LAVAL, QC, Nov. 5, 2019 /PRNewswire/ - Crescita
Therapeutics Inc. (TSX: CTX) (OTC US: CRRTF) ("Crescita"), a
commercial dermatology company with manufacturing capabilities and
a portfolio of non-prescription skincare products and prescription
drug products for the treatment and care of skin conditions,
diseases and their symptoms, today announced that the U.S.
Food and Drug Administration ("FDA") approved the enhanced
formulation of Pliaglis® (the "Enhanced Formulation")
following its statutory six-month review process and in line with
the target action date under the Prescription Drug User Fee Act
("PDUFA"). While the U.S. patent covering the original
formulation of Pliaglis® expired on September 28. 2019, the U.S. patent covering the
Enhanced Formulation with extended protection to 2031, is in the
process of being added to the Orange Book.
On May 2, 2019, our licensing
partner for the U.S. market, Taro Pharmaceuticals Inc. ("Taro")
filed a CBE-30 supplement seeking approval for an enhanced
formulation of Pliaglis which has improved application and removal
properties as well as extended patent protection until 2031 in the
U.S. and several other jurisdictions. The approval of the Enhanced
Formulation triggers a US$0.75
million milestone under the terms of the out-licensing
agreement in place with Taro.
"We are delighted with the FDA's approval of the Enhanced
Formulation of Pliaglis," said Serge
Verreault, President and CEO of Crescita. "With an improved
formulation and extended patent protection, we are very optimistic
about extending the commercial life of Pliaglis for many years to
come."
About Pliaglis®
Pliaglis, a lidocaine and
tetracaine (7%/7%) formulation, is a prescription topical local
anesthetic cream approved in over 25 countries that provides safe
and effective local dermal anesthesia on intact skin prior to
superficial dermatological procedures, such as dermal filler
injections, pulsed dye laser therapy, facial laser resurfacing and
laser-assisted tattoo removal. This product utilizes the
proprietary phase-changing topical cream Peel technology. The Peel
technology consists of a drug containing cream which, once applied
to a patient's skin, dries to form a pliable layer that releases
drug into the skin. Following the application period, Pliaglis
forms a pliable layer that is removed from the skin allowing the
dermatological procedure to be performed with minimal to no
pain.
About the Enhanced Formulation
The Company developed
an enhanced formulation of Pliaglis, that also contains 7%
lidocaine and 7% tetracaine but possesses improved application and
removal properties compared to Pliaglis, with extended patent
protection to 2031 in multiple jurisdictions. Like Pliaglis, the
formulation dries to form a pliable layer which can be easily
peeled from the skin once the active ingredients have been
delivered to the site on the body, providing a long-lasting
anesthetic effect. The Company also developed alternate
enhanced versions of Pliaglis and filed additional patent
applications that may provide supplemental protection for the
enhanced formulations of Pliaglis. On July
16, 2019, the United States Patent and Trademark Office
granted U.S. Patent No. 10,350,180 for the FDA-approved enhanced
formulation of Pliaglis
About Crescita Therapeutics Inc.
Crescita (TSX: CTX
and OTC US: CRRTF) is a publicly traded, Canadian commercial
dermatology company with manufacturing capabilities and a portfolio
of non-prescription skincare products for the treatment and care of
skin conditions, diseases and their symptoms and prescription drug
products for the treatment of pain. Crescita owns multiple
proprietary drug delivery platforms that support the development of
patented formulations that can facilitate the delivery of active
drugs into or through the skin.
Supported by a sales force covering Canada and executing its business to business
to consumer marketing approach, Crescita sells its non-prescription
products through spas, medispas and medical clinics.
In addition, our brands and formulations are currently sold
in the U.S. and certain Asian markets through international
distributors as well as through a leading cross-border e-commerce
channel in China.
Crescita developed a prescription product called
Pliaglis® that utilizes our proprietary
phase-changing topical cream Peel technology. Pliaglis is a topical
local anaesthetic cream that provides safe and effective local
dermal analgesia on intact skin prior to superficial dermatological
procedures. The product is currently approved in over 25 different
countries and sold by commercial partners in the U.S., Italy and Brazil.
Crescita also provides contract development and manufacturing
services to several local and North American clients. Our contract
development and manufacturing organization infrastructure allows
Crescita to provide its clients with development and other support
activities required to bring their products to market. Crescita has
extensive expertise in product formulation and development,
leveraging our patented transdermal delivery technologies, and
specializes in manufacturing creams, liquids, gels ointments and
serums. The Company operates out of a 50,000 square-foot
manufacturing facility located in Laval, Québec that is compliant with current
Canadian Good Manufacturing Practices and is regularly inspected by
Health Canada.
Forward-Looking Information Cautionary Statement
This
press release contains "forward-looking information" as defined
under Canadian securities laws (collectively, "forward-looking
statements"). The words "plans", "expects", "does not expect",
"goals", "seek", "strategy", "future", "estimates", "intends",
"anticipates", "does not anticipate", "projected", "believes" or
variations of such words and phrases or statements to the effect
that certain actions, events or results "may", "will", "could",
"would", "should", "might", "likely", "occur", "be achieved" or
"continue" and similar expressions identify forward-looking
statements. In addition, any statements that refer to expectations,
intentions, projections or other characterizations of future events
or circumstances contain forward-looking statements.
Forward-looking statements are not historical facts but instead
represent management's expectations, estimates, projections and
assumptions regarding future events or circumstances. Such
forward-looking statements are qualified in their entirety by the
inherent risks, uncertainties and changes in circumstances
surrounding future expectations which are difficult to predict and
many of which are beyond the control of the Company.
Forward-looking statements are necessarily based on a number of
estimates and assumptions that, while considered reasonable by
management of the Company as of the date of this press release, are
inherently subject to significant business, economic
and competitive uncertainties and contingencies. Material
factors and assumptions used to develop the forward-looking
statements, and material risk factors that could cause actual
results to differ materially from the forward-looking statements,
include but are not limited to changes in the business
or affairs of Crescita; the ability of Crescita's licensees to
successfully market its products; competitive factors in the
industries in which Crescita operates; relationships with
customers, suppliers and licensees; changes in legal and regulatory
requirements; foreign exchange and interest rates; prevailing
economic conditions; and other factors, many of which are beyond
the control of Crescita.
Additional factors that could cause Crescita's actual results
and financial condition to differ materially from those indicated
in the forward-looking statements include, among others, the risk
factors included in Crescita's most recent Annual Information Form
dated March 18, 2019 under the heading "Risks Factors",
and as described from time to time in the reports and disclosure
documents filed by Crescita with Canadian securities regulatory
agencies and commissions. These and other factors should be
considered carefully, and readers should not place undue reliance
on Crescita's forward-looking statements, as forward-looking
statements involve significant risks and uncertainties.
Forward-looking statements should not be read as guarantees of
future performance or results and will not necessarily be accurate
indications of whether or not the times at or by which such
performance or results will be achieved.
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SOURCE Crescita Therapeutics Inc.