Crescita Therapeutics Inc. (TSX: CTX) (OTC US: CRRTF)
(“Crescita”), a growth-oriented, innovation-driven Canadian
commercial dermatology company, and STADA MENA DWC-LLC (“STADA”), a
subsidiary of STADA Arzneimittel AG, a specialty pharma, generics
and consumer healthcare group, today announced an exclusive
commercialization and development license agreement (the
“Agreement”) for the exclusive rights to the topical anaesthetic
cream Pliaglis®, in 15 countries in the Middle East and North
Africa (“MENA”) region, comprising: Saudi Arabia, the United Arab
Emirates (“UAE”), Kuwait, Oman, Qatar, Bahrain, Jordan, Lebanon,
Egypt, Algeria, Morocco, Tunisia, Iraq, Libya and Yemen (the
“Territories”).
Under the terms of the Agreement, STADA will be responsible for
commercializing Pliaglis in the Territories utilizing its
experienced sales force. Crescita will be eligible to receive an
upfront payment and will be the exclusive supplier of Pliaglis at a
defined price per unit. Crescita will also provide regulatory
support to STADA for seeking approval for Pliaglis in the
Territories. STADA expects to submit the requisite regulatory
filings in the Territories as soon as practicable.
“With this agreement, I am proud to say that we have now been
successful in licensing Pliaglis in 32 countries worldwide, a
strategic goal toward which we have been working for the greater
part of the last two years,” commented Serge Verreault, President
and CEO of Crescita. “Selecting the right commercial partners for
Pliaglis is key, and we could not have done better than STADA, a
global pharma player with presence in over 120 countries, as well
as the required network, resources and expertise to make Pliaglis a
success in the MENA region. Pliaglis is currently sold in five
countries, and we believe that as launches and sales ramp-up, we
could see a meaningful impact on Crescita’s recurring revenue from
2024 onwards,” added Mr. Verreault.
“As a proprietary combination of 7% lidocaine and 7% tetracaine,
Pliaglis will fit ideally with STADA MENA’s existing pain portfolio
as well as with its growing pipeline of value-added products,”
commented Carsten Cron, STADA’s Head of Emerging Markets. “We look
forward to working closely with our expert partner, Crescita, to
bring this therapeutic option to patients and healthcare
professionals across the MENA region.”
About Crescita Therapeutics Inc.
Crescita (TSX: CTX and OTC US: CRRTF) is a growth-oriented,
innovation-driven Canadian commercial dermatology company with
in-house R&D and manufacturing capabilities. The Company offers
a portfolio of high-quality, science-based non-prescription
skincare products and early to commercial stage prescription
products. In addition, we own multiple proprietary transdermal
delivery platforms that support the development of patented
formulations that facilitate the delivery of active ingredients
into or through the skin.
About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany.
The company focuses on a three-pillar strategy consisting of
generics, specialty pharma and non-prescription consumer healthcare
products. Worldwide, STADA Arzneimittel AG sells its products in
approximately 120 countries. In financial year 2020, STADA achieved
group sales of EUR 3,010.3 million and adjusted earnings before
interest, taxes, depreciation and amortization (EBITDA) of EUR
713.3 million. As of December 31, 2020, STADA employed 12,301
people worldwide.
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
Crescita'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 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. Pliaglis is currently approved in over
25 different countries and sold by commercial partners in various
countries.
Forward-looking Statements
This press release contains “forward-looking statements” within
the meaning of applicable securities laws. Forward-looking
statements can be identified by words such as: “anticipate”,
“intend”, “plan”, “goal”, “seek”, “believe”, “project”, “estimate”,
“expect”, “strategy”, “future”, “likely”, “may”, “should”, “will”
and similar references to future periods. Examples of
forward-looking statements include, but are not limited to,
statements regarding the Company’s objectives, plans, goals,
strategies, growth, performance, operating results, financial
condition, our belief that we have sufficient liquidity to fund our
business operations during the upcoming fiscal year, strategy for
customer retention, growth, product development, market position,
financial results and reserves, strategy for risk management,
business prospects, opportunities and industry trends, the expected
impact of, and responses taken by the Company with respect to, the
COVID-19 pandemic, and similar statements concerning anticipated
future events, results, circumstances, performance or expectations.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of the Company’s control. Crescita’s actual
results and financial condition may differ materially from those
indicated in the forward-looking statements. Therefore, you should
not unduly rely on any of these forward-looking statements.
Important 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: economic and
market conditions, the impact of the COVID-19 pandemic and the
response thereto of governments and consumers, the Company’s
ability to execute its growth strategies, reliance on third parties
for clinical trials, marketing, distribution and commercialization,
the impact of changing conditions in the regulatory environment and
product development processes, manufacturing and supply risks,
increasing competition in the industries in which the Company
operates, the Company’s ability to meet its debt commitments, the
impact of unexpected product liability matters, the impact of
litigation involving the Company and/or its products, the impact of
changes in relationships with customers and suppliers, the degree
of intellectual property protection of the Company’s products, the
degree of market acceptance of the Company’s products, developments
and changes in applicable laws and regulations, as well as other
risk factors discussed in the “Risk Factors” sections of our annual
management’s discussion and analysis for the year ended December
31, 2020 and the Company’s annual information form dated March 24,
2021. Any forward-looking statement made by the Company in this
press release is based only on information currently available to
management and speaks only as of the date on which it is made.
Except as required by applicable securities laws, Crescita
undertakes no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20210818005409/en/
Crescita Therapeutics Investor Relations Linda Kisa, CPA,
CA Email: lkisa@crescitatx.com
STADA Information for Journalists: STADA Arzneimittel AG
- Media Relations Stadastrasse 2-18 61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165 Fax: +49 (0) 6101 603-215 E-Mail:
press@stada.de Or visit us on the Internet at
www.stada.com/press
STADA Information for Capital Market Participants: STADA
Arzneimittel AG - Investor & Creditor Relations Stadastrasse
2-18 61118 Bad Vilbel – Germany Phone: +49 (0) 6101 603-4689 Fax:
+49 (0) 6101 603-215 E-mail: ir@stada.de
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