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This excerpt taken from the ELN 6-K filed Apr 23, 2009. Transition Therapeutics Inc.
(TSX: TTH, NASDAQ:TTHI) today announced the United States Patent and
Trademark Office issued US patent number 7,521,481 on April 21,
2009. The patent is entitled “Methods of Preventing, Treating
and Diagnosing Disorders of Protein Aggregation,” and generally claims methods
for treating Alzheimer’s disease comprising administering scyllo-inositol
(ELND005). The patent will expire in the year 2025 or later due to
any patent term extensions.
“The
issuance of this patent is an important milestone in the development of ELND005,
a unique oral compound with a favourable safety profile that crosses the
blood-brain barrier and targets the disaggregation of amyloid beta in the
brain,” said Dr. Tony Cruz, Chairman and Chief Executive Officer of
Transition.
In 2006,
Elan and Transition entered into an exclusive, worldwide collaboration agreement
for the joint development and commercialization of ELND005 for the treatment of
Alzheimer’s disease and other indications.
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.
ELND005
is currently in a Phase 2 clinical study. 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.
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
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 and 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
scyllo-inositol (ELND005) 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 ELND005 are not predictive of results to be obtained
in Phase 2 or later clinical trials, the patent issued 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 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.
Source: Elan
Corporation, plc and Transition Therapeutics
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