-
Migrate From The Current 50:50 Business Collaboration To A New
Structure
-
Upfront Payment Of $3.25 Billion Plus Double Digit Tiered Royalty
For Complete Asset
-
Tax Efficient Transaction
-
Simplified Structure Enables Improved Alignment Of Therapy To
Patients
-
Provides Capital And Long Term Cash Flow For Investment, Growth And
Business Diversification
DUBLIN--(BUSINESS WIRE)--Feb. 6, 2013--
Elan Corporation, plc (NYSE:ELN) today announced that it has agreed to
restructure the Tysabri® collaboration with Biogen Idec. Under the terms
of the agreement, Elan will move from the current 50:50 business
collaboration to an upfront payment of $3.25 billion and a double digit
tiered royalty structure for the complete asset.
Highlights of Transaction Upon Closing:
-
Up front cash payment of $3.25 billion to Elan
-
First 12 months: royalty of 12% of Tysabri global net sales (all
indications)
-
Tiered royalty structure after 12 months
-
18% on up to $2 billion of global net sales (all indications)
-
25% on over $2 billion of global net sales (all indications)
-
Biogen Idec will have full ownership and control of Tysabri
-
Current 50:50 collaboration will terminate
-
Provides tax efficient capital and long term cash flow to Elan
Elan’s CEO, Kelly Martin, commented “This transaction enables Elan and
its shareholders to realize, upon close, a meaningful percentage of the
current value of Tysabri while maintaining long term cash flow
realization through the multi-tiered royalty structure of the complete
asset.
Mr. Martin added, “The restructuring of this business collaboration
provides Elan with significant strategic flexibility. Future actions
will be guided by our consistent and multi-year approach of dynamic
risk/reward assessment of business opportunities. We are enthusiastic
about the market opportunities around the globe and remain flexible and
creative about the manner in which we would participate in those
opportunities.”
“Upon close, this highly unique platform provides us with the financial
resources to create an enterprise that will diversify its assets,
generate future income, maintain specific science and clinical
translational capabilities, and leverage the financial and business
structure from being a 40 year Irish plc.”
“Our motivation was to diversify and de-risk the company to move
forward; and for the patients to continue to benefit from the profound
efficacy of Tysabri. The risk of one asset and a single collaborator was
not ideal”.
Mr. Martin concluded, “Over the past twelve years, Biogen Idec has been
a terrific collaborator. I would like to personally thank them for their
professionalism, sincere focus on patient care and our corporate
relationship overall. As we move into the future, we look forward to
participating in Tysabri’s success over the intermediate and long term
as it continues to provide benefit to patients who suffer from relapsing
remitting MS. Additional life cycle opportunities in secondary
progressive MS and/or other non-MS indications may represent further
advancements for patient choice and broad utilization of this unique
therapeutic asset.”
Conditions
The transaction has been approved by the boards of directors of both
companies and is subject to the customary review process under the
Hart-Scott-Rodino Antitrust Improvements Act in the United States, other
customary review processes and closing conditions. The transaction is
expected to close by the end of the second quarter 2013.
Advisors
Citi and Ondra Partners are acting as financial advisors to Elan.
Cadwalader, Wickersham & Taft LLP and A&L Goodbody are acting as legal
counsel to Elan.
Webcast
Elan are hosting a webcast to discuss full -year 2012 financial results
today, February 6, 2013 at 8.30am EST/1.30pm GMT and the Tysabri
restructuring transaction will be discussed during the call. Live audio
of the conference call will be simultaneously broadcast over the
Internet and will be available to investors, members of the news media
and the general public. This event can be accessed by visiting Elan’s
website at www.elan.com
and clicking on the Investor Relations section, then on the event icon.
Following the live webcast, an archived version of the call will be
available at the same URL.
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 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 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 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.
About Elan
Elan is a biotechnology company, headquartered in Ireland, 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. For
additional information about Elan, please visit http://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.
Forward Looking Statements
This document contains forward-looking statements about Elan’s
financial condition, results of operations, business prospects and
Tysabri that involve substantial risks and uncertainties. You can
identify these statements by the fact that they use words such as
“anticipate”, “estimate”, “project”, “target”, “intend”, “plan”, “will”,
“believe”, “expect” and other words and terms of similar meaning in
connection with any discussion of future operating or financial
performance or events. Among the factors that could cause actual
results to differ materially from those described or projected herein
are the following: the risk that the Tysabri transaction does not
complete, the potential of Tysabri, which may be severely constrained by
increases in the incidence of serious adverse events (including death)
associated with Tysabri (in particular, by increases in the incidence
rate for cases of PML), or by competition from existing or new therapies
(in particular, oral therapies), and the potential for the successful
development and commercialization of additional products, whether
internally or by acquisition, especially given the separation of the
Prothena business which left us with no material pre-clinical research
programs or capabilities; Elan’s ability to maintain sufficient cash,
liquid resources, and investments and other assets capable of being
monetized to meet its liquidity requirements; the success of our
development activities, and research and development activities in which
we retain an interest, including, in particular, the impact of the
announced discontinuation of the development of bapineuzumab intravenous
in mild to moderate Alzheimer’s disease; failure to comply with
anti-kickback, bribery and false claims laws in the United States,
Europe and elsewhere; difficulties or delays in manufacturing and
supply of Tysabri; trade buying patterns; the impact of potential
biosimilar competition, whether restrictive covenants in Elan’s debt
obligations will adversely affect Elan; the trend towards managed care
and health care cost containment, including Medicare and Medicaid;
legislation and other developments affecting pharmaceutical pricing and
reimbursement (including, in particular, the dispute in Italy with
respect to Tysabri sales), both domestically and internationally;
failure to comply with Elan’s payment obligations under Medicaid and
other governmental programs; exposure to product liability (including,
in particular, with respect to Tysabri) and other types of lawsuits and
legal defense costs and the risks of adverse decisions or settlements
related to product liability, patent protection, securities class
actions, governmental investigations and other legal proceedings; Elan’s
ability to protect its patents and other intellectual property; claims
and concerns that may arise regarding the safety or efficacy of Elan’s
products or product candidates; interest rate and foreign currency
exchange rate fluctuations and the risk of a partial or total collapse
of the euro; governmental laws and regulations affecting domestic and
foreign operations, including tax obligations; if the Tysabri
transaction completes, whether we are deemed to be an Investment Company
or a Passive Foreign Investment Company; general changes in United
States and International generally accepted accounting principles;
growth in costs and expenses; and the impact of acquisitions,
divestitures, restructurings, product withdrawals and other unusual
items. A further list and description of these risks, uncertainties and
other matters can be found in Elan’s Annual Report on Form 20-F for the
fiscal year ended December 31, 2011, and in its Reports of Foreign
Issuer on Form 6-K filed with the SEC. Elan assumes no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Source: Elan Corporation, plc
Elan Corporation, plc
Investor Relations:
Chris
Burns, 800-252-3526
or
David Marshall, + 353-1-709-4444
or
Media
Relations:
Emer Reynolds, + 353-1-709-4022
or
Jonathan
Birt, +44-751-559-7858
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