) recently initiated a phase II study on ELND005 (Study AG201)
for the treatment of agitation/aggression in patients suffering
from moderate-to-severe Alzheimer's disease (AD).
The AG201 study will evaluate the efficacy, safety and
tolerability of ELND005 for a period of 12 weeks in patients
suffering from AD and experiencing at least moderate levels of
agitation/aggression. Elan will enroll around 400 patients for
the study in the US, Canada and other selected countries.
Elan stated in its press release that around 5.4 million
people in the US and around 7.2 million people in the EU are
suffering from AD. Almost 90% of AD patients develop
neuropsychiatric symptoms (NPS) and around 60% of AD patients
develop agitation/aggression. The company also stated that
currently there are no approved therapies for
agitation/aggression in the US and many other countries.
We note that companies like
Eli Lilly and Company
) are also looking to enter the Alzheimer's disease market.
ELND005 is also being developed as an adjunctive maintenance
treatment in patients suffering from bipolar I disorder (BPD 1)
to lengthen the time period between mood episodes. In August this
year, Elan initiated a phase II placebo-controlled, safety and
efficacy study with oral ELND005 for this indication.
In 2006, Elan had entered into an exclusive, worldwide
collaboration agreement with
Transition Therapeutics, Inc.
) to jointly develop and commercialize ELND005.
Elan and Transition Therapeutics modified their agreement in
2010, following which Transition Therapeutics stopped funding the
candidate's development and commercialization and has given up
its 30% ownership of the candidate to Elan. Elan paid Transition
Therapeutics $9.0 million in January 2011. However, Elan will no
longer be required to pay the previously stipulated $25 million
as a milestone payment on the commencement of the phase III study
The company made a one-time clinical milestone payment of $11
million to Transition Therapeutics for the first patient dosing
in the BPD 1 study.
We are pleased with the company's progress with ELND005.
We expect investor focus to stay on the successful development of
the candidate. We currently have a Neutral recommendation on
Elan. The stock carries a Zacks #3 Rank (Hold rating) in the
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