02.07.2007 23:01:00
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TYSABRI(R) Recommended by NICE for Use in Highly Active Relapsing Remitting Multiple Sclerosis in the Final Appraisal Determination
Biogen Idec (NASDAQ: BIIB) and Elan Corporation (NYSE: ELN) welcome today’s
announcement by the National Institute for Health and Clinical
Excellence (NICE) in the final appraisal determination which recommended
use of TYSABRI®
(natalizumab) in people with highly active relapsing remitting multiple
sclerosis (RRMS). TYSABRI is the first treatment for multiple sclerosis
to be recommended for use by NICE.
"This decision offers people with highly
active relapsing remitting multiple sclerosis hope of regaining control
of their disease,” commented Professor Gavin
Giovannoni, The Royal London Hospital. "TYSABRI
represents a significant advance in MS treatment, offering real hope of
delaying the progression of disability and reducing the frequency of
relapses.”
Highly active RRMS (defined as two or more disabling relapses in one
year and an active MRI scan) has a devastating effect on the lives of
the individual and their families. These patients experience more
relapses and will become disabled more quickly than those people with
typical RRMS. This inevitably means that they will not be able to enjoy
an active life combined with the strong probability that they, and the
family members who care for them, will be unable to work. In these
patients, MS progresses twice as quickly as those with less active forms
of the disease.
TYSABRI is the first treatment to be specifically licensed for highly
active RRMS. Over two years, treatment with TYSABRI leads to a 68%
relative reduction in clinical relapses and a 54% relative reduction in
the risk of sustained disability progression compared with placebo.
Hans Peter Hasler, Head of Biogen Idec International, added, "Multiple
sclerosis can be a devastating condition if not treated appropriately,
and we are very pleased that NICE has recommended in the final appraisal
determination that patients with highly active relapsing remitting
multiple sclerosis should have access to treatments like TYSABRI. With
successful treatment with TYSABRI, highly active relapsing remitting
multiple sclerosis patients are more likely to be able to continue to
work, maintain active social lives, and spend quality time with their
families.” "TYSABRI is the first treatment to be
recommended for use by NICE, a significant milestone for patients
suffering from MS. This final appraisal firmly supports patients and
their physicians having access to TYSABRI with its compelling benefits
in the treatment of MS,” said Dr. Menghis
Bairu, SVP, Head of Elan International.
As of late May, TYSABRI is already offering hope to approximately 12,000
patients on therapy in both commercial use and clinical trials in the
US, Germany, France, Ireland and many other countries.
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
that are subject to risks and uncertainties that could cause actual
results to differ materially from that which we expect. Important
factors that could cause our actual results to differ include the
possibility that our competitors may offer treatment options that gain
greater acceptance than TYSABRI, regulatory and safety risks of TYSABRI,
and the other risks and uncertainties that are described in the periodic
and current reports that Biogen Idec and Elan have filed with the
Securities and Exchange Commission, including the "Risk Factors"
sections of such filings. These forward looking statements speak only as
of the date of this press release, and the companies do not undertake
any obligation to update any forward looking statements, whether as a
result of new information, future events, or otherwise.
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