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Elan’s near term funding obligations to Janssen AI expected to
decrease
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Elan to write down its equity method investment in Janssen AI
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Elan focused on Tysabri growth and continued financial strengthening
DUBLIN--(BUSINESS WIRE)--Aug. 6, 2012--
Elan Corporation, plc (NYSE:ELN) announced today that Johnson & Johnson
has issued a press release regarding the discontinuation of Phase 3
development of bapineuzumab IV in mild to moderate Alzheimer’s. The
press release can be accessed on http://www.janimm.com/news/press
or http://www.jnj.com/connect/news/.
Additionally, Pfizer Inc. has provided an announcement to the
marketplace on the top line results of Phase 3 Study 301. The press
release can be accessed on http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp.
“We are tremendously disappointed for patients and their caregivers who
are suffering from Alzheimer’s and our employees who have dedicated many
years to advancing this technology with the goal of creating a
meaningful therapy to combat this challenging disease,” said Kelly
Martin, CEO of Elan Corporation, plc. He commented further that, “from a
shareholder perspective, we will continue to focus on revenue growth
with the advancement of Tysabri, rigorous cost and timeline alignment
and – as we have done consistently over the years - a strengthening of
our balance sheet and capital structure to provide a unique growth and
value investment thesis to the marketplace while continuously reducing
overall financial risk.”
Specific details surrounding the anticipated reduction of Janssen AI’s
future funding requirements will be determined after discussions with
our equity co-investor, Johnson & Johnson and after the complete data
set from Study 301 and 302 has been presented at the 16th
Congress of the European Federation of Neurological Societies (EFNS) on
September 11, 2012, the American Neurological Association (ANA) Annual
Meeting on October 8, 2012 and the 5th Clinical Trials on
Alzheimer’s Disease (CTAD) on October 29, 2012. In addition to the data
from Study 301 and 302, outcomes from the on-going vaccine and
bapineuzumab SQ trials are important and will be instructive for a
comprehensive evaluation of the immunotherapeutic approach to
Alzheimer’s.
Given the discontinuation of the bapinezumab IV clinical development
work in mild to moderate Alzheimer’s patients, we anticipate there to be
a significant reduction in spending through the end of next year. In
addition, Elan will record a non-cash impairment charge of $117.3
million on our equity method investment in Janssen AI in the third
quarter of 2012, representing the full carrying value of Elan’s 49.9%
proportionate share of the Janssen AI AIP assets.
In September 2009, as a result of its transaction with Johnson &
Johnson, Elan acquired a 49.9% interest in Janssen AI. Janssen AI
partners with Pfizer, Inc on all operational aspects of the
immunotherapeutic platform including bapineuzumab. Elan owns 25% of the
AIP asset on a global basis plus certain royalty streams at various
revenue levels should any therapy from AIP be commercialized in the
future.
About Elan
Elan 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. For additional
information about Elan, please visit http://www.elan.com.
Forward Looking Statements
This document contains forward-looking statements about Elan’s
financial condition, results of operations, business prospects and
products in research and development 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 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 discovery, development and
commercialization of additional products; 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 research and development activities, and research and
development activities in which we retain an interest, including, in
particular, whether the Phase 3 clinical trials for bapineuzumab are
successful (Pfizer announced on July 23rd that
the co-primary clinical endpoints were not met in one of the
bapineuzumab Phase 3 clinical trials and that participants from that
clinical trial who enrolled in a follow-on extension study will no
longer receive doses of bapineuzumab; Johnson & Jonson announced on
August 6, 2012 that it was discontinuing development of bapineuzumab IV
in mild to moderate Alzheimer’s disease) and the speed with which
regulatory authorizations and product launches may be achieved; our
dependence on Johnson & Johnson and Pfizer for the success of AIP; we
own approximately six percent of Alkermes plc and our shares are subject
to legal and contractual transfer restrictions; 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; 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:
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