NovoEight(R) Maintains Potency When Stored at 40 Degrees Centigrade Offering People With Haemophilia A Increased Flexibility in Their Daily Lives

PR73635

GLASGOW, Scotland, May 21, 2018, /PRNewswire=KYODO JBN/--

A new long term stability study has shown that haemophilia A treatment

NovoEight(R) (turoctocog alfa) remains potent after three months exposure to

temperatures of 40 Degrees Centigrade.[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(R) up to 40 Degrees Centigrade 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(R) 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(R) allows for it to be kept at

temperatures of up to 40 degrees centigrade for three months.[3]

About the study

This was a long-term stability study comparing the potency of NovoEight(R)

stored at 5 Degrees Centigrade for 30 months to NovoEight(R) stored at 5

Degrees Centigrade for 27 months, then followed by storage at 40 Degrees

Centigrade ±2 Degrees Centigrade/75% relative humidity (RH) ±5% RH for three

months. The potency of NovoEight(R) was maintained at high storage temperature

and humidity conditions.

The effect of repeated temperature changes was tested by storage at 5 Degrees

Centigrade ±3 Degrees Centigrade/ambient humidity/darkness for 24 months,

followed by cycling between 5 Degrees Centigrade and 40 Degrees Centigrade/75%

RH up to 10 times; the product was then stored at 40 Degrees Centigrade/75% RH

for three months (resulting in a total of four months at 40 Degrees

Centigrade), and returned to 5 Degrees Centigrade to attain 30 months shelf

life.[1]

The potency of NovoEight(R) was maintained at high storage temperature and

humidity conditions. Up to 10 cycles of temperature changes and storage at 40

Degrees Centigrade did not affect potency.[1]

About NovoEight(R)

NovoEight(R) 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 Degrees Centigrade 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(R) 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

Asa 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 Kjaer

+45-3079-3009

cnje@novonordisk.com

Source: Novo Nordisk