Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in anti-JCV Antibody Negative Patients with MS

  Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in
  anti-JCV Antibody Negative Patients with MS

       - Marketing Applications Supported by Risk Stratification Data -

Business Wire

WESTON, Mass. & DUBLIN -- January 16, 2013

Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN)
announced that they have submitted applications to the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) requesting updates to
the TYSABRI^® (natalizumab) labels. The applications request an expanded
indication that would include first-line use for people living with certain
relapsing forms of multiple sclerosis (MS) who have tested negative for
antibodies to the JC virus (JCV). A formal assessment of both applications is

These submissions are supported by risk stratification data and a risk
algorithm that enables physicians and individuals living with MS to make
informed decisions when considering treatment with TYSABRI. If approved, a
first-line label will allow all appropriate anti-JCV antibody negative
patients to consider TYSABRI early in the course of treatment, regardless of
the level of disease activity or prior treatment history. TYSABRI is a highly
efficacious treatment that has been shown to slow disability progression by 42
– 54 percent and reduce annualized relapse rates by 68 percent.

“Our anti-JCV antibody test, STRATIFY JCV^®, helps to determine the most
appropriate patients for TYSABRI and the data collected to date supports our
recent filing for first-line use,” said Alfred Sandrock, M.D., Ph.D., senior
vice president, Development Sciences and Chief Medical Officer, Biogen Idec.
“Many appropriate patients are already benefiting from TYSABRI. A first line
approval would allow people with MS access to a highly efficacious treatment
earlier in the course of the disease, potentially leading to better outcomes.
This is an important consideration for people with MS who may want or need
more efficacy.”

Currently in the U.S., due to an increased risk of an opportunistic viral
infection, progressive multifocal leukoencephalopathy (PML), TYSABRI is
generally recommended for people living with relapsing forms of MS whose
disease is not responding to, or who are unable to tolerate, an alternative
therapy regardless of JCV status. In the EU, TYSABRI is approved for highly
active relapsing-remitting MS (RRMS) in adult patients who have failed to
respond to beta interferons or have rapidly evolving, severe RRMS.

“TYSABRI is an important treatment option for thousands of people living with
MS,” said Hans Peter Hasler, chief operating officer, Elan Corporation, plc.
“We are excited about these filings and the potential to make TYSABRI
available as a treatment option for more individuals early in the course of
their disease.”

TYSABRI is approved in more than 65 countries. TYSABRI is approved in the
United States as a monotherapy for relapsing forms of MS, generally for
patients who have had an inadequate response to, or are unable to tolerate, an
alternative MS therapy. In the European Union, it is approved for highly
active relapsing-remitting MS (RRMS) in adult patients who have failed to
respond to beta interferons or have rapidly evolving, severe RRMS.

TYSABRI has advanced the treatment of MS with its established efficacy. Data
from the Phase 3 AFFIRM trial, which was published in the New England Journal
of Medicine, showed that after two years, TYSABRI treatment led to a 68
percent relative reduction (p<0.001) in the annualized relapse rate when
compared with placebo and reduced the relative risk of disability progression
by 42-54 percent (p<0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy
(PML), an opportunistic viral infection of the brain which usually leads to
death or severe disability. Infection by the JC virus (JCV) is required for
the development of PML and patients who are anti-JCV antibody positive have a
higher risk of developing PML. Factors that increase the risk of PML are the
presence of anti-JCV antibodies, prior immunosuppressant use, and longer
TYSABRI treatment duration. Patients who have all three risk factors have the
highest risk of developing PML. Other serious adverse events that have
occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g.,
anaphylaxis) and infections, including opportunistic and other atypical
infections. Clinically significant liver injury has also been reported in the
post-marketing setting. A list of adverse events can be found in the full
TYSABRI product labeling for each country where it is approved.

TYSABRI is marketed and distributed by Biogen Idec Inc. and Elan Corporation,
plc. For full prescribing information and more information about TYSABRI,
please visit or

About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture and
market therapies for serious diseases with a focus on neurology, immunology
and hemophilia. Founded in 1978, Biogen Idec is the world's oldest independent
biotechnology company. Patients worldwide benefit from its leading multiple
sclerosis therapies and the company generates more than $4 billion in annual
revenues. For product labeling, press releases and additional information
about the company, please visit

About Elan
Elan Corporation, plc is a neuroscience-focused 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 and Irish Stock Exchanges. For additional information about
Elan, please visit

Safe Harbor
This press release includes forward-looking statements, including statements
about regulatory actions and the development and commercialization of TYSABRI
in MS. These forward-looking statements may be accompanied by such words as
"anticipate," "believe," "estimate," "expect," "forecast," "intend," "may,"
"plan," "will," and other words and terms of similar meaning. You should not
place undue reliance on these statements. These statements involve risks and
uncertainties that could cause actual results to differ materially from those
reflected in such statements, including obtaining regulatory approval, the
occurrence of adverse safety events, product competition, the availability of
reimbursement for our products, adverse market and economic conditions,
problems with our manufacturing processes and our reliance on third parties,
failure to comply with government regulation and possible adverse impact of
changes in such regulation, our ability to protect our intellectual property
rights and the cost of doing so, and the other risks and uncertainties that
are described in the Risk Factors section of our most recent annual or
quarterly report and in other reports we have filed with the SEC. These
statements are based on our current beliefs and expectations and speak only as
of the date of this press release. We do not undertake any obligation to
publicly update any forward-looking statements.


Biogen Idec
Lindsey Smith, 781-464-3260
Emer Reynolds, +353-1-709-4022
Jonathan Birt, +44-751-559-7858
Biogen Idec
Kia Khaleghpour, 781-464-2067
Chris Burns, 1-800-252-3526
David Marshall, +353-1-709-4444
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