NovoEight® Maintains Potency When Stored at 40ºC Offering People With Haemophilia A Increased Flexibility in Their Daily Lives

Glasgow, Scotland (ots/PRNewswire) -

A new long term stability study has shown that haemophilia A
treatment NovoEight® (turoctocog alfa) remains potent after three
months exposure to temperatures of 40ºC.[1] The results were
presented today at the WFH 2018 World Congress in Glasgow, UK.

Treatment storage issues, especially the need for refrigeration,
have been shown to be a common problem reported by people with
haemophilia A.[2] A portability study recently published in Patient
Preference and Adherence found that most people are restricted in
their personal activities, particularly travel and sports, due to
temperature storage issues.[2]If efficacy and safety are unaffected,
storage flexibility was shown to be a strong driver of product
choice.[2]

"Establishing the stability of NovoEight® up to 40°C is part of
our commitment to helping people with haemophilia A to reduce the
burden that this condition places on their lives," said Mads
Krogsgaard Thomsen, ?executive vice president and chief science
officer, Novo Nordisk. "The recent data demonstrate the reliable
nature of NovoEight® as a portable and convenient treatment option,
which could help patients enjoy their daily lives without concern
about the storage of their treatment."

The storage conditions for NovoEight® allows for it to be kept at
temperatures of up to 40ºC for three months.[3]

About the study

This was a long-term stability study comparing the potency of
NovoEight® stored at 5ºC for 30 months to NovoEight® stored at 5ºC
for 27 months, then followed by storage at 40°C ±2°C/75% relative
humidity (RH) ±5% RH for three months. The potency of NovoEight® was
maintained at high storage temperature and humidity conditions.

The effect of repeated temperature changes was tested by storage
at 5°C ±3°C/ambient humidity/darkness for 24 months, followed by
cycling between 5°C and 40°C/75% RH up to 10 times; the product was
then stored at 40°C/75% RH for three months (resulting in a total of
four months at 40°C), and returned to 5°C to attain 30 months shelf
life.[1]

The potency of NovoEight® was maintained at high storage
temperature and humidity conditions. Up to 10 cycles of temperature
changes and storage at 40°C did not affect potency.[1]

About NovoEight®

NovoEight® is a B-domain truncated recombinant human coagulation
factor VIII for the treatment and prevention of bleeding in patients
with haemophilia A.[3]

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 needed for
proper blood clotting. People with haemophilia A have a tendency to
bleed longer than most or to bleed internally into joints, muscles 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.[4]

Globally, it is estimated that 150,000 people have been diagnosed
with haemophilia A.[5] The disease is severely underdiagnosed in
developing countries.

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. Turoctocog alfa is stable during storage at 40°C and multiple
sequences of temperature cycling, poster #52. Presented at the WFH
2018 World Congress, Glasgow, UK, 21 May 2018.

2. Tischer B, Marino R, Napolitano M. Patient preferences in the
treatment of hemophilia A: impact of storage conditions on product
choice. Patient Preference and Adherence. 2018;12:431-441

3. NovoEight® Summary of Product Characteristics, April 2018

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

5. World Federation of Hemophilia. Report on the Annual Global Survey
2016. Published October 2017. Available online at:
http://www1.wfh.org/publications/files/pdf-1690.pdf . Last accessed
April 2018.

Further information

Media:

Katrine Sperling

+45-4442-6718

krsp@novonordisk.com

Åsa Josefsson

+45-3079-7078

aajf@novonordisk.com

Investors:

Peter Hugreffe Ankersen

+45-3075-9085

phak@novonordisk.com

Anders Mikkelsen

+45-3079-4461

armk@novonordisk.com

Christina Kjær

+45-3079-3009

cnje@novonordisk.com

ots Originaltext: Novo Nordisk A/S
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