Crescita Therapeutics and STADA Enter 15-Country Exclusive Licensing Agreement for Pliaglis®

Rhea-AI Summary

Crescita Therapeutics Inc. (OTC US: CRRTF) has entered into an exclusive commercialization agreement with STADA MENA for its topical anesthetic cream, Pliaglis^®, in 15 countries across the Middle East and North Africa (MENA). This partnership allows STADA to commercialize Pliaglis while Crescita will supply the product and provide regulatory support. The agreement marks Crescita's success in licensing Pliaglis in 32 countries, with expectations of increased recurring revenue starting in 2024. Pliaglis, a lidocaine and tetracaine combination, offers effective local analgesia for dermatological procedures.

Positive

• Exclusive agreement with STADA MENA for Pliaglis in 15 MENA countries.
• Crescita has successfully licensed Pliaglis in 32 countries worldwide.
• Potential for increased recurring revenue starting in 2024.

Negative

• None.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210818005409/en/

FAQ

What is the significance of the agreement between Crescita Therapeutics and STADA MENA for CRRTF stock investors?

The exclusive commercialization agreement allows Crescita to expand Pliaglis's market presence, potentially boosting revenue and positively impacting CRRTF stock.

Which countries are included in the Crescita and STADA agreement for Pliaglis?

The agreement covers 15 countries in the MENA region including Saudi Arabia, UAE, Kuwait, Qatar, and others.

When can we expect to see revenue from the Pliaglis agreement impact Crescita's performance?

Crescita anticipates a meaningful impact on recurring revenue from Pliaglis starting in 2024.

What is Pliaglis and its intended use?

Pliaglis is a topical anesthetic cream that provides local analgesia for dermatological procedures and combines lidocaine and tetracaine.

How does this agreement affect Crescita's business strategy?

The agreement enhances Crescita's strategy to establish a broader market for its products while leveraging STADA's resources.