UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
September 4, 2012
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NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
Novo Allé
DK- 2880, Bagsvaerd
Denmark
(Address of principal executive offices)
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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
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 passed the review by the First Committee on Drugs of Japan’s Pharmaceutical Affairs. The remaining step in the regulatory process will now be an official approval from the Ministry of Health, Labour and Welfare (MHLW).
The First Committee on Drugs of Pharmaceutical Affairs serves as an advisory body to the MHLW, related to pharmaceuticals including new drug applications. The passing of the review by the drug committee is a critical milestone in the Japanese review process prior to a marketing authorisation from the MHLW.
“We are very excited about the result of the review of insulin degludec,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “This is a significant milestone towards what may be the first approval of insulin degludec, an insulin with potential to fulfil unmet medical needs for millions of people with diabetes who require insulin.”
Novo Nordisk expects to receive marketing authorisation from the MHLW within a few months and that insulin degludec will be launched shortly after completion of the subsequent price negotiations.
About insulin degludec
Insulin degludec is a once-daily, ultra-long-acting basal insulin analogue discovered and developed by Novo Nordisk. Insulin degludec has a distinct slow absorption which provides a flat and stable action profile. Insulin degludec has been studied in a large-scale clinical trial programme, BEGIN™, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust insulin degludec dosing time to suit patient needs.
Company Announcement No 54/ 2012 |
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Novo Nordisk A/S |
Novo Allé |
Telephone: |
Internet: |
CVR no: |
Investor Relations |
2880 Bagsværd |
+45 4444 8888 |
novonordisk.com |
24256790 |
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Denmark |
Telefax: |
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+45 4444 6626 |
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Insulin degludec was submitted for regulatory approval to the Japanese Ministry of Health, Labour and Welfare (MHLW) in December 2011 and to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in September 2011. In addition, applications have been submitted for regulatory approval in Canada, Switzerland and a range of 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. Headquartered 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 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: |
Mike Rulis |
Kasper Roseeuw Poulsen |
Tel: (+45) 3079 3573 |
Tel: (+45) 4442 4303 |
mike@novonordisk.com |
krop@novonordisk.com |
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Frank Daniel Mersebach |
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Tel: (+45) 4442 0604 |
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fdni@novonordisk.com |
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Lars Borup Jacobsen |
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Tel: (+45) 3075 3479 |
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lbpj@novonordisk.com |
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In North America: |
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Ken Inchausti |
Jannick Lindegaard |
Tel: (+1) 609 514 8316 |
Tel: (+1) 609 786 4575 |
kiau@novonordisk.com |
jlis@novonordisk.com |
Company Announcement No 54/ 2012 |
Page 2 of 2 | |||
Novo Nordisk A/S |
Novo Allé |
Telephone: |
Internet: |
CVR no: |
Investor Relations |
2880 Bagsværd |
+45 4444 8888 |
novonordisk.com |
24256790 |
|
Denmark |
Telefax: |
|
|
|
|
+45 4444 6626 |
|
|
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 |