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
commercially; and
-- In global clinical trials, approximately 1,000 patients are on
TYSABRI therapy.
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, Elan.
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 ongoing
basis.
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.
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 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.
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. 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.