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2016-01-28

Swedish Orphan Biovitrum AB (publ): Sobi to present new interim ASPIRE data at EAHAD congress suggesting that patients can reduce bleeding rates with long-term

New interim results from ASPIRE, the ongoing long-term extension study of
Elocta® (efmoroctocog alfa), marketed by Biogen as Eloctate® (Antihemophilic
Factor (Recombinant), Fc Fusion Protein) in the United States, suggest that
patients can maintain prolonged protection against bleeding episodes at
extended prophylactic dosing intervals. The data will be presented bySwedish
Orphan Biovitrum AB (publ)(Sobi) (STO: SOBI) andBiogen(NASDAQ: BIIB) at the
9th Annual Congress of the European Association for Haemophilia and Allied
Disorders (EAHAD), taking place in Malmö, Sweden, 3-5 February, 2016.

In total 13 posters will be presented by the two companies, including results
from a European retrospective study of the current treatment practices of
haemophilia A and B which emphasises the need for additional innovation in
haemophilia. Further data will be presented that show how Elocta may improve
joint health in people with haemophilia A.

"The interim data from our long-term Elocta extension study, ASPIRE, show that
the overall annualised bleeding rates were maintained or even further reduced
with long-term prophylactic treatment compared to the rates seen in the
pivotal studies", said Dr Krassimir Mitchev, MD, PhD, Vice President, Medical
Therapeutic Area Head Haemophilia at Sobi. "In addition, the results of our
European observational retrospective study show that people with haemophilia
on conventional prophylactic treatment still experience breakthrough bleeds.
The results suggest that there is an opportunity for further improvement of
the treatment of haemophilia."

ASPIRE is an ongoing open-label, non-randomised, multi-year extension study
for people who completed the pivotal, phase 3 A-LONG or Kids A-LONG studies.
A-LONG and Kids A-LONG demonstrated the efficacy, safety and pharmacokinetics
of Elocta in previously treated males 12 years of age and older, and children
less than 12 years old, respectively, with severe haemophilia A.

Dr Mitchev continued: "These interim results from ASPIRE highlight the value
of extended half-life therapy in managing bleeds and further support the
safety and efficacy profile of Elocta, the first meaningful treatment advance
for people with haemophilia A in the EU in nearly 20 years. The data adds to
the body of robust clinical data for Elocta over the longest clinical
observation period of any extended half-life therapy to date."

The titles of the poster presentations are as follows:

Haemophilia overall:

* Adherence to treatment in haemophilia: a comparison of conventional and
prolonged half-life therapies;P115
* A European Retrospective Study of the Current Treatment Practice of
Haemophilia A;P059
* A European Retrospective Study of the Current Treatment Practice of
Haemophilia B;P062

Elocta®/Eloctate® (rFVIIIFc):

* Long-Term Safety and Efficacy of Recombinant Factor VIII Fc Fusion Protein
(rFVIIIFc) in Adults and Adolescents with Severe Haemophilia A: An Updated
Interim Analysis of the ASPIRE Study;P070
* Second Interim Analysis of the ASPIRE Study Evaluating Long-Term Safety and
Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in
Children with Severe Haemophilia A;P072
* Modified Haemophilia Joint Health Scores (mHJHS) Outcomes With Recombinant
Factor VIII Fc Fusion Protein (rFVIIIFc) Prophylaxis in Subjects With
Severe Haemophilia A;P075
* Long-Term Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc)
Prophylaxis in Paediatric, Adolescent, and Adult Subjects with Target
Joints and Severe Haemophilia A;P003
* Low Bleeding Rates With Increase or Maintenance of Physical Activity in
Patients Treated With Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc)
in the A-LONG and Kids A-LONG Studies;P002
* The cost-effectiveness of rFVIIIFc in a Swedish setting;P086

Alprolix® (rFIXFc):

* Effect of Sampling Duration on Pharmacokinetic (PK) Parameters of
Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-LONG
Study;P040
* Extended-Interval Prophylaxis With Recombinant Factor IX Fc Fusion Protein
(rFIXFc) in Adults/Adolescents With Haemophilia B: Interim Results of the
B-YOND Extension Study;P044
* Clinical Outcomes in Children With Haemophilia B Treated Long Term With
Recombinant Factor IX Fc Fusion Protein (rFIXFc) Prophylaxis: Interim
Results of the B-YOND Extension Study;P045
* Low Bleeding Rates With Increase or Maintenance of Physical Activity in
Patients Treated With Recombinant Factor IX Fc Fusion Protein (rFIXFc) in
the B-LONG and Kids B-LONG Studies;P001

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About Elocta®

Elocta (efmoroctocog alfa) is the first recombinant clotting factor VIII
therapy in the EU that offers an extended half-life in the body. It is
indicated for the treatment and prophylaxis of bleeding episodes in patients
with haemophilia A (factor VIII deficiency) and can be used by people of all
ages. It is also known as Eloctate® (Antihemophilic Factor (Recombinant), Fc
Fusion Protein) in Australia, Canada, Japan, New Zealand and the U.S., where
it is approved for the treatment of haemophilia A.

Elocta was developed by fusing B-domain deleted factor VIII to the Fc portion
of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the
body). This enables Elocta to utilise a naturally occurring pathway to
prolong the time the therapy remains in the body. While Fc fusion technology
has been used in other therapies for more than 15 years, Sobi and Biogen are
the first companies to utilise it in the treatment of haemophilia. As with
any infused protein, allergic type hypersensitivity reactions and development
of inhibitors may occur following administration of Elocta. For full
prescribing information visitwww.elocta.com.

About haemophilia A and B

Haemophilia is a rare, genetic disorder in which the ability of a person's
blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male
births annually, and more rarely in females. Haemophilia B occurs in about
one in 25,000 male births annually, and more rarely in females. Worldwide, it
is estimated that more than 400,000 people are living with haemophilia.
Haemophilia A is caused by having substantially reduced or no factor VIII
activity, while haemophilia B is caused by having substantially reduced or no
factor IX activity; factor VIII and factor IX are needed for normal blood
clotting.

People with haemophilia A or B experience prolonged bleeding episodes that can
cause pain, irreversible joint damage and life-threatening haemorrhages.
Prophylactic infusions of factor VIII or IX can temporarily replace the
missing clotting factors that are needed to control bleeding and prevent new
bleeding episodes.[i]The World Federation of Hemophilia recommends that
prophylaxis be the goal of therapy because it may prevent bleeding and joint
destruction. As a result, regular prophylactic treatment may slow progression
of joint disease and may improve quality of life.[ii]

About the Biogen/Sobi collaboration

Sobi and Biogen are collaboration partners in the development and
commercialisation of Elocta for haemophilia A, which is also known as
Eloctate® (Antihemophilic Factor (Recombinant), Fc Fusion Protein) in
Australia, Canada, Japan, New Zealand and the U.S., where it is approved for
the treatment of haemophilia A. Sobi holds final development and
commercialisation rights in pre-specified territories, which include Europe,
North Africa, Russia and certain countries in the Middle East. Biogen leads
development and manufacturing of the product and holds commercialisation
rights in North America and all other regions in the world outside of the
Sobi territory.

About Sobi

Sobi is an international specialty healthcare company dedicated to rare
diseases. Sobi's mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets
a portfolio of specialty and rare disease products for partner companies
across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion
(USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on
NASDAQ OMX Stockholm. More information is available at www.sobi.com.

For more information please contact

----------------------------------------------------------------------------------------------------
| Media relations Investor relations |
| Oskar Bosson, Head of Communications Jörgen Winroth, Vice President, Head of Investor Relations |
|+46 70 410 71 80 +1 347-224-0819, +1 212-579-0506, +46 8 697 2135 |
| oskar.bosson@sobi.com jorgen.winroth@sobi.com |
| |
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---------------------------------------[i]Hemophilia Federation of America. What is Hemophilia? Available
at:http://www.hemophiliafed.org/bleeding-disorders/hemophilia/treatment/.
Accessed: November 15
[ii]Guideline for the management of hemophilia, World Federation of
Hemophilia, 2nd edition,http://www1.wfh.org/publication/files/pdf-1472.pdf.
Accessed: December 2015

005e_EAHAD
http://hugin.info/134557/R/1981778/726114.pdf

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Globenewswire

HUG#1981778

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