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Swedish Orphan Biovitrum AB (publ): Alprolix® (rFIXFc) approved in the EU for the treatment of haemophilia B

First Fc Fusion therapy approved for haemophilia B in the EU to provide
extended protection against bleeds

Swedish Orphan Biovitrum AB (publ)(Sobi(TM)) (STO: SOBI) andBiogen(NASDAQ:
BIIB) today announced that the European Commission (EC) has approved
Alprolix® (rFIXFc), their extended half-life therapy, for the treatment of
haemophilia B in all 28 European Union (EU) member states and maintained its
orphan designation. Alprolix is the only recombinant factor IX Fc Fusion
protein therapy for haemophilia B to offer people in the EU prolonged
protection against bleeding episodes with fewer prophylactic injections.

Alprolix is indicated for both on-demand and prophylaxis treatment of people
with haemophilia B in all ages. Prophylactically, it can be administered with
an initial dose every seven days or every 10 days with the ability to adjust
the dosing interval based on individual response.

"With the approval of Alprolix, people with haemophilia B in Europe now have
the potential to experience prolonged protection from bleeds with fewer
injections," said Krassimir Mitchev, M.D., Ph.D., vice president and medical
therapeutic area head of Haemophilia at Sobi. "We are working to make
Alprolix available in Europe as quickly as possible. Along with Biogen, we're
excited to continue offering innovative therapies to people with haemophilia
around the world."

The EC's approval of Alprolix was based on results from two global phase 3
clinical trials that demonstrated the efficacy, safety and pharmacokinetics
of Alprolix for haemophilia B: the pivotal B-LONG study for previously
treated adults and adolescents, and the Kids B-LONG study for previously
treated children under age 12. The adverse drug reactions with an incidence
of>0.5 percent for Alprolix were nasopharyngitis (common cold), influenza,
arthralgia (joint pain), upper respiratory tract infection, headache, and
hypertension. The majority of these events were judged as not related or
likely not related to study drug.

"Alprolix has become a meaningful treatment advance for people living with
haemophilia B in countries where it is approved and is backed by robust
clinical data and the longest real-world experience of any prolonged
circulation factor IX therapy to date." said Gilmore O'Neill, M.D., senior
vice president Drug Innovation Units at Biogen. "We're proud to bring the
European haemophilia community one of the first treatment advances in nearly
20 years, and believe the availability of extended half-life therapies in
Europe will change the way that many approach treatment."

Sobi and Biogen collaborate on the development and commercialisation of
Alprolix for haemophilia B. Sobi has final development and commercialisation
rights in the Sobi territory (essentially Europe, North Africa, Russia and
most Middle Eastern markets). Biogen leads development and manufacturing for
Alprolix and has commercialisation rights in North America and all other
regions in the world excluding the Sobi territory.


About Alprolix®

Alprolix® is a recombinant clotting factor therapy developed for haemophilia B
by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1
(a protein commonly found in the body). This technology enables Alprolix to
use a naturally occurring pathway to prolong the time the therapy remains in
the body. While Fc fusion has been used for more than 15 years, Sobi and
Biogen are the first companies to utilise it in the treatment of haemophilia.

Alprolix is currently approved for the treatment of haemophilia B in the
United States, European Union, Canada, Japan, Australia, New Zealand, and
other countries, to provide prolonged protection from bleeds. As with any
infused protein, allergic type hypersensitivity reactions and development of
inhibitors may occur following administration of Alprolix.

About Haemophilia B

Haemophilia B is caused by having substantially reduced or no factor IX
activity, which is needed for normal blood clotting.[1]The World Federation
of Hemophilia estimates that approximately 28,000 people are currently
diagnosed with haemophilia B worldwide.[2]

People with haemophilia B may experience bleeding episodes in joints and
muscles that cause pain, decreased mobility and irreversible joint damage. In
the worst cases, these bleeding episodes can cause organ bleeds and
life-threatening haemorrhages. Infusions of factor IX temporarily replace
clotting factors necessary to resolve bleeding and, when used
prophylactically, to prevent new bleeding episodes.1

About Sobi(TM)

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 across Europe, the Middle
East, North Africa and Russia for partner companies. Sobi is a pioneer in
biotechnology with world-class capabilities in protein biochemistry and
biologics manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion
(USD 385 M) and about 700 employees. The share (STO: SOBI) is listed on
NASDAQ OMX Stockholm. More information is available

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and
delivers worldwide innovative therapies for people living with serious
neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of
the world's oldest independent biotechnology companies and patients worldwide
benefit from its leading multiple sclerosis and innovative haemophilia
therapies. For more information, please visit and follow us on
Biogen Safe Harbor

This press release contains forward-looking statements, including statements
about the potential benefits of Alprolix® in haemophilia B, including any
changes in the treatment approach for patients with haemophilia B. These
forward-looking statements may be accompanied by such words as "anticipate,"
"believe," "could," "estimate," "expect," "forecast," "intend," "may,"
"plan," "potential," "project," "target," "will" and other words and terms of
similar meaning. You should not place undue reliance on these statements.
These statements involve risks and uncertainties that could cause actual
results to differ materially from those reflected in such statements,
including uncertainty of success in commercialization of Alprolix, which may
be impacted by, among other things, slower than anticipated acceptance of
Alprolix by patients and the medical community, competition in the hemophilia
market, the effectiveness of sales and marketing efforts, dependence on third
party collaborations and collaborators, problems with the manufacturing
process for Alprolix, the occurrence of adverse safety events, difficulties
in obtaining or changes in the availability of reimbursement for our
products, failure to obtain regulatory approvals in other jurisdictions,
failure to protect intellectual property and other proprietary rights,
product liability claims and the other risks and uncertainties that are
described in the Risk Factors section of our most recent annual or quarterly
report and in other reports we have filed with the U.S. Securities and
Exchange Commission (SEC). Any forward-looking statements speak only as of
the date of this press release and we assume no obligation to update any
forward-looking statements, whether as a result of new information, future
events, or otherwise.

For more information please contact:

| Sobi |
| Media relations Investor relations |
| Oskar Bosson, Head of Communications Jörgen Winroth, Vice President, Head of Investor Relations |
| T: +46 70 410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135 |
| |
| |
| Biogen |
| Media contact Investor relations |
| Todd Cooper Benjamin Strain |
|+1-781-464-3260 1-781-464-2442 |
| |
| |
| Benjamin Russell |
|+41 41 392 1702 |
| |

---------------------------------------[1]World Federation of Hemophilia. About Bleeding Disorders - Frequently Asked
Questions. Available
at: Accessed on:
February 11, 2016.
[2]World Federation of Hemophilia. Report on the Annual Global Survey 2013.
Available at: Accessed
on: February 11, 2016.

025e_Alprolix approved in the EU


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


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