Elan and Transition Therapeutics Dose First Patient in Phase 2 Clinical Study of ELND005 (AZD-103) in Alzheimer's Disease



    DUBLIN, IRELAND & TORONTO, December 21 /CNW/ - Elan Corporation, plc
(NYSE:   ELN) and Transition Therapeutics Inc. (NASDAQ:   TTHI, TSX: TTH) today
announced that the first patient has been dosed in a Phase 2 clinical study of
ELND005 (AZD-103) in patients with Alzheimer's disease. The study is a
randomized, double-blind, placebo-controlled, dose-ranging, safety and
efficacy study in approximately 340 patients with mild to moderate Alzheimer's
disease. Approximately 65 sites in North America are expected to participate
in the program.

    The study will evaluate both cognitive and functional endpoints, and each
patient's participation is planned to last approximately 18 months.

    For information on enrollment, patients or caregivers should contact
clinical sites participating in the study directly. Participating sites can be
found by calling +1 877-687-8839. As sites become active, their details also
can be found by visiting www.clinicaltrials.gov.

    About ELND005 (AZD-103)

    ELND005 is an orally-administered therapeutic agent that has received
fast track designation from the U.S. Food and Drug Administration (FDA) for
treatment of mild to moderate Alzheimer's disease. Fast track designation
facilitates development and may expedite regulatory review of drugs that the
FDA recognizes as potentially addressing an unmet medical need for serious or
life-threatening conditions.

    In multiple Phase 1 studies that evaluated the safety, tolerability and
pharmacokinetic profile of ELND005 in approximately 110 healthy volunteers,
ELND005 was safe and well-tolerated at all doses and dosing regimens examined.
No severe or serious adverse events were observed. Preclinical data suggest
that ELND005 may act through the unique mechanism of preventing and reversing
the fibrilization of beta-amyloid, a toxic peptide that forms plaques that are
a key pathological feature of Alzheimer's disease.

    About Alzheimer's Disease

    Alzheimer's disease, a leading cause of dementia, is a progressive brain
disorder that gradually destroys a person's memory and ability to learn,
reason, make judgments, communicate and carry out daily activities.
Alzheimer's disease may result from the build-up of toxic beta-amyloid
peptides in the brain. As Alzheimer's disease progresses, individuals may also
experience changes in personality and behavior, such as anxiety,
suspiciousness or agitation, as well as delusions or hallucinations. It is
currently estimated that more than 5 million Americans have Alzheimer's
disease and more than 24 million people worldwide over the age of 60 have some
form of dementia (Source: Alzheimer's Association and Alzheimer's Disease
International).

    About Elan

    Elan Corporation, plc is a neuroscience-based 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, London and Dublin Stock Exchanges. For additional information
about the company, please visit http://www.elan.com.

    About Transition Therapeutics Inc.

    Transition is a biopharmaceutical company, developing novel therapeutics
for disease indications with large markets. Transition's lead products include
ELND005/ AZD-103 for the treatment of Alzheimer's disease and TT-223 for the
treatment of diabetes. Transition has an emerging pipeline of preclinical drug
candidates acquired externally or developed internally using its proprietary
drug discovery engine. Transition's shares are listed on the NASDAQ under the
symbol "TTHI" and the Toronto Stock Exchange under the symbol "TTH". For
additional information about the Company, please visit
www.transitiontherapeutics.com.

    Safe Harbor / Forward-Looking Statements

    This press release contains forward-looking statements regarding the
development of ELND005 (AZD-103) under the collaboration agreement between
Elan and Transition. These statements are based on Elan's and Transition's
current beliefs and expectations. ELND005 may not be successfully developed or
commercialized under the collaboration agreement. Factors which could cause
actual results to differ materially from Elan's and Transition's current
expectations include the risks that clinical development of ELND005 fails due
to safety or efficacy issues, the results from Phase 1 clinical trials and
preclinical testing of ELN-005 are not predictive of results to be obtained in
Phase 2 or later clinical trials, that any patents will issue with respect to
ELND005 or that, even if issued, whether any such patents would provide
substantial protection or commercial benefit, the development and
commercialization of competitive therapies, the collaboration agreement is
terminated early or Elan and Transition encounter other unexpected delays or
hurdles. Drug development and commercialization involves a high degree of
risk. For more detailed information on the risks and uncertainties associated
with Elan and Transition's drug development and other activities, see the
periodic and current reports that Elan has filed with the Securities and
Exchange Commission and that Transition has filed with the Securities and
Exchange Commission and the Ontario Securities Commission. Elan and Transition
assume no obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.




For further information:

For further information: Elan Corporation, plc: Media: Jonathan Birt,
212-850-5664 or Elizabeth Headon, 353-1-498-0300 or Investors: Chris Burns,
800-252-3526 353-1-709-4444 or Transition Therapeutics Inc.: Dr. Tony Cruz,
416-260-7770 ext. 223 or Elie Farah, 416-260-7770 ext. 203

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