Biogen Idec and Sobi Present New Data from the Phase 3 Study of their Long-Lasting Haemophilia Factor Candidate ALPROLIX (TM)
Additional B-LONG Study Results Support Positive Clinical Profile of ALPROLIX
for Haemophilia B
Weston, Massachusetts, US and Stockholm, Sweden - 2 July, 2013 - Biogen Idec
(NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today
presented new findings for their long-lasting recombinant factor IX candidate
ALPROLIX* for haemophilia B at the XXIV International Society on Thrombosis and
Haemostasis (ISTH) Congress in Amsterdam, The Netherlands. Three oral
presentations showcase new data that reinforce the potential safety, efficacy
and pharmacokinetic profile of ALPROLIX. The data highlight the consistency of
results with ALPROLIX across patient types and favourable physician ratings of
its efficacy in treating acute bleeding episodes and controlling bleeding during
and after major surgery.
"ALPROLIX is the first product candidate in a new class of long-lasting clotting
factor therapies, and the data presented today support the potential of the
therapy to reduce the frequency of prophylactic infusions for patients with
haemophilia B," 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. "These new data help to build the clinical profile of ALPROLIX
by increasing our understanding of its efficacy."
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 B-LONG study showed that
more than 90% of bleeds were controlled with a single injection of ALPROLIX and
more than 97% were controlled with two or fewer injections. These data were
showcased in the e-poster presentation:
* Treatment of Bleeding Episodes in Subjects with Haemophilia B with the Long-
Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-
LONG Study
Surgery Analysis
Results from an analysis of the phase 3 B-LONG study showed that ALPROLIX
consistently controlled bleeding during and after 14 major surgeries in 12
patients with haemophilia B. Physicians reported high efficacy levels of
ALPROLIX during surgery, with haemostasis (the stoppage of bleeding) rated as
"excellent" for 13/14 surgeries and "good" for 1/14 surgeries. According to
investigator analyses, 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 IX Fc Fusion (rFIXFc) for Perioperative
Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study
Population Pharmacokinetics (PK) Analysis
Analysis of a population pharmacokinetics (popPK) model developed for ALPROLIX
demonstrated that the model accurately predicts peak and trough factor IX
activity levels achieved in the B-LONG clinical study at a variety of ALPROLIX
doses. These data were showcased in the e-poster presentation:
* Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine
Prophylaxis, Control of Bleeding and Perioperative Management for
Haemophilia B Patients
"These new data from the B-LONG study support the potential application of Fc
fusion technology in haemophilia," said Birgitte Volck, M.D., Ph.D., senior vice
president development and chief medical officer of Sobi. "The results add to the
growing body of evidence supporting the potential efficacy and safety of this
long-lasting clotting factor candidate for the treatment of haemophilia B."
ALPROLIX Global Regulatory Status
A Biologics License Application (BLA) for Biogen Idec's long-lasting haemophilia
product candidate ALPROLIX is currently under review with the U.S. Food and Drug
Administration (FDA) for the treatment of haemophilia B.
Marketing Applications for ALPROLIX have been submitted in Canada and Australia
for the treatment of haemophilia B. Additional regulatory filings are planned.
---
About the Fc Fusion Technology Platform
ALPROLIX 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 B
Haemophilia B is a rare, inherited disorder in which the ability of a person's
blood to clot is impaired. Haemophilia B occurs in about one in 25,000 male
births annually and is caused by having substantially reduced or no factor IX
activity, which is needed for normal blood clotting. People with haemophilia B
experience bleeding episodes that can cause pain, irreversible joint damage and
life-threatening haemorrhage. Injections of factor IX 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
B. According to the World Federation of Haemophilia, prophylaxis in haemophilia
B typically requires injections up to three times per week 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 Statement
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.
*ALPROLIX(TM) Coagulation Factor IX (Recombinant Fc Fusion Protein)
For more information - not for
publication
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: +46 8 697 20 00
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
