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Swedish Orphan Biovitrum AB (publ): Sobi and Biogen receive positive opinion from CHMP for Alprolix® (rFIXFc) for the treatment of haemophilia B

Swedish Orphan Biovitrum AB (publ) (Sobi(TM))(STO: SOBI) andBiogen(NASDAQ:
BIIB) received a positive opinion from the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that
marketing authorisation be granted for Alprolix® (rFIXFc), a recombinant
factor IX Fc fusion protein therapy for the treatment of haemophilia B. If
approved, Alprolix would be among the first therapies in the European Union
(EU) to offer people living with haemophilia B prolonged protection against
bleeding episodes with prophylactic dosing intervals.

"This positive opinion marks an important step in our efforts to bring
treatment innovation to people with haemophilia in Europe and around the
world," said Krassimir Mitchev, M.D., Ph.D., vice president and medical
therapeutic area head of Haemophilia at Sobi. "We are already seeing the
benefits that Fc fusion technology can offer through our recent EU launch of
Elocta® for people with haemophilia A. We are excited at the prospect of also
offering the possibility for prolonged protection and reduced treatment
burden to the haemophilia B community with Alprolix."

The positive opinion 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 CHMP's recommendation is now referred to the
European Commission (EC), which is responsible for granting marketing
authorisation for medicines in the EU.

"Therapies that offer prolonged protection from bleeds are changing the way
many approach treatment of haemophilia," said Gilmore O'Neill, M.D., senior
vice president, Drug Innovation Units at Biogen. "We are proud to work with
Sobi to continue bringing to Europe these innovative Fc fusion therapies,
which are grounded in the most robust real-world experience of any prolonged
circulation factor therapies to date."

Sobi and Biogen are collaboration partners in 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 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 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 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 U.S.,
Canada, Japan, Australia and New Zealand, where it was the first haemophilia
B therapy approved 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 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 hemophilia
therapies. For more information, please Follow us on

About Sobi(TM)

Sobi(TM) 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 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

Biogen Safe Harbour

This press release contains forward-looking statements, including statements
about the potential benefits of ALPROLIX, and its potential approvability in
the EU. These statements may be identified by words such as "believe,"
"expect," "may," "plan," "potential," "will," and similar expressions, and
are based on our current beliefs and expectations. Drug development and
commercialization involve a high degree of risk. Factors which could cause
actual results to differ materially from our current expectations include the
risk that unexpected concerns may arise from additional data or analysis,
regulatory authorities may require additional data or information or further
studies, or may fail to approve, or refuse to approve, or may delay approval
of our drug candidates, or we may encounter other unexpected hurdles. For
more detailed information on the risks and uncertainties associated with our
drug development and commercialization activities, please review the Risk
Factors section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. 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 |
| Kate Niazi-Sai Ben Strain |
|+1-781-464-3260 1-781-464-2442 |
| |
| |
| Ryan Furby |
| |
|+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.

010e_Alprolix_CHMP opinion


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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