Health Canada Approves Biogen Idec's Long-Acting ALPROLIX™ Therapy for
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
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 www.biogenidec.com.
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.http://www.fhs.mcmaster.ca/chr/pdf/13/CHRIX130517b.pdf
Accessed February 18, 2014.
SOURCE Biogen Idec Canada
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