PharmaTher Signs
Exclusive Worldwide
License
Agreement for
Patented
Microneedle
Delivery Technology to Deliver Ketamine
TORONTO,
February 1,
2021--
InvestorsHub NewsWire --
Newscope Capital Corporation (CSE: PHRM)
(OTCQB:
PHRRF),
who
through its wholly-owned subsidiary, PharmaTher
Inc. ("PharmaTher"),
is
a specialty life sciences company focused on the research and
development of psychedelic pharmaceuticals,
is pleased to announce that
PharmaTher
has entered into an Exclusive
Worldwide
Patent and Know-how
License Agreement (the "Agreement") with
The
Queen's University
of
Belfast
("QUB")
for the development and commercialization
of
a patented
hydrogel-forming
microneedle delivery technology developed by
Professor
Ryan Donnelly
to support PharmaTher's
product and clinical development
initiatives
with ketamine.
PharmaTher will
incorporate KETABET™,
its
licensed patented
formulation that
combines FDA-approved ketamine and betaine, with
Professor
Donnelly's patented
hydrogel-forming microneedle ("MN") patch
technology.
The
proposed KETABET™
MN
patch offers
a
potential game-changing therapeutic solution to treat mental health
disorders,
neurological and pain disorders.
Most
recently, Professor
Donnelly's
lab
successfully
completed
research and published a paper titled "Hydrogel-forming microneedle
arrays as a therapeutic option for transdermal esketmaine
delivery" validating
the
delivery
of esketamine,
the
the S(+) enantiomer of
ketamine, in a novel
microneedle patch which may overcome
the drawbacks associated with ketamine administration in
an intravenous
or
nasal spray
format.1
The FDA
granted Fast Track and Breakthrough Therapy designations for
SPRAVATO® (esketamine) nasal spray and in March 2019 approved
SPRAVATO®, in conjunction with an oral antidepressant, for
treatment-resistant depression to Janssen Pharmaceuticals, Inc.
SPRAVATO® requires numerous administration sessions in a certified
medical office under medical supervision by a health care
provider.3
An equity
analyst predicted that SPRAVATO® could generate $3 billion in peak
sales.4
PharmaTher's
KETABET™
MN
patch
aims
to
empower patients to dose their medication remotely, safely and
conveniently rather than being under supervision by a healthcare
provider at a certified medical office.
KETABET™ MN patch has the potential for enabling continuous
delivery of KETABET™
(without pain)
with minimal formulation manipulation
into systemic circulation while
maintaining
constant plasma levels
for
more than
24 hours
that will improve efficacy and compliance for
patients.1-2
Also,
PharmaTher's
KETABET™
MN patch will
incorporate anti-tampering and anti-abuse features
because
of the combined presence of ketamine and betaine and the delivery
format of the product that would parallel the approach used for the
tamper-resistant transdermal fentanyl patch.
PharmaTher
has the exclusive
worldwide
license for
KETABET™
which
has shown in clinical research to enhance the antidepressant effect
while having the potential to significantly reduce the known
negative side effects of ketamine.5
Side effects such as hallucinations, confusion, memory loss and
abuse liability compromise the compliance and potential therapeutic
value of ketamine.
The patented
MN technology
licensed
by PharmaTher consists of
hydrogel-forming microneedle arrays and accompanying reservoir
which will overcome any limitations by the quantity of drug that
can be loaded into the needles or onto the needle surfaces. As
such, the
MN
technology can
greatly
increase the amount of drug
that can permeate through the microneedle
array and
into the skin.2
"With
this
exclusive
license
we have created a solid
intellectual
property
foundation
and a
development and
commercialization
path
for
KETABET™
MN
patch
that could
potentially
change the way
how
mental
health,
neurological and pain disorders
are
treated,"
said Fabio Chianelli, CEO
of PharmaTher. "We are pursuing
the clinical
development of
KETABET™
MN
patch
to
overcome the current
limitations of
ketamine
and to unlock the known potential therapeutic
value
of
ketamine
as a
prescription for regulatory approval
worldwide.
We look forward to working with Professor
Donnelly
in delivering
the
next
generation ketamine
solution."
Professor
Ryan
Donnelly commented:
"Our
recent research
with
esketamine in our patented microneedle technology
shows the
potential of an alternative
delivery
method that can
overcome
the limitations of current ketamine delivery options
without
comprising
the
safety and compliance of patients.
I am
excited to work with PharmaTher in their quest to develop
a next
generation ketamine solution that could help the millions of people
who suffer from mental health worldwide."
Professor
Ryan
Donnelly is the Chair of Pharmaceutical Technology at
QUB.
He is a leading expert and researcher in the field of transdermal
delivery with primary focus on microneedle drug delivery and its
applications on improving therapeutic outcomes for
patients.
He has authored over 600 peer-reviewed publications,
including several
granted patents, 5
textbooks and approximately
250
full papers. His
work has attracted numerous awards, including the
Academy of Pharmaceutical Sciences Innovative Science Award in
2020, the
Controlled Release Society Young Investigator Award in 2016, BBSRC
Innovator of the Year in 2013, the GSK Emerging Scientist Award in
2012 and the Royal Pharmaceutical Society Science Award in
2011. He graduated with a
B.Sc. degree in pharmacy (1999) and a Ph.D. in pharmaceutics (2003)
from QUB.
Under the
terms of the Agreement, PharmaTher
gained
exclusive worldwide development and
commercial rights to
an
intellectual
property portfolio consisting
of granted
patents in
the U.S.,
Europe, Japan, India and China and know-how
pursuant
to the hydrogel-forming microneedle technology for
use
in the
field of ketamine,
esketamine,
betaine
and
combinations
thereof.
PharmaTher and QUB
agreed to terms consistent with industry standards, including
future payments based on clinical trial and revenue
milestones.
About
PharmaTher Inc.
PharmaTher Inc., a
wholly-owned subsidiary of Newscope Capital Corporation (CSE:
PHRM)
(OTCQB:
PHRRF), is a specialty life
sciences company focused on the research and development of
psychedelic pharmaceuticals, such as ketamine and
psilocybin, for FDA approval to
treat mental health,
neurological
and
pain disorders.
Learn
more at: PharmaTher.com and
follow us on
Twitter, LinkedIn
and Facebook.
For more
information, please contact:
Fabio
Chianelli
Chief
Executive Officer
PharmaTher
Inc.
Tel:
1-888-846-3171
Email:
info@pharmather.com
Website:
www.pharmather.com
Neither
the Canadian Securities Exchange nor its Regulation Services
Provider have reviewed or accept responsibility for the adequacy or
accuracy of this release.
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Statement
This
press release contains 'forward-looking information' within the
meaning of applicable Canadian securities legislation. These
statements relate to future events or future performance. The use
of any of the words "could", "intend", "expect", "believe", "will",
"projected", "estimated", "potential",
"aim" and
similar expressions and statements relating to matters that are not
historical facts are intended to identify forward-looking
information and are based on the Newscope
Capital Corporation's (the "Company) current
belief or assumptions as to the outcome and timing of such future
events. Forward-looking
information is based on reasonable assumptions that have been made
by the Company at the date of the information and is subject to
known and unknown risks, uncertainties, and other factors that may
cause actual results or events to differ materially from those
anticipated in the forward-looking information. Given these risks,
uncertainties and assumptions, you should not unduly rely on these
forward-looking statements. The forward-looking information
contained in this press release is made as of the date hereof, and
Company is not obligated to update or revise any forward-looking
information, whether as a result of new information, future events
or otherwise, except as required by applicable securities laws. The
foregoing statements expressly qualify any forward-looking
information contained herein. Factors that could cause actual
results to differ materially from those anticipated in these
forward-looking statements are described under the caption "Risk
Factors" in Company's management's discussion and analysis for the
period of November
30,
2020 ("MD&A"), dated January
27,
2021,
which is available on the Company's profile at www.sedar.com.
This
news release does not constitute an offer to sell or the
solicitation of an offer to buy, and shall not constitute an offer,
solicitation or sale in any
state, province, territory or jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such state,
province, territory or jurisdiction.
References:
-
Courtenay, et al. Hydrogel-forming microneedle arrays as a
therapeutic option for transdermal esketamine delivery,
Journal of Controlled Release, Volume 322, 2020, Pages
177-186.
-
Donnelly R.F. Hydrogel-forming microneedles prepared from "super
swelling" polymers combined with lyophilised
wafers for transdermal drug delivery. PLoSONE. 2014
doi: 10.1371/journal.pone.0111547.
-
https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
-
https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
-
J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine
enhances antidepressant-like, but blocks psychotomimetic effects of
ketamine in mice, Psychopharmacology (Berl). 233 (2016)
3223–32
