan wit 8 years  o innovatio an leadershi in diabete care.  Th compan also has  leadin position withi haemophili care,  growt hormone therapy  an hormon replacemen therapy.  Headquartere i Denmark Nov Nordisk  employs approximatel 32,00 employee i 7 countries,  an market it product i 17 countries. 

Novo Nordisks B shares  ar liste o NASDAQ  OM Copenhage (Novo-B).  It ADRs  are  liste on th New  York  Stock  Exchang (NVO).  Fo more  information visi   novonordisk.com

  

 

 

 

 

 

 

 

 

 

 

 

         

Company Announcement no 61 / 2011

Page 2 of 3

 

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

 

 


 

 

Further information:

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:

 

Ambre Morley

Jannick Lindegaard

Tel: (+1) 609 216 5240

Tel: (+1) 609 786 4575

ambo@novonordisk.com

jlis@novonordisk.com

 

 

 

 

 

 

 

 

 

 

 

         

Company Announcement no 61 / 2011

Page 3 of 3

 

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: September 30, 2011

NOVO NORDISK A/S

Lars Rebien Sørensen,

President and Chief Executive Officer