DUBLIN, IRELAND & CAMBRIDGE, MASS., October 15 /CNW/ - Elan Corporation,
plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced that the U.S.
Food and Drug Administration (FDA) informed the companies that the Agency will
extend its regulatory review of TYSABRI(R) (natalizumab) as a treatment for
Crohn's disease by up to 3 months.
The companies have been informed by the FDA that the Agency requires
additional time to review information regarding the proposed TYSABRI risk
management plan for Crohn's disease. Under this revised timeline, the
companies anticipate action from FDA on or before January 13, 2008.
About Crohn's Disease
Approximately one million people worldwide have Crohn's disease, a
chronic and progressive inflammatory disease of the gastrointestinal tract,
which commonly affects both men and women.
The disease usually causes diarrhea and crampy abdominal pain, often
associated with fever, and at times rectal bleeding. Loss of appetite and
weight loss also may occur. Complications include narrowing of the intestine,
obstruction, abscesses, and fistulas (abnormal channels connecting the
intestine and other organs, including the skin), and malnutrition. Most
patients eventually require surgery, which has both risks and potential short-
and long-term complications.
Crohn's disease can have a devastating impact on the lifestyle of
patients, many of whom are young and active. Currently there is no medical or
surgical cure for Crohn's disease. Many patients fail to respond to current
therapies, including biological therapies such as agents that inhibit tumor
necrosis factor alpha (TNF-alpha). Due to this failure of current therapies in
CD, therapies that have novel biological targets are required.
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 for MS 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.
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.
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.
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: Biogen Idec Amy Reilly, 617-914-6524 or
Elan Jonathan Birt, 212-850-5664 or Elizabeth Headon, 353 1 498 0300 or
INVESTOR: Biogen Idec Eric Hoffman, 617-679-2812 or Elan Chris Burns, 353 1
709 4444 800-252-3526