LAVAL, QC, July 28, 2020 /PRNewswire/ - Crescita
Therapeutics Inc. (TSX: CTX) (OTC US: CRRTF) ("Crescita" or
the "Company"), a growth-oriented, innovation-driven Canadian
commercial dermatology company with in-house research &
development ("R&D") and manufacturing capabilities, today
announced that it has entered into an amendment to the development
and commercialization agreement (the "Amendment") with Taro
Pharmaceuticals Inc. ("Taro") with regard to
Pliaglis® in the United
States ("U.S.").
The Amendment entitles Crescita to receive a one-time payment of
US$3.9 million (approximately
CAD$5.2 million), largely
representing a royalty adjustment to past sales as well as an
upward modification of future royalty payments.
The Company continues to pursue out-licensing partnerships with
focus on approximately 20 countries where Pliaglis has already
received regulatory approval.
About Crescita
Therapeutics Inc.
Crescita is a growth-oriented,
innovation-driven Canadian commercial dermatology company with
in-house R&D and manufacturing capabilities. The Company offers
a portfolio of non-prescription skincare products and early to
commercial stage prescription drug products and owns multiple
proprietary drug delivery platforms that support the development of
patented formulations that can facilitate the delivery of active
ingredients into or through the skin.
Supported by a sales force covering Canada and executing a business to business to
consumer marketing approach, Crescita sells its non-prescription
skincare products domestically through spas, medispas, and medical
clinics, as well as internationally, through distributors.
Crescita's portfolio also includes a prescription product called
Pliaglis®, that utilizes the Company's proprietary
phase-changing topical cream Peel technology, a part of the
DuraPeel™ family, which are
self-occluding, film-forming cream/gel formulations, that provide
extended release delivery of the active ingredients to the site of
application. 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, and sold in Canada by the Company.
Crescita's expertise in product formulation and development can
be leveraged in combination with its patented transdermal delivery
technologies to develop and manufacture creams, liquids, gels,
ointments and serums under its contract development and
manufacturing organization ("CDMO") infrastructure. The Company
operates out of a 50,000 square-foot facility located in
Laval, Québec, which produces the
majority of its non-prescription skincare products, such as
Laboratoire Dr Renaud, Pro-Derm, Dermazulene and Alyria.
Formulations manufactured by or for Crescita include cosmetics,
natural health products ("NHP") and products with Drug
Identification Numbers ("DIN"). For additional information, please
visit www.crescitatherapeutics.com.
About Pliaglis®
Pliaglis is a
topical local anaesthetic cream that provides safe and effective
local dermal analgesia on intact skin prior to superficial
dermatological procedures. The formulation contains a
eutectic mixture of 7% lidocaine and 7% tetracaine that utilizes
the Company's 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. Pliaglis is applied
to intact skin for 20 to 30 minutes prior to superficial
dermatological procedures such as dermal filler injections,
non-ablative laser facial resurfacing, or pulsed-dye laser therapy
and 60 minutes prior to procedures such as laser-assisted tattoo
removal. Following the application period, the pliable layer is
easily removed from the skin allowing the procedure to be performed
with minimal to no pain. In clinical studies, the mean duration of
anesthesia has been shown to be in the range of 7 to 9 hours after
the application of Pliaglis.
About Taro Pharmaceuticals Industries Inc.
Taro
Pharmaceutical Industries Ltd. is a multinational, science-based
pharmaceutical company, dedicated to meeting the needs of its
customers through the discovery, development, manufacturing and
marketing of the highest quality healthcare products. For
further information on Taro Pharmaceutical Industries Ltd., please
visit the Company's website at www.taro.com.
Forward-Looking Statements
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" "continue" or "temporary"
and similar expressions identify forward-looking statements
and include statements regarding the Company's plans, objectives
and responses to the COVID-19 pandemic. 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 the risks of, and future impacts related to, COVID-19,
including the response of domestic and international governments to
the virus; the impact of COVID-19 on the Company's operations,
personnel, supply chain, product sales, royalties, customer demand
and financial flexibility; 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
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 authorities and commissions. These
and other factors should be considered carefully, and readers
should not place undue reliance on Crescita's forward-looking
statements when making decisions, 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.
All forward-looking statements are based only on information
currently available to the Company and are made as of the date of
this press release. Except as expressly required by applicable
Canadian securities law, the Company assumes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events or otherwise. All
forward-looking statements in this press release are qualified by
these cautionary statements.
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SOURCE Crescita Therapeutics Inc.
