NovoEight® provides long-term reduction of bleeding in people with haemophilia A

Copenhagen, Denmark (ots/PRNewswire) -

For healthcare media only, not for US, UK or Spanish journalists

Today, Novo Nordisk announced new phase 3 interim data from its
guardian(TM)2 trial for its recombinant coagulation factor VIII
(rFVIII) product NovoEight(R) (turoctocog alfa), the first new rFVIII
molecule in over a decade, which shows that it provides long-term
reduction from bleeding in people with haemophilia A when used as a
preventative treatment.1 The results were presented at the World
Federation of Haemophilia (WFH) World Congress and support findings
from other studies within the guardian(TM) clinical programme that
found NovoEight(R) demonstrated good efficacy in preventing and
treating bleeds without inhibitor development in previously treated
patients.2,3

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/71400529-novoeight-reduction-of-bleedin
g-haemophilia-a

Commenting on the results, Dr Margareth Ozelo, Hemocentre, IHTC,
University of Campinas, Sao Paulo, Brazil and guardian(TM)2
investigator said, "As a physician treating haemophilia A, having
another FVIII product available is good news and can lead to improved
treatment outcomes and quality of life for our patients. Reducing the
number of bleeding episodes is a key consideration as they are very
painful and frightening for patients and caregivers and can lead to
severe long-term joint damage or arthropathy."

NovoEight(R) has been carefully designed using advanced protein
and purification technology to provide a reliable and portable
treatment option for people with haemophilia A combined with a good
safety profile.4 NovoEight(R) offers convenient and flexible storage
requirements and can be stored at 30 C/86 F for 6 months giving
patients the freedom to administer whenever and wherever needed.5,6

Phase 3 guardian(TM) 2 results:

Guardian(TM)2 is the extension of the pivotal guardian(TM)
clinical programme, one of the largest and most comprehensive
pre-registration clinical trial programmes in haemophilia, with more
than 210 severe haemophilia A patients treated. Guardian(TM)2 is an
open-label, multinational, single-arm extension trial involving 188
haemophilia A patients from 18 countries who had been previously
enrolled in the guardian(TM)1 and guardian(TM)3 trials. Patients
received NovoEight(R) in a preventative regimen and to treat
breakthrough bleeds. Interim results found:1

- The overall estimated annual bleeding rate (ABR) achieved during
preventative regimen with NovoEight(R) was 3.1 (median 1.7) bleeds/patient/year,
ranging from 1.4 (children aged 0-5) to 1.9 for adults (median number of
bleeds/patient/year)
- Preventative regimen with NovoEight(R) led to a decrease in ABR, followed by
stabilisation at a lower level over the time period assessed.

About NovoEight(R) NovoEight(R) has been approved by the FDA
(October 2013) and EMA (November 2013) for the treatment and
prophylaxis of bleeding in patients with haemophilia A. NovoEight(R)
has also been approved in Japan and Australia (January 2014) and in
Switzerland (February 2014) and applications for regulatory approvals
have been submitted in a range of other countries.

Novo Nordisk in Haemophilia

In addition to NovoEight(R), Novo Nordisk has developed a
comprehensive portfolio of molecules aimed at improving haemophilia
treatment. Marketed products include NovoSeven(R)for the treatment of
spontaneous bleeds and for coverage during surgery in patients with
haemophilia and inhibitors (antibodies) against factor VIII (FVIII)
and factor IX (FIX) (haemophilia A and B with inhibitors) and
NovoThirteen(R) for FXIII congenital deficiency, a very rare and
serious bleeding disorder with limited treatment options. Molecules
in the clinical development pipeline include N8-GP, designed to
provide a longer half-life and the potential to reduce the treatment
burden for people with haemophilia A and N9-GP, a long-acting
recombinant factor IX for haemophilia B that has the potential to
significantly reduce bleeding with weekly injections.

About Haemophilia A

Haemophilia is a chronic, inherited bleeding disorder that
primarily affects males. People with haemophilia A are either missing
or have a malfunctioning factor VIII protein, which is essential for
proper blood clotting. People with haemophilia A have a tendency to
bleed longer than most, or to bleed internally into muscles, joints
or organs, because they are missing this clotting factor. To manage
the disease and stop bleeding, people with haemophilia A must replace
the missing factor VIII protein, which is accomplished by intravenous
injection of the clotting factor.

Globally, it is estimated that 420,000 people have haemophilia.7
The disease is severely under-diagnosed in developing countries.

Headquartered in Denmark, Novo Nordisk is a global healthcare
company with 90 years of innovation and leadership in diabetes care.
The company also has leading positions within haemophilia care,
growth hormone therapy and hormone-replacement therapy. Novo Nordisk
employs approximately 40,000 employees in 75 countries, and markets
its products in more than 180 countries. For more information, visit
novonordisk.com [ file:///C:UsersnipDesktopCorporate%20Communicat
ionsnovonordisk.com ].

References

1) Ozelo M. et al. Lowering in annualized bleeding rates over time with
turoctocog alfa prophylaxis: 3-year interim results of the guardian(TM)2 extension
trial. Oral presentation (FP-M-01) at WFH 2014, 12th May 2014.
2) Lentz SR. et al.Results from a large multinational clinical trial
(guardian(TM)1) using prophylactic treatment with turoctocog alfa in adolescent and
adult patients with severe haemophilia A: safety and efficacy. Haemophilia
2013;19(5):691-7.
3) Kulkarni R. et al.Results from a large multinational clinical trial
(guardian(TM)3) using prophylactic treatment with turoctocog alfa in paediatric
patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia
2013;19(5):698-705.
4) Thim et al. Haemophilia 2010;16:349-59.
5) Viuff et al. Haemophilia 2011;17:695-702.
6) Targeted room temperature storage.
7) Internal calculation, data on file .

Video:
http://www.multivu.com/mnr/71400529-novoeight-reduction-of-bleeding-haemophilia-a

ots Originaltext: Novo Nordisk A/S
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Contact:
Further information: Media: Katrine Sperling, +45 3079 6718,
krsp@novonordisk.com; Ken Inchausti (US), +1 609 514 8316,
kiau@novonordisk.com; Investors: Kasper Roseeuw Poulsen, +45 3079
4303,
krop@novonordisk.com; Jannick Lindegaard Denholt, +45 3079 8519,
jlis@novonordisk.com; Lars Borup Jacobsen, +45 3075 3479,
lbpj@novonordisk.com; Daniel Bohsen, +45 3079 6376
dabo@novonordisk.com;
Frank Daniel Mersebach (US), +1 609 235 8567, fdni@novonordisk.com