WESTON, MA and STOCKHOLM, SWEDEN--(Marketwire - July 12, 2010) -
Biogen Idec (NASDAQ: BIIB)
and Swedish Orphan Biovitrum AB (STO: SOBI) today announced results from a
Phase
1/2a open-label, dose-escalation, safety and pharmacokinetic study of
the
companies' long-lasting, fully-recombinant factor IX Fc fusion protein
(rFIXFc)
in hemophilia B patients. The data, which were presented at the World
Federation
of Hemophilia Congress in Buenos Aires, Argentina, on July 11, 2010, showed
that
rFIXFc was well tolerated and demonstrated an approximately three-fold
increase
in half-life compared to historical data for existing therapies.
"Current prophylactic regimens for hemophilia B require two to three
intravenous
injections per week, so there is great desire among physicians and
patients for
a therapy that will provide prolonged protection from bleeding,"
said Amy
Shapiro, M.D., Medical Director of the Indiana Hemophilia and Thrombosis
Center.
"Results from the Phase 1/2a trial show that rFIXFc may be able to
reduce the
number of injections to once weekly or less, which would be an
important
advancement for the hemophilia community."
"Our hemophilia B program demonstrates Biogen Idec's commitment to
utilizing
pioneering science to create new standards of care for patients," said
Glenn
Pierce, M.D., Ph.D., Vice President and Chief Medical Officer of Biogen
Idec's
hemophilia therapeutic area. "Developed using our novel Fc-fusion
technology,
rFIXFc has the potential to improve the lives of individuals with
hemophilia B
by providing longer-lasting protection from bleeding."
Based on positive results from the Phase 1/2a trial, rFIXFc was advanced
into a
global registrational trial called B-LONG in January. B-LONG is
designed to
assess the safety, pharmacokinetics and efficacy of rFIXFc in the
prevention and
treatment of bleeding in 75 previously-treated people with severe
hemophilia B.
rFIXFc's ability to prevent bleeding using different dosing regimens is
being
measured by evaluating the number of breakthrough bleeding episodes.
"We look forward to results from the registrational trial and are excited
about
the potential of rFIXFc to significantly reduce the frequency of
injections
necessary for people with hemophilia B," said Peter Edman, Ph.D.,
Chief
Scientific Officer of Swedish Orphan Biovitrum.
Using the same proprietary technology as rFIXFc, Biogen Idec and Swedish
Orphan
Biovitrum are also developing a recombinant, long-lasting Factor VIII Fc
fusion
protein (rFVIIIFc) for the treatment of hemophilia A. The companies
recently
announced their decision to advance rFVIIIFc into a registrational trial
based
on positive results from a Phase 1/2a open-label, cross-over, dose-
escalation
study designed to evaluate the safety and pharmacokinetics of rFVIIIFc in
people
with severe hemophilia A. For more information on the rFIXFc and
rFVIIIFc
trials, please visit www.biogenidechemophilia.com or
www.clinicaltrials.gov.
About the Study
Study SYN-FIXFc-07-001, a Phase 1/2a study of rFIXFc in 14 previously-
treated
patients with severe hemophilia B ( = 2 U/dL endogenous FIX), was designed
as an
open-label, multi-center, dose-escalation study to evaluate the
safety and
pharmacokinetics (PK) of a single dose of rFIXFc given as an
intravenous
injection. The dose levels investigated ranged from 1 to 100 IU/kg, which
were
determined based on non-clinical data and data from factor IX
products in
clinical use. The primary objective of the study was to assess the
safety of
rFIXFc at different doses; the secondary objective was to estimate
the PK
parameters of rFIXFc at doses ranging from 12.5 to 100 IU/kg.
rFIXFc was generally well tolerated in this single-dose study and there
were no
signs of injection site reactions, inhibitor development or anti-rFIXFc
drug
antibodies. There have been no reports of drug-related serious adverse
events. A
total of two adverse events, headache and altered taste, were
reported as
related to rFIXFc dosing. Additionally, rFIXFc demonstrated an
approximately
three-fold increase in half-life (52.5±9.2 hours) compared to data
reported in
the literature for existing factor IX therapies. Other PK parameters
such as
mean residence time and area under the curve (AUC) were similarly
increased. The
incremental recovery of rFIXFc appeared to more closely
approximate
plasma-derived factor IX, in contrast to results for other
recombinant
DNA-produced factor IX products. Furthermore, peak serum concentration
and AUC
also demonstrated an increase proportional to the dose administered.
Together,
these data support the hypothesis that rFIXFc may provide prolonged
protection
from bleeding.
About Hemophilia
Hemophilia is a rare, inherited disorder in which the ability of a
person's
blood to clot is impaired. Hemophilia B occurs in about one in 25,000
male
births annually and is caused by having substantially reduced or no
factor IX
protein, which is needed for normal blood clotting. People with
hemophilia B
therefore need injections of factor IX to restore the coagulation
process and
prevent frequent bleeds that could otherwise lead to pain, irreversible
joint
damage and life-threatening hemorrhages. Prophylactic treatment with
infusions
twice per week to maintain a sufficient circulating level of coagulation
factor
is being increasingly used, and long-term studies demonstrate that such
regimens
increase the patient's life expectancy and greatly reduce, if not
eliminate,
progressive joint deterioration.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high
unmet
medical needs. Founded in 1978, Biogen Idec is a global leader in the
discovery,
development, manufacturing, and commercialization of innovative
therapies.
Patients worldwide benefit from Biogen Idec's significant products that
address
diseases such as lymphoma, multiple sclerosis, and rheumatoid
arthritis. For
product labeling, press releases and additional information about the
company,
please visit www.biogenidec.com.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty
pharmaceutical
company with an international market presence. The company is
focused on
providing and developing specialist pharmaceuticals for rare disease
patients
with high medical needs. The portfolio consists of about 60 marketed
products
and an emerging late stage clinical development pipe-line. Our focus areas
are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption,
cancer
supportive care and inherited metabolic disorders.
Swedish Orphan Biovitrum had pro-forma revenues 2009e of about 2
BSEK and
approximately 500 employees. The head office is located in Sweden and the
share
(STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information please
visit
www.sobi.com.
For more information contact:
Biogen Idec Media Contact: Swedish Orphan Biovitrum
Tracy Vineis, Senior Manager, Peter Edman, CSO
Public Affairs Phone: +46 8 629 21 77
Phone: +1 (781) 464-3260 peter.edman@sobi.com
Biogen Idec Investor Relations Erik Kinnman, VP Investor Relations and
Contact: Public Affairs
Kia Khaleghpour Phone: +46 73 422 15 40
Associate Director, Investor erik.kinnman@sobi.com
Relations
Phone: +1 (781) 464-2442 Martin Nicklasson, CEO
Phone: +46 8 697 20 00
Safe Harbor
This press release contains forward-looking statements regarding the
development
of long-lasting hemophilia therapies, which may be identified by words
such as
"believe," "expect," "may," "plan," "will" and similar expressions.
These
statements are based on the companies' current beliefs and expectation.
Drug
development involves a high degree of risk. Factors which could cause
actual
results to differ materially from the companies' current expectations
include
the risk that we may not fully enroll our planned clinical trials,
unexpected
concerns may arise from additional data or analysis, regulatory
authorities may
require additional information, further studies, or may fail to
approve the
drug, or the companies may encounter other unexpected hurdles. For more
detailed
information on the risks and uncertainties associated with Biogen Idec's
drug
development and other activities, see the periodic reports of Biogen Idec
filed
with the Securities and Exchange Commission. Any forward-looking
statements
speak only as of the date of this press release and the companies
assume no
obligation to update any forward-looking statements, whether as a result
of new
information, future events or otherwise.
Swedish Orphan Biovitrum may be required to disclose the information
provided
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on July 12, 2010 at 8:30 a.m. CET.
[HUG#1430956]
Press Release July 12, 2010:
http://hugin.info/134557/R/1430956/377500.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE
