Head-to-Head Trial Shows Refixia® Achieves Greater Total Factor IX Exposure in People With Haemophilia B Than Recombinant Factor IX-Fc Fusion Protein

Glasgow, Scotland (ots/PRNewswire) -

Adults with haemophilia B who received a single dose Refixia®
(nonacog beta pegol; N9-GP) achieved greater total factor IX exposure
than those treated with rFIXFc (recombinant factor IX-Fc fusion
protein). The head-to-head paradigm7 trial also observed a longer
half-life for Refixia®. These pharmacokinetic findings were presented
today at the WFH 2018 World Congress in Glasgow, UK.1

The trial showed that the total factor IX exposure of Refixia® in
patient plasma after injection of a single dose (50 IU/kg) was
4.39-fold greater than for rFIXFc, as measured by the area under the
curve (AUC). Seven days after injection, the factor IX activity in
patients treated with a single dose of Refixia® was six-fold greater
than that of patients treated with rFIXFc at the same dose.

"As a clinician, I know first-hand how challenging it can be to
help people living with haemophilia B reach their treatment goals and
be adequately protected from bleeding" said Dr Carmen Escuriola
Ettingshausen of the Rhein-Main Haemophilia Centre (HZRM), Germany.
"These data will help us better understand the different treatment
options and choose the appropriate treatment for each patient."

The half-life of Refixia® in the trial was 103.2 hours,
significantly longer than the half-life of rFIXFc (84.9 hours). In
addition, total factor IX activity levels 30 mins after infusion were
two-fold greater with Refixia® compared to rFIXFc. No patients
developed inhibitors and no safety concerns were identified during
the trial.

"People with haemophilia B and their clinicians want to be
confident that they are protected from bleeds without worrying" said
Mads Krogsgaard Thomsen, executive vice president and chief science
officer of Novo Nordisk. "These head-to-head data support the strong
clinical profile of Refixia® which can provide an alternative
treatment option for people with haemophilia B with the convenience
of a single weekly dose."

About the paradigm7 trial

Paradigm7 was a multicentre, open-label, randomised, crossover,
pharmacokinetic trial in 15 previously treated adult males with
congenital haemophilia B (factor IX activity <=2%), conducted in
three countries (US, Germany, Switzerland). Patients received single
injections (50 IU/kg) of Refixia® and rFIXFc with >=21 days between
doses. The primary endpoint was dose-normalised area under the factor
IX activity-time curve from 0 to infinity (AUC0-inf,norm).

About Refixia®

Refixia® (nonacog beta pegol; N9-GP) is an extended half-life
factor IX molecule for replacement therapy in patients with
haemophilia B.2 The review of Refixia® was based on the paradigm
clinical programme. In the completed phase 3 trials, 115 previously
treated patients had a total of more than 8,800 exposure days for up
to 2.7 years of treatment with Refixia®.

About haemophilia B

Haemophilia is a chronic, inherited bleeding disorder that
primarily affects males. People with haemophilia B have congenital
factor IX deficiency and are either missing or have a malfunctioning
factor IX protein, which is needed for proper blood clotting.3

Globally it is estimated that 30,000 people have been diagnosed
with haemophilia B. The disease is severely underdiagnosed in some
regions of the world.4

About Novo Nordisk

Novo Nordisk is a global healthcare company with 95 years of
innovation and leadership in diabetes care. This heritage has given
us experience and capabilities that also enable us to help people
defeat obesity, haemophilia, growth disorders and other serious
chronic diseases. Headquartered in Denmark, Novo Nordisk employs
approximately 42,700 people in 79 countries and markets its products
in more than 170 countries. For more information, visit
novonordisk.com (http://www.novonordisk.com), Facebook
(http://www.facebook.com/novonordisk), Twitter
(http://www.twitter.com/novonordisk), LinkedIn
(http://www.linkedin.com/company/novo-nordisk), YouTube
(http://www.Youtube.com/novonordisk).

References

1. Escuriola Ettingshausen C, Hegemann I, Simpson M, et al. A
head-to-head pharmacokinetic comparison of N9-GP and rFIXFc in
patients with haemophilia B. Presented at the WFH 2018 World
Congress, Glasgow, UK, 20-24 May. 2018

2. EMA. Refixia®. Summary of Product Characteristics. Available
at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
ct_Information/human/004178/WC500232816.pdf. Last accessed: April
2018.

3. Srivastava A, Brewer AK, Mauser-Bunschoten EP, et al.
Guidelines for the management of hemophilia. Haemophilia.
2013;19:e1-47

4. National Hemophilia Foundation. Fast Facts. Available at:
http://www.hemophilia.org/About-Us/Fast-Facts. Last accessed: April
2018.

Further Information

Media:

Katrine Sperling [phone] [e-mail]

Åsa Josefsson [phone] [e-mail]



Investors:

Peter Hugreffe Ankersen [phone] [e-mail]

Anders Mikkelsen [phone] [e-mail]

Christina Kjær [phone] [e-mail]


ots Originaltext: Novo Nordisk A/S
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