|
|
 | | | |
- close
- close
- close
- close
| |||||||||
This excerpt taken from the ELN 6-K filed Apr 16, 2008. Chicago, IL – April 16, 2008 –
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced
additional findings from the PLEX study which shows that plasma exchange
accelerates the removal of TYSABRI®
(natalizumab) from blood serum in patients and may help improve central nervous
system immune response based on an in vitro
model. The data was presented today at the 60th Annual
Meeting of the American Academy of Neurology (AAN). Plasma exchange
is one of several research efforts the companies have underway to learn more
about potential interventions or treatments for progressive multifocal
leukoencephalopathy (PML).
“The goal
of these studies is to evaluate the value of plasma exchange in patients who may
develop PML. The data are encouraging as they show that removal of
TYSABRI through plasma exchange may be a potential intervention to rapidly clear
TYSABRI and restore immune function when clinically appropriate,” said the
study’s lead author, Bhupendra O. Khatri, MD, Medical Director of the Regional
MS Center, Aurora St. Luke’s Medical Center, Milwaukee, WI.
PLEX is
an open-label, single-arm, multicenter exploratory study involving 12 patients
with relapsing-remitting multiple sclerosis (MS), designed to explore whether
plasma exchange could significantly reduce the concentration of TYSABRI in blood
serum and alpha 4-integrin receptor saturation. Plasma
exchange is an established method of removing large molecules from the body’s
blood circulation. Based on the PLEX findings, plasma exchange was
effective at accelerating the normal decline of TYSABRI serum
concentrations.
A
sub-study of PLEX, also presented today at the meeting, evaluated the effect of
plasma exchange on the migration of certain immune cells, called leukocytes,
across an in vitro
model of the blood-brain barrier. TYSABRI was shown to reduce the
migration of these cells across the blood-brain barrier. The results
showed that plasma exchange improved the ability of these cells to migrate
across the blood brain barrier, potentially reestablishing normal central
nervous system immune response.
Plasma
exchange was generally well tolerated with no increase in MS disease
activity. There were no study discontinuations due to adverse events
and all patients returned to TYSABRI treatment without
complications. While further studies are being conducted, plasma
exchange has been shown to hold potential as an intervention in the setting of
PML.
Abstracts
from the larger PLEX study, “Plasma Exchange Accelerates the Decline of Serum
Natalizumab Concentration in Patients with Multiple Sclerosis: Results of the
Natalizumab PLEX Study” (Presentation #S22.005) and the sub-analysis, “Plasma
Exchange Augments Leukocyte Transmigration Across an In Vitro Blood-Brain Barrier
In Natalizumab-Treated Patients with Multiple Sclerosis” (Presentation #S27.005)
are available on-line at the AAN’s website.
About
TYSABRI
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<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 recently approved 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.
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 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 30 countries including the United States and many
countries throughout the European Union, as well as Switzerland, Canada,
Australia, New Zealand and Israel.
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.
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.
Safe
Harbor/Forward-Looking Statements
This
press release contains forward-looking statements regarding TYSABRI and the PLEX
study. 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.
###
|