Cynapsus Therapeutics Receives Notice of Allowance from United States
Patent and Trademark Office (USPTO)
Claims Covering APL-130277 Apomorphine Sublingual Thin Film Strip for
TORONTO, ONTARIO -- (Marketwire) -- 12/11/12 --
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Cynapsus Therapeutics Inc. (TSX VENTURE:CTH) is a specialty
pharmaceutical company developing the only orally-administered
delivery form of apomorphine for the rescue of "off" episodes in
Parkinson's disease. The Company announced today that the United
States Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for the patent application 13/445,656 with critical claims
directed to thin film compositions containing apomorphine formulated
for sublingual administration. The allowed application will be the
first to emerge as a U.S. patent from the company's patent
application filings directed to sublingual apomorphine therapies.
Cynapsus' drug candidate, APL-130277, is an easy-to-administer,
fast-acting sublingual formulation of apomorphine for use in the
rescue of Parkinson's patients from "off" episodes in which the
patients have impaired movement or speaking capabilities. The allowed
claims cover APL-130277.
"We are very pleased that our intellectual property estate on our
sublingual apomorphine project is advancing nicely alongside
scientific, clinical and other business developments," said Anthony
Giovinazzo, President and Chief Executive Officer at Cynapsus. "The
issuance of the patent further strengthens our confidence that
APL-130277 will successfully reach the market in 2015."
"We are gratified that the USPTO has allowed these key composition
claims covering APL-130277," said Dr. Nathan Bryson, Chief Scientific
Officer of Cynapsus. "We are also grateful to have a strong team of
experts and partners who have been instrumental in helping us reach
this point in our development."
The Cynapsus sublingual apomorphine formulations, including
APL-130277, provide a sublingual, dual layer thin film strip system
with optimized functional features, including the following:
-- fast acting for quick relief of "off" symptoms in Parkinson's patients;
-- a simple solid dosage form with easy administration;
-- a dosage form that is fast-dissolving under the tongue for convenience;
-- comparable serum profile and therapeutic effects relative to apomorphine
injection without the use of a needle; and
-- near pH neutral formulation to reduce chances of possible irritation.
Cynapsus' intellectual property position includes other patent
applications that seek to further protect additional features of the
sublingual apomorphine therapy. Cynapsus has filed patent
applications in North America, Europe, Asia, and South America.
About Parkinson's Disease
Parkinson's disease is a chronic, degenerative neurological disorder
that results from the loss of dopamine-producing nerve cells in the
brain. Current treatments for Parkinson's disease are able to reduce
the symptoms of the disease but are not able to treat the underlying
neurodegenerative processes that lead to a decline in physical and
cognitive functions that affects some patients with Parkinson's
disease. It is estimated that over one million people in the United
States and 5 million people globally are living with Parkinson's
disease. According to the National Institute of Neurodegenerative
Disease and Stroke, the average age of onset is 60, although some
people are diagnosed at age 40 or younger.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing the only
non-injectable (i.e. sublingual) delivery of the only approved drug
(apomorphine) to be used as a rescue therapy for "off" motor symptoms
of Parkinson's disease. Over one million people in the U.S. and an
estimated 5 million people globally suffer from Parkinson's disease.
Parkinson's disease is a chronic and progressive neurodegenerative
disease that impacts motor activity, and its prevalence is increasing
with the aging of the population. Based on a recent study and the
results of the Company's Global 500 Neurologists Survey, it is
estimated that between 25 percent and 50 percent of patients
experience "off" episodes in which they have impaired movement or
speaking capabilities. Current medications only control the disease's
symptoms, and most drugs become less effective over time as the
Cynapsus' drug candidate, APL-130277, is an easy-to-administer,
fast-acting reformulation of apomorphine, which is approved in an
injection formulation to rescue patients from "off" episodes.
Cynapsus is focused on maximizing the value of APL-130277 by
completing pivotal studies in advance of a New Drug Application
expected to be submitted in 2015. Cynapsus anticipates a trade sale
or out-licensing to an appropriate global pharmaceutical partner
before such an application is submitted.
More information about Cynapsus (TSX VENTURE:CTH) is available at
www.cynapsus.ca and at the System for Electronic Document Analysis
and Retrieval (SEDAR) at www.sedar.com.
Forward Looking Statements
This announcement contains "forward-looking statements" within the
meaning of applicable Canadian securities legislation. Generally,
these forward-looking statements can be identified by the use of
forward-looking terminology such as "plans", "expects" or "does not
expect", "is expected", "budget", "scheduled", "estimates",
"forecasts", "intends", "anticipates" or "does not anticipate", or
"believes" or variations of such words and phrases or state that
certain actions, events or results "may", "could", "would", "might"
or "will be taken", "occur" or "be achieved". Forward-looking
statements are subject to known and unknown risks, uncertainties and
other factors that may cause the actual results, level of activity,
performance or achievements of Cynapsus to be materially different
from those expressed or implied by such forward-looking statements,
including but not limited to those risks and uncertainties relating
to Cynapsus' business disclosed under the heading "Risk Factors" in
its Annual Information Form filed on November 1, 2012 and its other
filings with the various Canadian securities regulators which are
available online at www.sedar.com. Although Cynapsus has attempted to
identify important factors that could cause actual results to differ
materially from those contained in forward-looking statements, there
may be other factors that ca
use results not to be as anticipated,
estimated or intended. There can be no assurance that such statements
will prove to be accurate, as actual results and future events could
differ materially from those anticipated in such statements.
Accordingly, readers should not place undue reliance on
forward-looking statements. Cynapsus does not undertake to update any
forward-looking statements, except in accordance with applicable
This press release does not constitute an offer to sell or a
solicitation to buy any securities in the United States.
The TSXV has neither approved nor disapproved the contents of this
press release. Neither the TSXV nor its Regulation Services Provider
(as that term is defined in the policies of the TSXV) accepts
responsibility for the adequacy or accuracy of this release.
President and CEO
(416) 703-2449 x225
COO & CFO
(416) 703-2449 x253
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