CAMBRIDGE, MASS. & DUBLIN, October 11 /CNW/ - Biogen Idec (NASDAQ: BIIB)
and Elan Corporation, plc (NYSE: ELN) today announced new data on the global
utilization and safety of TYSABRI(R) (natalizumab), citing that as of the end
of September 2007 approximately 17,000 patients are on commercial and clinical
therapy worldwide, and that the safety data to date continue to support a
favorable benefit-risk profile for TYSABRI. These data will be presented as
part of the companies' symposia being held on Friday, October 12, 2007 at 6
p.m. CEST at the 23rd Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.
As of the end of September 2007:
-- In the US, approximately 10,500 patients are on TYSABRI commercially
and over 2,100 physicians have prescribed the therapy;
-- In the EU, approximately 5,500 patients are on TYSABRI therapy
-- In global clinical trials, approximately 1,000 patients are on
TYSABRI is available in the United States through the TOUCH(TM)
Prescribing Program. All prescribers, infusion sites and patients receiving
TYSABRI are required to enroll in TOUCH. Safety information is also collected
through ongoing clinical trials and registries, including TYGRIS and the
pregnancy registry, making this the largest long-term patient follow-up effort
undertaken for any MS therapy.
According to data available to the companies as of mid-September 2007,
there have been no new reports of confirmed cases of progressive multifocal
leukoencephalopathy (PML). The safety data to date continue to support a
favorable benefit-risk profile for TYSABRI. The companies plan to continue to
provide similar updates at future medical meetings.
"Neurologists and patients are increasingly choosing TYSABRI given its
significant impact on clinically meaningful and relevant endpoints, including
relapses and disability progression. Ultimately, we believe the full potential
of TYSABRI will be realized, making it the leading MS therapy," said Michael
Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology
Strategic Business Unit, Biogen Idec.
"Continued patient experience and ongoing clinical research will further
differentiate TYSABRI as a valuable treatment option for MS patients around
the world. TYSABRI is currently approved in more than 20 countries, and we
hope to offer this therapeutic alternative to more patients in the future,"
said Gordon Francis, MD, Senior Vice President, Global Clinical Development,
About TOUCH and TYGRIS
Before initiating treatment, all US patients, prescribers and infusion
sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach:
Unified Commitment to Health). TOUCH is designed to determine the incidence of
and risk factors for serious opportunistic infections (OIs), including PML,
and to monitor patients for signs and symptoms of PML while promoting informed
benefit-risk discussions prior to initiating TYSABRI treatment. Physicians
report on PML, serious OIs, deaths and discontinuation of therapy on an
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to
enroll 5,000 patients worldwide, including approximately 3,000 patients from
TOUCH. Patients in TYGRIS are evaluated at baseline and every six months
thereafter for five years. Researchers will evaluate data including medical/MS
history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or
immunosuppressive agents; and all serious adverse events, including PML and
other serious OIs, and malignancies.
Adverse event reporting in the post-marketing setting is voluntary. It is
possible that not all reactions have been reported, or that some reactions are
not reported to Biogen Idec or Elan in a timely manner.
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.
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 Amy Reilly,
617-914-6524 or Elan Jonathan Birt, 212-850-5664 or 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