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This excerpt taken from the ELN 6-K filed Sep 19, 2008. Montreal, Canada – September 19, 2008
– Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN)
announced that a post-hoc analysis showed TYSABRI®
(natalizumab) treatment increases the probability of achieving sustained
improvement in physical disability over two years when compared to
placebo. This post-hoc analysis provides the first evidence that
TYSABRI is associated with a significant improvement in functional outcome,
rather than only slowing or preventing progression of disability, in those
living with relapsing multiple sclerosis (MS). These findings were
derived from a subset analysis of the Phase III AFFIRM trial and were presented
today as a poster presentation at the World Congress on Treatment and Research
in Multiple Sclerosis in Montreal, Canada. This is the first joint
meeting of the Americas Committee on Treatment and Research in Multiple
Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS
and LACTRIMS.
“These
results show that TYSABRI treated patients are significantly more likely to
experience a sustained improvement in disability compared to placebo patients.
This finding from a post-hoc Tysabri
Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis
Patients According to New Post-Hoc Analysis
analysis
of the pivotal AFFIRM trial supports both the earlier findings from the AFFIRM
trial that TYSABRI is associated with an improvement in quality of life as well
as anecdotal evidence of recovery of function in some patients.” said Frederick
E. Munschauer, MD, Smith Professor and Chair, Department of Neurology, State
University of New York at Buffalo. “While, like TYSABRI, other therapies have
shown a slowing of progression in disability, this analysis represents the first
evidence supporting a sustained improvement in function associated with an
approved disease modifying therapy.”
Post-hoc
Disability Analysis of Phase III AFFIRM Study
The
proportion of patients exhibiting sustained improvements in physical disability
in the AFFIRM study was determined based upon the Expanded Disability Status
Scale (EDSS) over two years in patients with relapsing MS. EDSS is one of the
oldest and most widely utilized methods of quantifying disability in
MS.
Post-hoc
analysis of AFFIRM patients assessed sustained improvement in disability among
patients with a baseline EDSS score ≥ 2.0. Improvement in disability
was defined as a one-point decrease in EDSS score sustained for 12
weeks. The cumulative probabilities of 12-week sustained improvement
in disability at two years were estimated using the Kaplan-Meier
method. Treatment effects were analyzed using the Cox proportional
hazards model adjusted for baseline EDSS score. The distribution of sustained
improvement by baseline EDSS score for each treatment group was also
examined.
TYSABRI
produced significant results on the cumulative probability of sustained
improvement in disability in those treated over two years compared with
placebo. In patients with a baseline EDSS score ≥ 2.0, the
probability of achieving sustained improvement was 29.6% with TYSABRI (n=417)
compared with 18.7% with placebo (n=203) (p=0.006). In
patients with an EDSS score ≥ 2.0 and highly active disease at baseline, the
difference between groups was even greater, 35.5% for TYSABRI (n=103) and 15.4%
for placebo (n=40) (p=0.045).
The
submitted abstract for this study, entitled “Natalizumab significantly increases
the cumulative probability of sustained improvement in physical disability” (ID
#P474), is available on the World Congress’ website.
About
TYSABRI
TYSABRI
is a treatment approved for relapsing forms of MS in the US 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<0.001) in the annualized
relapse rate compared to placebo and reduced the relative risk of disability
progression by 42-54% (p<0.001).
TYSABRI
was approved in early 2008 to induce and maintain clinical response and
remission in adult patients with moderately to severely active Crohn's disease
(CD) with evidence of inflammation who have had an inadequate response to, or
are unable to tolerate, conventional CD therapies and inhibitors of
TNF-alpha. According to the US full prescribing information,
among patients who responded to TYSABRI, 54% sustain their response through
every visit for one year compared to 20% of patients receiving placebo
(p<0.001), for a treatment difference of 34%. 2
Tysabri
Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis
Patients According to New Post-Hoc Analysis
TYSABRI
increases the risk of progressive multifocal leukoencephalopathy (PML), an
opportunistic viral infection of the brain that usually leads to death or severe
disability. Cases of PML have been reported in patients taking TYSABRI who were
recently or concomitantly treated with immunomodulators or immunosuppressants,
as well as in patients receiving TYSABRI as monotherapy. 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 and CD clinical trials, the incidence and
rate of other serious adverse events, including serious infections, were similar
in patients receiving TYSABRI and those receiving placebo. Common
adverse events reported in TYSABRI-treated MS patients include headache,
fatigue, infusion reactions, urinary tract infections, joint and limb pain and
rash. Other common adverse events reported in TYSABRI-treated CD
patients include respiratory tract infections and nausea. Clinically significant
liver injury has been reported in patients treated with TYSABRI in the
post-marketing setting.
TYSABRI
is approved in more than 35 countries. At the end of June 2008, more
than 31,800 patients were on commercial and clinical TYSABRI therapy
worldwide. Patients on TYSABRI therapy have continued to
increase. An update will be provided in October in conjunction with
Biogen Idec's third quarter earnings release.
For more
information about TYSABRI please visit www.tysabri.com,
www.biogenidec.com or
www.elan.com or
call 1-800-456-2255.
About
Elan
Elan
Corporation, plc is a neuroscience-based biotechnology company committed to
making a difference in the lives of patients and their families by dedicating
itself to bringing innovations in science to fill significant unmet medical
needs that continue to exist around the world. Elan shares trade on the New
York, London and Dublin Stock Exchanges. For additional information about the
company, please visit www.elan.com.
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.
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