Biogen Idec Completes Purchase of Full Rights and Control of TYSABRI®
WESTON, Mass. -- April 2, 2013
Biogen Idec (NASDAQ: BIIB) today announced it has completed its purchase of
Elan Corporation’s interest in TYSABRI^® (natalizumab) and has gained full
strategic, commercial and decision-making rights to TYSABRI. The transaction
was originally announced on February 6, 2013.
“Full ownership of TYSABRI is an important step for Biogen Idec that further
solidifies our leadership in MS,” said George A. Scangos, Ph.D., chief
executive officer of Biogen Idec. “The powerful efficacy of TYSABRI makes it
an important treatment for many people living with MS and we believe it has a
solid growth trajectory for years to come. We are grateful to Elan for more
than a decade of collaboration on TYSABRI, and for their work to provide a
seamless transition as we finalized the transaction.”
Further details and updated financial guidance will be provided during Biogen
Idec’s upcoming first quarter 2013 earnings announcement.
For more than two decades Biogen Idec has been a leader in multiple sclerosis
(MS), offering a wide range of therapies, unsurpassed patient support, and a
robust R&D program toimprove the lives of people withMS.Biogen Idec also
has the deepest MS pipeline in the industry with compounds that include
PLEGRIDY™ (peginterferon beta-1a);daclizumab high-yield process (DAC HYP) for
monthly subcutaneous administration; and an ongoing study withTYSABRI as a
treatment for secondary progressive multiple sclerosis (SPMS).
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 due to the risk of progressive multifocal
leukoencephalopathy (PML). In the European Union, it is approved for highly
active relapsing-remitting MS (RRMS) in adult patients who have failed to
respond to beta interferon or have rapidly evolving, severe RRMS.
TYSABRI has advanced the treatment of MS patients 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 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 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.
As a result of the acquisition from Elan, TYSABRI will be marketed and
distributed solely by Biogen Idec. For full prescribing information and more
information about TYSABRI, please visit www.biogenidec.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 $5 billion in annual
revenues. For product labeling, press releases and additional information
about the company, please visit www.biogenidec.com.
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’s shares
trade on the New York and Irish Stock Exchanges. For additional information
about Elan, please visit www.elan.com.
Biogen Idec Safe Harbor Statement
This press release contains forward-looking statements, including statements
about TYSABRI’s growth prospects. These forward-looking statements may be
accompanied by such words as “anticipate,” “believe,” “could,” “estimate,”
“expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,”
“target,” “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 our dependence on our three principal products, AVONEX^® (interferon
beta-1a), TYSABRI and RITUXAN^® (rituximab), the importance of TYSABRI’s sales
growth, uncertainty of success in commercializing and developing other
products, product competition, the occurrence of adverse safety events with
our products, changes in 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, our ability to protect our intellectual property rights and have
sufficient rights to market our products together with the cost of doing so,
the risks of doing business internationally, failure to manage our growth and
execute our growth initiatives, our ability to attract and retain qualified
personnel, product liability claims, 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.
Biogen Idec Media Contact:
Lindsey Smith, 781-464-3260
Senior Manager, Public Affairs
Daniel McIntyre, 781-464-3260
Senior Vice President, Public Affairs
Biogen Idec Investor Contacts:
Ben Strain, 781-464-2442
Senior Manager, Investor Relations
Claudine Prowse, Ph.D., 781-464-2442
Vice President, Investor Relations
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