Swedish Orphan Biovitrum AB (publ) : Biogen Idec and Sobi Present New Data from the Phase 3 Study of their Long-Lasting

  Swedish Orphan Biovitrum AB (publ) : Biogen Idec and Sobi Present New Data
  from the Phase 3 Study of their Long-Lasting Haemophilia Factor Candidate

Additional Analyses from Phase 3 A-LONG Study Support Positive Clinical
Profile of ELOCTATE for Haemophilia A

Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:
SOBI) presented new data that support the clinical and safety profile of their
long-lasting recombinant factor VIII candidate ELOCTATE* for haemophilia A.
Five platform and oral presentations at the XXIV International Society on
Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, The Netherlands,
highlight the new FVIII candidate's potential to reduce the number of
intravenous injections people with haemophilia A require, its efficacy in
controlling bleeding during and after surgery, and its efficacy in treating
acute bleeding episodes.

"We are excited to share these new data, which include patients' and
physicians' assessment of ELOCTATE's efficacy in treating bleeding episodes
and in controlling bleeding during surgery," said Glenn Pierce, M.D., Ph.D.,
senior vice president of Global Medical Affairs and chief medical officer of
Biogen Idec's haemophilia therapeutic area. "The A-LONG data presented at ISTH
support the potential of ELOCTATE to enable longer intervals between
prophylactic (preventative) injections compared to the current standard of

Treatment of Bleeding
An evaluation of the treatment of acute bleeding episodes across the
prophylaxis and episodic (on demand) treatment arms of the phase 3 A-LONG
study showed that more than 87% of bleeds were controlled with a single
injection of ELOCTATE and more than 97% of were controlled with two or fewer
injections. These data were showcased in the e-Poster presentation:

  *Treatment of Bleeding Episodes in Subjects with Haemophilia A With
    Long-Lasting Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the
    Phase 3 A-Long Study

Novel Assay Clinical Research
For the first time Biogen Idec shared results of evaluations of the
performance of ELOCTATE when evaluated using two investigational haemostasis

Results from a large scale, global clinical evaluation of ELOCTATE by thrombin
generation assay (TGA), using a standardized sample collection procedure and
an optimized and validated assay performed at a central laboratory showed
that, despite inherent patient-to-patient differences in thrombin generation
activity, ELOCTATE and Advate** showed equivalent thrombin generation
potential post-infusion. ELOCTATE also showed prolonged thrombin generation
activity relative to Advate, correlating with the pharmacokinetic data
observed in these subjects.

Results from a rotation thromboelastometry (ROTEM®) analysis conducted on 44
patients treated with ELOCTATE from 13 A-LONG study sites showed that ELOCTATE
was fully active in patient samples. Additionally, the FVIII activity as
measured by clotting time seen for ELOCTATE at 72 hours after dosing was
comparable to the activity of Advate at 48 hours after dosing (mean clotting
times of 1,238 seconds and 1,213 seconds, respectively).

The data presentations were consistent with conventional assay results from
the A-LONG study. These data were showcased in two oral platform

  *Evaluation of The Thrombin Generation Potential of a Recombinant Factor
    VIII Fc Fusion Protein in a Phase III Multi-National Clinical Trial
  *Evaluation of Whole Blood Clotting Activity of Recombinant Factor VIII Fc
    Fusion Protein by ROTEM Analysis in a Multi-Center Phase 3 Clinical Trial

Surgery Analysis
Results from an analysis of the phase 3 A-LONG study showed that ELOCTATE
consistently controlled bleeding during and after 9 major surgeries in 9
patients with haemophilia A.Physicians reported high efficacy levels of
ELOCTATE during surgery, with haemostasis (the stoppage of bleeding) rated as
"excellent" for 8/9 surgeries and "good" for 1/9 surgeries. According to the
investigators' analysis, the results were comparable to that for similar
surgeries in people without haemophilia. These data were showcased in the
e-poster presentation:

  *Long-Lasting Recombinant Factor VIII Fc Fusion (rFVIIIFc) for
    Perioperative Management of Subjects with Haemophilia A in the Phase 3
    A-LONG Study

Population Pharmacokinetics (PK) Analysis
Analysis of a population pharmacokinetics (popPK) model developed for ELOCTATE
demonstrate that the model accurately predicts peak and trough factor VIII
activity levels achieved in the A-LONG clinical study at a variety of ELOCTATE
doses. These data were showcased in the e-poster presentation:

  *Population Pharmacokinetic Analysis of Long-Lasting Recombinant Factor
    VIII Fc Fusion Protein (rFVIIIFc) in Patients with Severe Haemophilia A

"These new data from the A-LONG study show potential for the application of Fc
fusion technology in haemophilia," said Birgitte Volck, M.D., Ph.D., senior
vice president development and chief medical officer of Sobi. "We are excited
to share these data on ELOCTATE, which provide additional evidence of the
potential of ELOCTATE to make a meaningful difference in the lives of patients
with haemophilia A."

ELOCTATE Global Regulatory Status
A Biologics License Application (BLA) for Biogen Idec's long-lasting
haemophilia product candidate ELOCTATE is currently under review with the FDA
for the treatment of haemophilia A. If approved, ELOCTATE would be the first
major treatment advance for the haemophilia A community in more than two

A Marketing Application for ELOCTATE has been submitted in Australia for the
treatment of haemophilia A. Additional regulatory filings are planned. 


About the Fc Fusion Technology Platform
ELOCTATE is a clotting factor under development using Biogen Idec's novel and
proprietary monomeric Fc fusion technology, which makes use of a naturally
occurring pathway that delays the breakdown of factor in the body and cycles
it back into the bloodstream, resulting in a longer circulating half-life. Fc
fusion technology is used in seven FDA-approved products for the treatment of
chronic diseases including rheumatoid arthritis, psoriasis and platelet
disorders. Biogen Idec is the first and only to apply this proprietary
technology to haemophilia.

About Haemophilia A
Haemophilia A is a rare, inherited 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 is caused by having substantially reduced or no factor
VIII activity, which is needed for normal blood clotting. People with
haemophilia A experience bleeding episodes that can cause pain, irreversible
joint damage and life-threatening haemorrhage. Injections of factor VIII can
restore the coagulation process, control bleeding, and prevent new bleeding
episodes. The Medical and Scientific Advisory Council of the National
Haemophilia Foundation recommends prophylaxis as the optimal therapy for
people with severe haemophilia A. Currently, prophylaxis in haemophilia A
typically requires injections three times per week or every other day to
maintain a sufficient circulating level of clotting factor.

About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the
development and commercialization of ELOCTATE in haemophilia A and ALPROLIX in
haemophilia B. Biogen Idec leads development, has manufacturing rights, and
has commercialization rights in North America and all other regions excluding
the Sobi territory. Sobi has the right to opt in to assume final development
and commercialization in Europe (including Russia), the Middle East and
Northern Africa.

About Sobi
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on inflammation and genetic diseases, with three late stage biological
development projects within haemophilia and neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi
is a pioneer in biotechnology with world-class capabilities in protein
biochemistry and biologics manufacturing. In 2012, Sobi had total revenues of
SEK 1.9 billion (€ 215 M) and about 500 employees. The share (STO: SOBI) is
listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.

About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, haemophilia and autoimmune disorders. Founded in
1978, Biogen Idec is the world's oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies, and
the company generates more than $5 billion in annual revenues. For product
labelling, press releases and additional information about the company, please
visit www.biogenidec.com.

Safe Harbour

This press release contains forward-looking statements, including statements
about the potential impact and therapeutic effect of our long-lasting
haemophilia product candidates and regulatory filings. 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
information or further studies, or may fail 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.

*ELOCTATE(TM) Antihaemophilic Factor (Recombinant Fc Fusion Protein)
**Advate® [antihaemophilic factor (recombinant), plasma/albumin-free method]
is a registered trademark of Baxter International Inc.

For more information - not for publication

Media relations                  Investor relations
Oskar Bosson, Head of            Jörgen Winroth, Vice President, Head of
Communications                   Investor Relations
T: +46 70410 71 80              T: +1 347-224-0819 or +1 212-579-0506
oskar.bosson@sobi.com            jorgen.winroth@sobi.com
Biogen Idec
Media Contact                    Investor Relations Contact
Todd Cooper                      Ben Strain
Senior Director, Public Affairs  Senior Manager, Investor Relations
+1-781-464-3260                  +1-781-464-2442

Biogen Idec and Sobi Present New Data from the Phase 3 Study


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