-- TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in
Disability Progression and Sustained Improvement in Physical Disability --
Elan Corporation PLC
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that
a post-hoc analysis showed TYSABRI(R) (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 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 > or = 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 > or = 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 > or = 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%.
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.
MEDIA CONTACTS:
Biogen Idec
Shannon Altimari, 617-914-6524
or
Elan
Jonathan Birt, 212-850-5664
+44 20 7269 7205
or
Niamh Lyons, +353 1 663 3602
or
INVESTOR CONTACTS:
Biogen Idec
Eric Hoffman, 617-679-2812
or
Elan
Chris Burns, + 353 1 709 4444
800-252-3526
or
David Marshall, +353 1 709 4444
|