Report of Foreign Issuer (6-k)
27 August 2015 - 1:01AM
Edgar (US Regulatory)
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
August 26, 2015
________________
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.
If “Yes” is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g-32(b):82-________
Novo Nordisk to initiate phase 3a development of oral semaglutide, a once-daily oral GLP-1 analogue
Bagsværd, Denmark, 26 August 2015 - Novo Nordisk today announced
the decision to initiate a phase 3a programme with oral semaglutide; a once-daily oral formulation of the long-acting GLP-1 analogue
semaglutide. The decision follows the encouraging results of the proof–of-concept phase 2 trial announced on 20 February
2015 and the subsequent consultations with regulatory authorities.
Novo Nordisk intends to initiate a global phase 3a programme, named PIONEER,
comprising seven trials with approximately 8,000 people with type 2 diabetes. The PIONEER programme will include six safety and
efficacy trials and one trial for evaluating the cardio-vascular safety of oral semaglutide. The first trial in the programme is
planned for initiation in first quarter of 2016 and will investigate the efficacy and safety of once- daily oral semaglutide doses
of 3 mg, 7 mg and 14 mg, compared to once-daily oral anti- diabetic sitagliptin dose of 100 mg. The remaining six trials of the
PIONEER programme are all expected to be initiated during 2016.
In order to meet capacity requirements for current and future diabetes
care products, including oral semaglutide, Novo Nordisk expects to invest an estimated 2 billion US dollars over the coming five
years in two new production facilities; a new production facility for a range of active pharmaceutical ingredients in Clayton,
North Carolina, US and a new drug-product facility in Måløv, Denmark. The final design and cost of the new production
facilities will be presented for approval by the company’s board of directors in 2016.
“Delivering protein-based medicine like semaglutide in the form
of a tablet and producing it on a large scale is a major challenge, and with the announcement today we have reached a significant
milestone towards achieving that goal”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer
of Novo Nordisk. “We are excited about the opportunities oral semaglutide represents as a new oral anti-diabetic agent to
further improve type 2 diabetes treatment”.
Page 2 of 2
About semaglutide
Semaglutide (NN9924) is a new glucagon-like peptide-1 (GLP-1) analogue
that can help people with type 2 diabetes achieve substantial lowering of blood glucose with a low risk of hypoglycaemia. In addition,
semaglutide induces weight loss by decreasing appetite and food intake. The oral formulation of semaglutide is provided in a tablet
formulation with SNAC, an absorption-enhancing excipient included in the Eligen® Carrier
Concept. The Eligen® technology is licenced from Emisphere Technologies, Inc.
Novo
Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has
given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia,
growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 39,700 people in 75 countries and markets
its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed
on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
Further information
Media: |
Katrine Sperling |
+45 3079 6718 |
krsp@novonordisk.com |
Ken Inchausti (US) |
+1 609 514 8316 |
kiau@novonordisk.com |
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Investors: |
Peter Hugreffe Ankersen |
+45 3075 9085 |
phak@novonordisk.com |
Daniel Bohsen |
+45 3079 6376 |
dabo@novonordisk.com |
Melanie Raouzeos |
+45 3075 3479 |
mrz@novonordisk.com |
Frank Daniel Mersebach (US) |
+1 609 235 8567 |
fdni@novonordisk.com |
Novo Nordisk A/S
Investor Relations |
Novo Allé
2880 Bagsværd
Denmark |
Telephone:
+45 4444 8888
|
Internet:
www.novonordisk.com
CVR no:
24 25 67 90 |
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Company announcement No 52 / 2015 |
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: August 26, 2015 |
NOVO NORDISK A/S
Lars Rebien Sørensen,
Chief Executive Officer |
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