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

Wed Jan 16, 2013 2:00am EST

* Reuters is not responsible for the content in this press release.

http://pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130116:nBw156428a

- Marketing Applications Supported by Risk Stratification Data -
WESTON, Mass. & DUBLIN--(Business Wire)--
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 ongoing. 

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." 

About TYSABRI

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 www.biogenidec.com or www.elan.com. 

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
www.biogenidec.com. 

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
www.elan.com. 

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. 

###

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



Copyright Business Wire 2013