Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their Long-Lasting Hemophilia Factor Candidate ELOCTATE™

  Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their
  Long-Lasting Hemophilia Factor Candidate ELOCTATE™

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

Business Wire

WESTON, Mass. and STOCKHOLM -- July 4, 2013

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 hemophilia 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 hemophilia 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 hemophilia 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
care.”

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 hemostasis
assays. 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
presentations:

  *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 hemophilia A. Physicians reported high efficacy levels of
ELOCTATE during surgery, with hemostasis (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 hemophilia. 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 hemophilia,” 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 hemophilia A.”

ELOCTATE Global Regulatory Status

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

A Marketing Application for ELOCTATE has been submitted in Australia for the
treatment of hemophilia 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 hemophilia.

About Hemophilia A

Hemophilia A is a rare, inherited disorder in which the ability of a person's
blood to clot is impaired. Hemophilia 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
hemophilia A experience bleeding episodes that can cause pain, irreversible
joint damage and life-threatening hemorrhage. 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
Hemophilia Foundation recommends prophylaxis as the optimal therapy for people
with severe hemophilia A. Currently, prophylaxis in hemophilia 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 hemophilia A and ALPROLIX in
hemophilia 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.

AboutBiogen Idec

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

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 hemophilia 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.

Biogen Idec Safe Harbor

This press release contains forward-looking statements, including statements
about the potential impact and therapeutic effect of our long-lasting
hemophilia 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 Antihemophilic Factor (Recombinant Fc Fusion Protein)
**Advate^® [antihemophilic factor (recombinant), plasma/albumin-free method]
is a registered trademark of Baxter International Inc.

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Contact:

BIOGEN IDEC
Media Contact:
Todd Cooper, +1-781-464-3260
Senior Director, Public Affairs
or
Investor Relations Contact:
Ben Strain, +1-781-464-2442
Senior Manager, Investor Relations
or
SWEDISH ORPHAN BIOVITRUM
Media Contact:
Oskar Bosson, +46 70 410 71 80
Head of Communications
or
Analyst/Investor Contact:
Jörgen Winroth, +1 347-224-0819 or +1 212-579-0506
Vice President, Head of Investor Relations
 
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