Crescita Announces Licensing Agreement for Pliaglis® in China
LAVAL, QC, Nov. 5, 2020 /CNW Telbec/ - 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 exclusive agreement with Juyou-Biotechnology Co. Ltd ("Juyou"), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis® in mainland China (the "License Agreement").
Juyou will be responsible for the overall clinical development and regulatory filings for Pliaglis with the National Medical Products Administration (the "NMPA", formerly the China State Food and Drug Administration). As part of the License Agreement, Crescita will receive an upfront payment in cash of US$125,000 and will be eligible for regulatory and sales milestones of up to US$1.0 million and US$1.8 million. Crescita will supply Pliaglis at a pre-determined price per unit including a profit margin and will also be eligible for double-digit royalties once the product is available for commercial sale.
"We are excited about this new license agreement for Pliaglis in China, the third partnering agreement secured over the last three months, in addition to Austria and Mexico. We see this both as an opportunity to strengthen our geographic presence but to also add a healthy recurring revenue stream in the long-term," said Serge Verreault, President and CEO of Crescita. "While the clinical requirements still need to be validated with NMPA, we estimate that the product could be launched as early as 2023 if no additional studies are required," emphasized Mr. Verreault.
About Juyou Bio-Technology Co. Ltd.
Juyou Bio-Technology Co., Ltd. is an innovative leading enterprise specializing in the research and development, production and sales of biomedical materials, functional skincare products and medical and aesthetic drugs. The scope of the business covers medical beauty services, functional skincare, homecare, and raw materials. With years of extensive experience in the field of skin health, the Company has successively built the "Juyou" brand for skin barrier repair, now recommended by thousands of public hospitals in China; the professional baby skincare brand "Juyou Baby", as well as the "Dermacid" brand, just to name a few. The Company's main sales channels include: public hospitals, medical beauty institutions, dermatology clinics and online e-commerce channels (TMALL flagship store and JD flagship store), international e-commerce channels (Alibaba.com, AliExpress) and its own e-commerce platform.
Relying on independent research and development, the Company has formed gene recombination and fermentation engineering technology, and developed a number of core technologies, such as recombinant collagen, enzymatic and genetic engineering synthesis of bioactive peptides. At present, Juyou has 26 patents, and has established the Juyou research and development center for skin barrier repair with local dermatologists and professional institutions. It is the first such project in China to develop recombinant mussel adhesive protein by gene recombination, fermentation engineering technology and specific enzyme catalytic fusion technology, and is expected to become a leader in this field. For additional information, please visit http://zhanyan.com.cn/en.html.
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.
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. Pliaglis is currently approved in over 25 different countries and sold by commercial partners in the U.S., Italy, and Brazil, sold in Canada by the Company, and was most recently licensed to partners in Austria and Mexico.
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.
SOURCE Crescita Therapeutics Inc.
Investor Relations, Email: [email protected]
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