PRAGUE, CZECH REPUBLIC, October 11 /CNW/ - Biogen Idec (NASDAQ: BIIB)
today announced that nearly 25 posters and symposia sponsored by the company
will be presented at the 23rd Congress of the European Committee for Treatment
and Research of Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic. These
presentations and symposia will cover five agents that are marketed or
currently in development by Biogen Idec and its partners for the treatment of
multiple sclerosis (MS). The two approved therapies for MS are
TYSABRI(R)(natalizumab) and AVONEX(R) (Interferon beta-1a); and agents in
development are BG-12 (dimethyl fumarate), daclizumab and RITUXAN(R)
"The number of presentations and symposia by Biogen Idec at ECTRIMS are
evidence of our dedication and leadership in discovering and developing
treatments for multiple sclerosis patients," said Alfred Sandrock, MD, PhD,
Senior Vice President, Neurology Research and Development, Biogen Idec.
"Biogen Idec strives to provide a continuum of care for all MS patients at
every stage of their disease. Building upon the foundation that we established
with TYSABRI and AVONEX, our extensive clinical pipeline looks to the future.
In addition, our compounds in earlier stages of development target such unmet
needs as neurodegeneration and remyelination, with the goal to reverse the
damage inflicted by MS."
The following are selected highlights of presentations at ECTRIMS:
-- Use of natalizumab in patients with relapsing multiple sclerosis:
updated safety results from TOUCH(TM) and TYGRIS (Poster #565 - Saturday,
October 13, 2007, 3:30 p.m. CEST)
-- Natalizumab increases the proportion of patients with multiple
sclerosis who are disease-free (Poster #567 - Saturday, October 13, 2007, 3:30
-- The effect of plasma exchange in accelerating clearance of
natalizumab in patients with multiple sclerosis: results of the PLEX study
(Poster #576 - Saturday, October 13, 2007, 3:30 p.m. CEST)
-- Progression of disability at two years predicts disability at eight
years: analysis from the Phase III clinical trial of intramuscular Interferon
beta-1a (Poster #195 - Friday, October 12, 2007, 3:30 p.m. CEST)
-- Final results from the Global QUASIMS Study: a worldwide comparative
study of the efficacy and tolerability of interferon-beta products for the
treatment of relapsing multiple sclerosis (Poster #197 - Friday, October 12,
2007, 3:30 p.m. CEST)
-- Two Phase III studies to determine the efficacy and safety of BG-12,
a novel, oral fumaric acid derivative, in patients with relapsing multiple
sclerosis (Poster #579 - Saturday, October 13, 2007, 3:30 p.m. CEST)
-- Activation of Nrf2 and modulation of disease progression in EAE
models by BG-12 (dimethyl fumarate) suggests a novel mechanism of action
combining anti-inflammatory and neuroprotective modalities (Poster #503 -
Friday, October 12, 2007, 3:30 p.m. CEST)
"We are excited about BG-12's novel, dual mechanism of action," continued
Dr. Sandrock. "With approval to run the Phase III studies in 17 countries, we
are pleased to have a global program that offers both anti-inflammatory and
neuroprotective properties to patients in need."
Daclizumab is a humanized monoclonal antibody to the IL-2 receptor of T
cells that is in Phase II development for MS.
-- Preliminary CHOICE results: a Phase II, randomised, double-blind,
placebo-controlled multicentre study of subcutaneous daclizumab in patients
with active, relapsing forms of multiple sclerosis on interferon beta
(Platform Presentation #50 - Friday, October 12, 2007, 2:50 p.m. CEST)
RITUXAN is a targeted B-cell therapy that is in development for MS.
-- Safety and efficacy of rituximab in adults with relapsing-remitting
multiple sclerosis: results of a Phase II placebo-controlled, multicentre
trial through 48 weeks (Poster #554 - Saturday, October 13, 2007, 3:30 p.m.
Biogen Idec and Elan Corporation, plc will also be hosting two symposia
during ECTRIMS: "Optimising MS therapy to fit patients' lives" will be held on
Thursday, October 11, 2007 at 2:30 p.m. CEST and "Urgency to treat: can we
modify the course of MS?" will be held on Friday, October 12, 2007 at 6:00
p.m. CEST. Both symposia will be held in the Main Hall of the Prague Congress
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 in more than 90 countries 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 Our Products
TYSABRI is a treatment approved for relapsing forms of MS in the United
States and relapsing-remitting MS in the European Union. According to data
that have been published in the New England Journal of Medicine, after two
years, TYSABRI treatment led to a 68% relative reduction (p(less than)0.001)
in the annualized relapse rate compared to placebo and reduced the relative
risk of disability progression by 42-54% (p(less than)0.001).
TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain that usually leads to
death or severe disability. Other serious adverse events that have occurred in
TYSABRI-treated patients included hypersensitivity reactions (e.g.,
anaphylaxis) and infections. Serious opportunistic and other atypical
infections have been observed in TYSABRI-treated patients, some of whom were
receiving concurrent immunosuppressants. Herpes infections were slightly more
common in patients treated with TYSABRI. In MS trials, the incidence and rate
of other serious and common adverse events, including the overall incidence
and rate of infections, were balanced between treatment groups. Common adverse
events reported in TYSABRI-treated patients include headache, fatigue,
infusion reactions, urinary tract infections, joint and limb pain, and rash.
In addition to the United States and European Union, TYSABRI is also
approved in Switzerland, Canada, Australia, New Zealand and Israel. TYSABRI
was discovered by Elan and is co-developed with Biogen Idec.
AVONEX is the most prescribed treatment for relapsing forms of MS
worldwide, with more than 130,000 patients on therapy. It is used worldwide as
a treatment for relapsing forms of MS to slow the progression of disability
and reduce relapses. AVONEX is also approved for patients who have their first
clinical MS attack and have a brain MRI scan consistent with MS. The most
common side effects associated with AVONEX multiple sclerosis treatment are
flu-like symptoms, including myalgia, fever, fatigue, headache, chills,
nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other
mood disorders and in patients with seizure disorders. AVONEX should not be
used by pregnant women. Patients with cardiac disease should be closely
monitored. Patients should also be monitored for signs of hepatic injury.
Although daclizumab is currently marketed for other uses, it is not
approved for use in patients with multiple sclerosis.
Although RITUXAN is currently marketed for other uses, it is not approved
for use in patients with multiple sclerosis.
For full prescribing information on TYSABRI and warnings that come with
the product, please visit www.tysabri.com. For full prescribing information on
AVONEX, please visit www.avonex.com. For full prescribing information on
RITUXAN, please visit www.rituxan.com.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements about our expected
product sales, product development and other matters. Forward-looking
statements are subject to risks and uncertainties that could cause actual
results to differ materially from that which we expect. The commercial
potential of products in pre-clinical and clinical development is subject to a
number of risks and uncertainties, including the risk of unexpected delays or
hurdles and the uncertainty of obtaining regulatory approval. Drug development
and commercialization involves a high degree of risk. Additional factors that
could cause our actual results to differ include our continued dependence on
our two principal products, AVONEX and RITUXAN, the uncertainty of success in
commercializing other products including TYSABRI, the occurrence of adverse
safety events with our products, the failure to execute our growth strategy
successfully or to compete effectively in our markets, our dependence on
collaborations over which we may not always have full control, possible
adverse impact of government regulation and changes in the availability of
reimbursement for our products, problems with our manufacturing processes and
our reliance on third parties, fluctuations in our operating results, our
ability to protect our intellectual property rights and the cost of doing so,
the risks of doing business internationally and the other risks and
uncertainties that are described in Item 1A "Risk Factors" in our most recent
Form 10-Q filing with the SEC. These forward-looking statements speak only as
of the date of this press release, and we do not undertake any obligation to
publicly update any forward-looking statements, whether as a result of new
information, future events, or otherwise.
For further information:
For further information: Media Contacts: Biogen Idec Shannon Altimari,
617-914-6524 or Investor Contacts: Biogen Idec Eric Hoffman, 617-679-2812