U.S. Food and Drug Administration Approves Enhanced Formulation of Pliaglis®
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.
