CAMBRIDGE, MASS.& DUBLIN, IRELAND, August 20 /CNW/ - Biogen Idec (NASDAQ:
BIIB) and Elan Corporation, plc (NYSE: ELN) announced today the publication of
results demonstrating that patients treated with TYSABRI(R) (natalizumab)
showed a significant improvement in health-related quality-of-life (HRQoL)
measures when compared to placebo. These results are from the first Phase III
multiple sclerosis (MS) studies that have demonstrated improvement on HRQoL
measures in patients with relapsing forms of MS. The results have been
published in today's issue of Annals of Neurology.
"These data showed that patients treated with TYSABRI were more likely to
experience statistically important improvement in the quality-of-life measures
used to assess meaningful disease improvement or progression. These findings
have not been previously observed in clinical studies involving MS patients,"
said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis
Treatment and Research at the Cleveland Clinic, the lead investigator of the
These two-year, randomized, double-blind, placebo-controlled,
multicenter, Phase III clinical trials (AFFIRM and SENTINEL) were conducted in
2,113 patients with relapsing forms of MS. The objective was to assess the
relationship between disease activity and HRQoL in relapsing forms of MS, and
the impact of TYSABRI on these measures.
In the studies, HRQoL was assessed using two different measures at
baseline and weeks 24, 52 and 104:
-- The Short Form-36 (SF-36), a standardized, well-validated survey that
has been used extensively in many disease areas, including MS to review health
status. The SF-36 is comprised of 36 questions designed to assess physical
(Physical Component Summary or PCS) and mental (Mental Component Summary or
MCS) well-being from the perspective of the patient.
-- The Visual Analogue Scale (VAS), a measure of well-being as assessed
by the patient and marked on a scale of 0 to 100, with 0 indicating "poor" and
100 indicating "excellent."
Results from the AFFIRM monotherapy trial include:
-- A statistically significant improvement in SF-36 PCS beginning at
week 24 and all subsequent time points compared with a decline in the
-- A statistically significant improvement in SF-36 MCS at week 104
compared with a decline in the placebo-treated group.
-- Statistically significant benefits using the VAS when compared with
placebo at week 52 and at week 104.
-- Patients showed sustained improvement from baseline quality-of-life
measures, not just a slowing down of quality-of-life deterioration.
-- HRQoL measures correlated with common measures of MS severity,
including EDSS, sustained disability progression, relapse number, MSFC and
volume of T2-hyperintense and T1-hypointense lesions.
Improvements on quality-of-life measures were also observed in the
SENTINEL study, in which TYSABRI was added to AVONEX(R) (Interferon beta-1a).
This publication is in addition to a presentation of preliminary results from
the same study presented at the 2006 American Academy of Neurology Annual
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), infections, depression and gallstones. 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
Common adverse events reported in TYSABRI-treated patients include
headache, fatigue, infusion reactions, urinary tract infections, joint and
limb pain, lower respiratory infections, rash, gastroenteritis, abdominal
discomfort, vaginitis, and diarrhea.
In addition to the United States and European Union, TYSABRI is also
approved in Switzerland, Canada, Australia and Israel. TYSABRI was discovered
by Elan and is co-developed with Biogen Idec.
For more information about TYSABRI please visit www.tysabri.com,
www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
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.
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.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding TYSABRI.
These statements are based on the companies' current beliefs and expectations.
The commercial potential of TYSABRI is subject to a number of risks and
uncertainties. Factors which could cause actual results to differ materially
from the companies' current expectations include the risk that we may be
unable to adequately address concerns or questions raised by FDA or other
regulatory authorities, that concerns may arise from additional data, that the
incidence and/or risk of PML or other opportunistic infections in patients
treated with TYSABRI may be higher than observed in clinical trials, or that
the companies may encounter other unexpected hurdles. Drug development and
commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated
with the companies' drug development and other activities, see the periodic
and current reports that Biogen Idec and Elan have filed with the Securities
and Exchange Commission. The companies assume no obligation to 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 Elan Jonathan Birt, 212-850-5664 Elizabeth Headon, 353 1 498 0300
or INVESTOR CONTACTS: Biogen Idec Eric Hoffman, 617-679-2812 or Elan Chris
Burns, 353 1 709 4444 800-252-3526