Crescita Signs Exclusive 8-Country Licensing Agreement with Egis Pharmaceuticals for Pliaglis®

Rhea-AI Summary

Crescita Therapeutics Inc. (TSX: CTX, OTC: CRRTF) has entered into an exclusive commercialization and supply agreement with Egis Pharmaceuticals PLC for its product Pliaglis. This agreement covers eight countries in Central Eastern Europe and includes an upfront payment of €0.65 million (CAD $0.94 million), along with potential sales and regulatory milestone payments. Egis plans to launch Pliaglis in Poland in early 2023, further expanding Crescita's product presence, which is now licensed in 40 countries.

Positive

• Crescita secured an exclusive agreement with Egis for Pliaglis in eight countries.
• Upfront payment of €0.65 million (CAD $0.94 million) enhances cash flow.
• Potential for additional sales and regulatory milestone payments.
• Pliaglis is set to launch in Poland in early 2023, increasing market presence.

Negative

• None.

LAVAL, Québec--(BUSINESS WIRE)-- Crescita Therapeutics Inc. (TSX: CTX and OTC US: CRRTF) (“Crescita”), a growth-oriented, innovation-driven Canadian commercial dermatology company, is pleased to announce that it has signed an exclusive commercialization and supply agreement with Egis Pharmaceuticals PLC (“Egis”), a leading generic pharmaceutical company in Central Eastern Europe (the “CEE”) for the rights to Pliaglis in eight countries comprising: Hungary, Bulgaria, Czech Republic, Slovakia, Poland, Russia, Latvia and Lithuania (the “Territories”).

Under the terms of the agreement, Crescita will receive an upfront payment of €0.65M (CAD$0.94M) and is eligible for further cumulative sales and regulatory milestone payments over the term of the agreement. Egis will sell Pliaglis through its own commercial infrastructure in CEE and Russia, where the company is well established. Crescita will be the exclusive supplier of Pliaglis at a defined price per unit and will also provide regulatory support to Egis in seeking approval for Pliaglis in the Territories. Egis expects to launch Pliaglis in Poland in early 2023 and will submit the requisite regulatory filings as soon as practicable to ensure that Pliaglis is launched promptly in the other territories.

“We are extremely pleased to partner with Egis. With its commitment to innovation, strong international presence and robust sales network, Egis represents a partner of choice in these Territories,” said Serge Verreault, President and CEO of Crescita. “Yet again, we have further expanded the footprint of Pliaglis worldwide, where it is now licensed in a total of 40 countries. Pliaglis is a pivotal asset for Crescita and is key to helping unlock the long-term value of our company. We look forward to a strong collaboration with Egis as we continue to secure recurring revenue streams,” added Mr. Verreault.

“We are glad to enter such a great and promising partnership with Crescita. Pliaglis will be a flagship product in our new portfolio providing an excellent therapeutic solution in aesthetic dermatology. With its strong R&D focus in dermatology, we hope to further build this partnership and bring additional value-added medical solutions for patients via Egis’ excellent commercial capabilities in the region,” stated Dr. István Hodász, CEO of Egis.

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. We also 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 Egis Pharmaceuticals PLC

Egis (member of the Servier Group) headquartered in Budapest, Hungary, is one of the leading generic pharmaceutical companies in Central and Eastern Europe. The company’s activities extend to every field of the pharmaceutical value chain: from research and development through the production of active pharmaceutical ingredients and finished drug products to sales and marketing. Egis products are available in 60 countries through its network of subsidiaries and representative offices or partners.

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 the active ingredients 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 information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). 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, strategy for customer retention, product development, market position, business prospects, opportunities and industry trends 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 current beliefs, expectations and assumptions regarding the future of the Company’s 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 the Company’s most recent annual MD&A for the year ended December 31, 2020 and the Company’s AIF dated March 24, 2021. Any forward-looking statement made in this press release is based only on information currently available 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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Crescita Therapeutics

Investor Relations

Linda Kisa, CPA, CA

Email: lkisa@crescitatx.com

Source: Crescita Therapeutics

FAQ

What is the new agreement announced by Crescita Therapeutics for Pliaglis?

Crescita Therapeutics announced an exclusive commercialization and supply agreement with Egis Pharmaceuticals for Pliaglis in eight countries in Central Eastern Europe.

What financial benefits will Crescita receive from the Egis agreement?

Crescita will receive an upfront payment of €0.65 million (CAD $0.94 million) and may earn additional sales and regulatory milestone payments.

When will Pliaglis be launched in Poland?

Egis Pharmaceuticals plans to launch Pliaglis in Poland in early 2023.

How many countries is Pliaglis now licensed in?

Pliaglis is now licensed in a total of 40 countries worldwide.

What is the significance of the partnership with Egis for Crescita?

The partnership with Egis is expected to expand Crescita's market reach and secure recurring revenue streams.