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