Health Canada Approves Biogen Idec's Long-Acting ALPROLIX™ Therapy for Hemophilia B

Health Canada Approves Biogen Idec's Long-Acting ALPROLIX™ Therapy for 
Hemophilia B 
The Approval of ALPROLIX is First Significant Advance in Hemophilia B 
Treatment in More Than 17 Years 
CAMBRIDGE, MA, March 24, 2014 /CNW/ - Biogen Idec (NASDAQ: BIIB) has announced 
that Health Canada approved ALPROLIX(™ )[Coagulation Factor IX 
(Recombinant), Fc Fusion Protein], for the control and prevention of bleeding 
episodes and routine prophylaxis in adults, and children aged 12 and older, 
with hemophilia B. ALPROLIX is the first approved long-acting hemophilia B 
therapy and is indicated to prevent or reduce the frequency of bleeding 
episodes with prophylactic (protective) infusions starting at once weekly or 
once every 10-14 days. 
This is the first regulatory approval worldwide for ALPROLIX, which is 
currently under review by regulatory authorities in several other countries, 
including the United States, Australia and Japan. 
"Health Canada's approval of ALPROLIX marks the first significant treatment 
advance in hemophilia B in 17 years, and reinforces our commitment to 
developing innovative therapies that help address the critical needs of the 
hemophilia community," said George A. Scangos, Ph.D., chief executive officer 
of Biogen Idec. "We believe that the safety, efficacy and prophylactic dosing 
schedule demonstrated with ALPROLIX will provide people with hemophilia B a 
meaningful new way to manage their condition." 
The World Federation of Hemophilia recommends a prophylactic (prevention of 
bleeding) regimen as the goal of treatment for people with severe 
hemophilia.(i,ii,iii) Guidelines established by the Medical and Scientific 
Advisory Council of the National Hemophilia Foundation recommend prophylactic 
infusions two or more times a week with traditional hemophilia treatments.(iv) 
Frequent prophylactic infusions can be a burden to people with hemophilia and 
may reduce adoption to this type of treatment regimen.(v) 
The Health Canada approval of ALPROLIX is based on results from the global, 
Phase 3 B-LONG study, the largest registrational study in hemophilia B ever 
completed. It demonstrated that ALPROLIX safely and effectively prevented, or 
reduced, bleeding episodes with prophylactic infusions given once weekly or 
once every 10-14 days in adults and adolescents with severe hemophilia B. In 
addition, more than 90 per cent of all bleeding episodes were controlled by a 
single ALPROLIX infusion. 
"Health Canada's approval of ALPROLIX provides people with hemophilia B an 
important new option in maintaining a prophylactic regimen," said Manuel 
Carcao, M.D., Pediatric Hematologist and co-director of the Comprehensive Care 
Hemophilia Program at the Hospital for Sick Children in Toronto. "ALPROLIX, 
the first approved long-acting factor concentrate, has been shown to help 
individuals with hemophilia B achieve effective bleed prevention with 
prophylactic dosing once a week or once every 10 to 14 days." 
Hemophilia B is a rare, chronic, inherited disorder in which the ability of a 
person's blood to clot is impaired, which can lead to recurrent and extended 
bleeding episodes. It is due to a substantial reduction of, or no factor IX 
activity, which is needed for normal blood clotting. People with hemophilia B 
experience bleeding episodes that can cause pain, irreversible joint damage 
and hemorrhage. Hemophilia B affects approximately one in 25,000 male births, 
or about 700 people in Canada.(vi) The World Federation of Hemophilia global 
survey conducted in 2012 estimates that about 28,000 people are currently 
diagnosed with hemophilia B worldwide. 
"The Canadian Hemophilia Society (CHS) is pleased that Health Canada has 
approved ALPROLIX, a second recombinant factor IX product to treat hemophilia 
B," said Craig Upshaw, CHS President. "Moreover, it is the first in a 
promising new class of factor products with extended half-life. We hope it 
will be available to Canadian patients in the very near future." 
Biogen Idec is committed to helping people with hemophilia B and is working 
with Canadian Blood Services, the Service de Biovigilance du Ministère de la 
Santé et des Services sociaux and other provincial and national authorities 
to make ALPROLIX commercially available to all Canadians with hemophilia B. 
About the B-LONG Study  B-LONG was a global, open-label, multi-center phase 3 
study that evaluated the efficacy, safety and pharmacokinetics (measurement of 
the presence of the therapy in a patient's body over time), of ALPROLIX in 123 
males aged 12 years and older with hemophilia B. These findings were published 
in the December 12, 2013 issue of The New England Journal of Medicine. The 
study involved 50 hemophilia treatment centers in 17 countries, on six 
The overall median annualized bleeding rates (ABR), or projected rate of 
bleeding episodes per year, reported in the study were 2.95 for the weekly 
prophylaxis arm and 1.38 for the individualized-interval prophylactic regimens 
arm, in which the dosing interval started at every 10 days, and 17.69 in the 
on-demand treatment arm. The overall median dosing interval with 
individualized-interval prophylaxis was 12.5 days. During the last six months 
of the study the median dosing interval was 13.8 days. 
The most common adverse events (incidence of ≥5 per cent in a pooled 
analysis of groups 1, 2, and 3) were nasopharyngitis (common cold), influenza 
(flu), arthralgia (joint pain), upper respiratory tract infection, 
hypertension (high blood pressure) and headache. 
About ALPROLIX  ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion 
Protein] is the first long-acting fully recombinant clotting factor therapy. 
It is indicated for the control and prevention of bleeding episodes and 
routine prophylaxis in adults, and children 12 years and older, with 
hemophilia B. ALPROLIX is developed by fusing factor IX to the Fc portion of 
Immunoglobulin G Subclass 1, or IgG(1) (protein commonly found in the body). 
It is believed that this enables ALPROLIX ( )to use a naturally occurring 
pathway to prolong the time therapy remains in the body. While Fc fusion has 
been used for more than 15 years, Biogen Idec is the only company to apply it 
in hemophilia. 
The most common adverse drug reactions observed in the clinical trial 
(incidence ≥ 1%) were headaches and oral paresthesia (an abnormal sensation 
in the mouth). 
About the Biogen Idec and Sobi Collaboration Biogen Idec and Swedish Orphan 
Biovitrum (Sobi) are partners in the development and commercialization of 
ALPROLIX for hemophilia B. Biogen Idec leads development, has manufacturing 
rights, and has commercialization rights in North America and all other 
regions in the world excluding the Sobi territory. Sobi has the right to opt 
in to assume final development and commercialization in Europe, Russia, the 
Middle East and Northern Africa. 
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, hemophilia 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. For product labeling, press releases and additional 
information about the company, please visit 
Biogen Idec Safe Harbor This press release contains forward-looking 
statements, including statements about the potential and therapeutic impact of 
ALPROLIX. 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 our commercialization of ALPROLIX, which 
may be impacted by, among other things, slower than anticipated acceptance of 
ALPROLIX by patients and the medical community, intense competition in the 
hemophilia market, the effectiveness of our sales force and marketing efforts, 
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, our failure to obtain 
regulatory approvals in jurisdictions outside of Canada, including in the 
event other companies receive marketing approval of their treatments before 
approval of our treatments, our failure to protect our 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. 
(i) Nilsson IM, Berntorp E, Löfqvist T, Pettersson H. Twenty-five years' 
experience of prophylactic treatment in severe haemophilia A and B. J Intern 
Med 1992;232:25-32. (ii) Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. 
Prophylaxis versus episodic treatment to prevent joint disease in boys with 
severe hemophilia. N Engl J Med 2007;357:535-44. (iii) Panicker J, Warrier I, 
Thomas R, Lusher JM. The overall effectiveness of prophylaxis in severe 
haemophilia. Haemophilia : the official journal of the World Federation of 
Hemophilia 2003;9:272-8. (iv) 
(v) Hacker MR, Geraghty S, Manco-Johnson M. Barriers to compliance with 
prophylaxis therapy in haemophilia. Haemophilia : the official journal of the 
World Federation of Hemophilia 2001;7:392-6. (vi) Canadian Hemophilia 
Registry. Hemophilia B.  
Accessed February 18, 2014. 

SOURCE  Biogen Idec Canada 
Media Contact: Lee-Ann Murphy, +1-781-464-5075,; 
Canadian Media Contact: Rick Maddalena, +1-416-486-7225,; Investor Relations Contact: Ben Strain, 
+1-781-464-2442,; French Canadian Media Contact: Joëlle 
Paquette, +1-418-529-3223, poste 33, 
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