Elan Corporation, plc (NYSE: ELN) today provides an update on
ELND005 (Scyllo-inositol).
Elan has entered into a manufacturing agreement for the supply of the
active pharmaceutical ingredient for ELND005 with Lonza Group AG. This
agreement is fundamental to ensuring that a high quality supply of
ELND005 will be available to support the advancement of the program.
During the 4th Conference Clinical Trials on
Alzheimer’s Disease (CTAD), held in November 2011, ELND005 was
featured during four oral presentations and on two posters where new
analyses were presented from the Phase II Alzheimer’s disease study
(AD201, Salloway et al. Neurology 2011) by globally recognized
Alzheimer’s disease experts. The presentations focused on treatment
effects at earlier stages of the disease, using validated "composite”
cognitive endpoints. These results support the general direction of the
field for earlier intervention.
In addition, data on ELND005’s role in reducing the emergence of
neuropsychiatric symptoms in Alzheimer’s patients was highlighted.
ELND005 may have applications in additional psychiatric indications such
as bipolar. Elan’s goal is to initiate a proof of concept, Phase II
study in bipolar disorder post completion of discussions with
therapeutic experts and regulators.
For earlier stages of Alzheimer’s disease, experts and regulators
continue to evolve their understanding of the disease from a biological,
clinical and biomarker perspective. Elan will continue to seek advice as
it advances the ELND005 program in Alzheimer’s disease.
Further updates will be provided as appropriate.
Notes to Editors:
ELND005:
In December 2010, Elan modified its Collaboration Agreement with
Transition Therapeutics Inc. (Transition). As a consequence of
Transition's decision to exercise its opt-out right, Transition is not
funding any continuing development or commercialization of ELND005 and
has also relinquished its 30% ownership of ELND005 to Elan. Elan has
until December 2012 to advance the asset in clinical trials or Elan must
terminate the collaboration agreement, unless Elan plays Transition $11
million by January 31, 2013.
Under the modified agreement, Elan paid Transition $9.0 million in
January 2011. Transition is still eligible to receive a further $11.0
million payment upon the commencement of the next ELND005 clinical trial
but will no longer be eligible to receive a $25.0 million milestone that
would have been due upon the commencement of a Phase 3 trial for
ELND005, under the terms of the original agreement.
Consistent with the terms of the original agreement, following its
opt-out decision, Transition will be entitled to receive milestone
payments of up to $93.0 million (in addition to the $11.0 million
described above), along with tiered royalty payments on net sales of
ELND005 ranging in percentage from a high single digit to the mid teens,
depending on level of sales.
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.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding the
development of scyllo-inositol (ELND005) under the collaboration
agreement between Elan and Transition. These statements are based on
Elan'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
current expectations include the risks that clinical development of
ELND005 fails due to safety or efficacy issues, Elan fails to receive
regulatory approval to undertake additional clinical trials, the results
from Phase 1 and 2 clinical trials and preclinical testing of ELND005
are not predictive of results to be obtained in
later clinical
trials, the patent with respect to ELND005 may not provide substantial
protection or commercial benefit, the development and commercialization
of competitive therapies, the collaboration agreement is terminated
early or Elan encounters other 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's drug development and other activities, see the
periodic and current reports that Elan has filed with the Securities and
Exchange Commission. Elan assumes no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
