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2014-05-14

Cynapsus Therapeutics Inc. : Cynapsus Announces No Buccal Mucosal Irritation in FDA Registration Study of APL-130277 for Parkinson's Disease

TORONTO, CANADA - Cynapsus Therapeutics Inc. (CTH: TSX-V) (CYNAF: OTCQX), a
specialty pharmaceutical company, today announced no irritation was observed
when testing the APL-130277 sublingual apomorphine formulation in a buccal
mucosal irritation model in hamsters, either macroscopically (clinician
observation of oral cavity) or microscopically. The study was conducted in
compliance with the Good Laboratory Practice for Nonclinical Laboratory
Studies of the United States Food and Drug Administration ("FDA"), 21 CFR
Part 58, and OECD Principles of Good Laboratory Practice (OECD, 1998).

APL-130277 is an easy-to-administer, fast-acting and proprietary reformulation
of apomorphine for sublingual delivery. Injectable apomorphine is the only
approved drug in the United States, Europe, Japan and other countries for the
acute rescue of "off" motor symptoms of Parkinson's disease. The APL-130277
thin film strip system technology is specifically designed to provide
enhanced convenience and eliminate buccal mucosal irritation, among other
attributes.

Mr. Anthony Giovinazzo, President and CEO of Cynapsus commented: "The data,
coupled with our clinical results to date, continues to validate the design
of our thin-film strip technology. Since we started the development of
APL-130277, we have been aware of the possibility of buccal mucosa irritation
with extended use, so we determined it was prudent to complete this
irritation study sooner rather than later. This study is also a required
registration study by the FDA. We are encouraged with the results, and look
forward to demonstrating similar results in upcoming human clinical trials
planned over the next 24 months. This study provides evidence that APL-130277
may provide therapeutic levels of apomorphine dosing with low or no
irritation when used by Parkinson's patients multiple times per day on a
daily basis."

The APL-130277 strips have also been administered in approximately 100 healthy
human volunteers in single dose studies, with no evidence of irritation.

About The
Buccal Mucosal Irritation Model

In the study, three times each day for 28 consecutive days, an equal number of
placebo and apomorphine containing thin strips were placed in the cheek of
the animals. The dose used in the study was significantly higher, on a
relative weight adjusted basis, than what would normally be given to
patients. Care was taken to apply the thin strips to the same region of each
cheek pouch for every dose application.

There was no external evidence of irritation based on clinical evaluations of
the cheek pouches during the study and at the end of the 28 days of dosing.

In microscopic analysis there was no observed evidence of irritation or
inflammation.

About Apomorphine

Apomorphine, a potent dopamine agonist, is the only drug approved specifically
for the treatment of acute motor fluctuations/hypomobility (freezing or "off"
episodes) in patients with advanced Parkinson's disease. Presently,
apomorphine is administered by intermittent subcutaneous injection usually
via a pre-filled injection pen, or, in some cases outside the United States,
by continuous infusion pump. Drawbacks associated with subcutaneous injection
therapy for patients and caregivers include aversion to needles, the need for
multiple injections, which can be painful and are often associated with
irritation and inflammation at the injection site, and the requirement for a
degree of manual dexterity that some Parkinson's patients find difficult.

About Cynapsus Therapeutics

Cynapsus is a specialty pharmaceutical company developing a convenient and
easy to use sublingual (oral) thin film strip for the acute rescue of "off"
motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277,
is an easy-to-administer, fast-acting reformulation of apomorphine, which is
the only approved drug (in the United States, Europe, Japan and other
countries) 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 ("NDA") expected to be submitted in 2016.

Over one million people in the U.S. and an estimated 4 to 6 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 Corporation'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 disease progresses.

More information about Cynapsus (TSX-V: CTH) (OTCQX: CYNAF) is available
atwww.cynapsus.caand at the System for Electronic Document Analysis and
Retrieval (SEDAR) atwww.sedar.com.

Contact Information

Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
ajg@cynapsus.ca

Andrew Williams
COO&CFO
(416) 703-2449 x253
awilliams@cynapsus.ca

Forward Looking Statements

This announcement contains "forward-looking statements" within the meaning of
applicable securities laws. 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 March 26, 2014, Annual Information Form and its other
filings with the various Canadian securities regulators which are available
online atwww.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
cause 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 securities
laws.

Neither the TSX Venture Exchange nor the OTCQX International has approved or
disapproved the contents of this press release.

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Cynapsus Therapeutics Inc. via Globenewswire

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