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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 4, 2012

________________

 

        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-_____________________

 

 

 


 

 

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 Company Announcement

31 August  2012 

 

Insulin degludec passed the review by the First

Committee on Drugs of Pharmaceutical Affairs in Japan

 

 

Novo Nordisk  today  announced  that  insulin  degludec  has  passe the  revie by the First  Committee  on  Drug o Japan’s  Pharmaceutical  Affairs.  The  remaining step in  the  regulator process  will  now  b an  official  approval  from  the  Ministry of Health,  Labour  an Welfare  (MHLW). 

 

The First  Committee  on  Drug o Pharmaceutica Affairs  serves  as  an  advisory body to  th MHLW,  related  to  pharmaceutical including  new  drug  applications. The passin of  the  review  by  th drug  committee  is  critica milestone  i the Japanese review  process  prior  to  a marketing authorisation  fro the  MHLW. 

 

“We are  very  excited  about  the  result  o th review  of  insulin  degludec,”  said Mads Krogsgaard  Thomsen,  executive  vice  presiden and  chief  science  office of Novo Nordisk.  “This  i a significant  milestone  towards  wha may  be  the  first approval  o insulin  degludec,  an  insulin  wit potential  to  fulfil  unmet  medical needs fo millions  o people  with  diabetes  who  require  insulin.” 

 

Novo Nordisk  expects  to  receive  marketin authorisation  from  the  MHLW  within a few  months  an that  insulin  deglude will  be  launched  shortl after   completion  of  the  subsequent  price  negotiations. 

 

About insulin  degludec 

 

Insulin degludec  i once-daily,  ultra-long-actin basal  insulin  analogue discovered and  developed  by  Novo  Nordisk.  Insulin  deglude has  a distinct  slow absorption which  provide a flat and  stable  action  profile.  Insulin  degludec  has been studied  in  a large-scale clinica trial  programme,  BEGIN examinin its impact on  glucose  control,  hypoglycaemia  and  the  possibility  to flexibly adjust insulin degludec  dosing  time  to  suit  patien needs. 

 

 

 

 

Company Announcement No 542012

Page 1 of 2

Novo Nordisk A/S 

Novo Allé 

Telephone: 

Internet: 

CVR no:

Investor Relation

2880 Bagsværd

+45 4444 8888

novonordisk.com 

24256790

 

Denmark

Telefax: 

 

 

 

 

+45 4444 6626

 

 

 

 

 


 

 

Insulin degludec  was  submitted  for  regulatory  approval  to  the  Japanese Ministry o Health,  Labour  an Welfare  (MHLW)  in  December  2011  and  to  the European Medicine Agency  (EMA)  and  th US  Food  and  Dru Administration (FDA) in  September  2011.  I addition,  application have  been  submitted  for regulatory approval  in  Canada,  Switzerlan and  range  o other  countries. 

 

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within  haemophilia  care, growth  hormone  therapy  and hormone replacement therapy Headquartere in  Denmark,  Novo Nordisk employs approximately 

33,300 employees in 75 countries, and markets its products in more than 190 countries. Novo Nordisk’s B shares are liste on NASDA OMX Copenhagen (Novo-B). Its ADRs are listed on th New York Stock Exchange (NVO) For more information visit novonordisk.com. 

 

 

Media:

Investors:

Mike Rulis 

Kasper Roseeuw Poulsen

Tel (+45)  307 357

Tel: (+45) 4442 4303

mike@novonordisk.com

krop@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 542012

Page 2 of 2

Novo Nordisk A/S 

Novo Allé 

Telephone: 

Internet: 

CVR no:

Investor Relation

2880 Bagsværd

+45 4444 8888

novonordisk.com 

24256790

 

Denmark

Telefax: 

 

 

 

 

+45 4444 6626

 

 

 


 

 

 

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 4, 2012

NOVO NORDISK A/S

Lars Rebien Sørensen,

President and Chief Executive Officer