Report of Foreign Issuer (6-k)
March 17 2020 - 8:07AM
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
March 16, 2020
________________
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 pauses the clinical trials investigating concizumab
(anti-TFPI mAB) in haemophilia A and B with or without inhibitor
Bagsværd, Denmark, 16 March 2020 - Novo
Nordisk today announced that two clinical trials in the concizumab phase 3 programme (explorer7 and 8) and one clinical trial in
the phase 2 programme (explorer5) have been paused. The three clinical trials were investigating concizumab prophylaxis treatment
in haemophilia A and B patients regardless of inhibitor status. Consequently, no additional patients will be recruited, and further
treatment of patients currently enrolled in the trials with concizumab will cease.
The decision is a result of the occurrence of non-fatal
thrombotic events in three patients enrolled in the ongoing phase 3 programme. Novo Nordisk and an independent Data Monitoring
Committee are currently assessing the relevance of the events to the continuation of the programme and no conclusions have yet
been made.
“While it is disappointing to pause the trials, patient safety
is of utmost importance to Novo Nordisk – both for those taking part in our clinical trials and those who use our products
on a daily basis” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Together
with relevant authorities, we will now carefully evaluate all available data and decide how to best move forward”.
About the concizumab phase 2 and 3 programmes
In October 2019, Novo Nordisk initiated the explorer7 phase 3 clinical
trial with concizumab in patients with haemophilia A or B with inhibitors towards FVIII or FIX. The objective of the trial was
to establish the safety and efficacy of once-daily prophylactic subcutaneous concizumab delivered in a pen device to reduce the
number of bleeds. A parallel phase 3 trial in haemophilia A or B patients without inhibitors, explorer8, was initiated in November
2019. The trials were to enrol approximately 293 patients from 32 countries. The explorer5 phase 2 trial was initiated in October
2017 to evaluate the efficacy and safety of once-daily prophylactic subcutaneous concizumab delivered in a pen device to reduce
the number of bleeds of haemophilia A patients. The trial currently includes 15 patients. Approximately 109 patients are currently
being treated with concizumab.
Page 2 of 2
Novo Nordisk is a leading global
healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other
serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs,
expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 42,700 people
in 80 countries and markets its products in around 170 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:
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|
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Mette
Kruse Danielsen
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+45
3079 3883
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mkd@novonordisk.com
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Ken
Inchausti (USA)
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+1
609 240 9429
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kiau@novonordisk.com
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Investors:
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Daniel
Muusmann Bohsen
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+45
3075 2175
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dabo@novonordisk.com
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Valdemar
Borum Svarrer
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+45
3079 0301
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jvls@novonordisk.com
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Ann
Søndermølle Rendbæk
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+45
3075 2253
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arnd@novonordisk.com
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Mark
Joseph Root
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+45
3079 4211
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mjhr@novonordisk.com
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Kristoffer
Due Berg (USA)
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+1
609 235 2989
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krdb@novonordisk.com
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Novo Nordisk A/S
Investor Relations
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Novo Allé
2880 Bagsværd
Denmark
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Telephone:
+45 4444 8888
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Internet:
www.novonordisk.com
CVR no:
24 25 67 90
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Company announcement No 17 / 2020
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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: March 16, 2020
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NOVO NORDISK A/S
Lars Fruergaard Jørgensen
Chief Executive Officer
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