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Endo Announces Agreement for Paladin Pharma to Commercialize Wynzora® Cream in Canada

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Endo has signed a definitive agreement with MC2 Therapeutics to commercialize Wynzora® Cream (calcipotriene and betamethasone dipropionate) in Canada through its subsidiary Paladin Pharma. The cream, designed to treat plaque psoriasis, is pending Health Canada approval. The product has already received FDA approval in July 2020 and was launched in Europe in February 2022. This agreement aims to expand the availability of Wynzora® Cream's unique formulation to Canadian patients, offering a new treatment option designed for convenient daily use.

Endo ha firmato un accordo definitivo con MC2 Therapeutics per commercializzare Wynzora® Cream (calcipotriene e betametasone dipropionato) in Canada tramite la sua filiale Paladin Pharma. La crema, progettata per trattare la psoriasi a placche, è in attesa di approvazione da parte di Health Canada. Il prodotto ha già ricevuto l'approvazione della FDA nel luglio 2020 ed è stato lanciato in Europa nel febbraio 2022. Questo accordo mira ad ampliare la disponibilità della formulazione unica di Wynzora® Cream per i pazienti canadesi, offrendo un'opzione terapeutica nuova progettata per un uso quotidiano conveniente.

Endo ha firmado un acuerdo definitivo con MC2 Therapeutics para comercializar Wynzora® Cream (calcipotrieno y dipropionato de betametasona) en Canadá a través de su subsidiaria Paladin Pharma. La crema, diseñada para tratar la psoriasis en placas, está pendiente de aprobación por parte de Health Canada. El producto ya recibió la aprobación de la FDA en julio de 2020 y se lanzó en Europa en febrero de 2022. Este acuerdo tiene como objetivo expandir la disponibilidad de la formulación única de Wynzora® Cream para los pacientes canadienses, ofreciendo una nueva opción de tratamiento diseñada para un uso diario conveniente.

EndoMC2 Therapeutics와 캐나다에서 Wynzora® Cream (칼시포트리엔 및 베타메타손 디프롭ionato)를 상용화하기 위한 최종 계약을 체결했습니다. 이 크림은 플라크 건선을 치료하기 위해 설계되었으며, 현재 Health Canada의 승인을 기다리고 있습니다. 이 제품은 2020년 7월 FDA 승인을 받았으며, 2022년 2월 유럽에서 출시되었습니다. 이번 계약은 Wynzora® Cream의 독창적인 제형을 캐나다 환자들에게 제공하여 편리한 일상적 사용을 위한 새로운 치료 옵션을 제공하는 것을 목표로 하고 있습니다.

Endo a signé un accord définitif avec MC2 Therapeutics pour commercialiser la Wynzora® Cream (calcipotriène et dipropionate de bétaméthasone) au Canada par l'intermédiaire de sa filiale Paladin Pharma. Cette crème, conçue pour traiter le psoriasis en plaques, attend l'approbation de Santé Canada. Le produit a déjà reçu l'approbation de la FDA en juillet 2020 et a été lancé en Europe en février 2022. Cet accord vise à élargir la disponibilité de la formulation unique de la Wynzora® Cream pour les patients canadiens, offrant une nouvelle option de traitement conçue pour un usage quotidien pratique.

Endo hat einen endgültigen Vertrag mit MC2 Therapeutics unterzeichnet, um Wynzora® Cream (Calcipotriol und Betamethason-Dipropionat) über seine Tochtergesellschaft Paladin Pharma in Kanada zu vertreiben. Die Creme, die zur Behandlung von Plaque-Psoriasis entwickelt wurde, wartet auf die Genehmigung durch Health Canada. Das Produkt erhielt bereits im Juli 2020 die FDA-Zulassung und wurde im Februar 2022 in Europa eingeführt. Dieses Abkommen zielt darauf ab, die Verfügbarkeit der einzigartigen Formulierung von Wynzora® Cream für kanadische Patienten zu erweitern und eine neue Behandlungsoption für den täglichen Gebrauch anzubieten.

Positive
  • Expansion into Canadian market through commercialization agreement
  • Product already approved in US and European markets
Negative
  • None.

MALVERN, Pa., Nov. 15, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that it has entered into a definitive agreement with MC2 Therapeutics ("MC2") to commercialize Wynzora® Cream (calcipotriene and betamethasone dipropionate) in Canada through Endo's subsidiary Paladin Pharma Inc.

"We look forward to working with MC2 to make Wynzora® Cream available to Canadians who suffer from plaque psoriasis," said Livio Di Francesco, Vice President and General Manager of Paladin. "If approved by Health Canada, Wynzora® Cream's unique formulation and clinical profile will offer patients a new treatment option designed for convenience of use in daily routines."

"Paladin has an experienced and dedicated team, and we're pleased to work with them to introduce Wynzora® Cream in Canada," said Jesper J. Lange, Chief Executive Officer, MC2 Therapeutics. "The agreement aligns with our strategy to make Wynzora® Cream available to as many patients suffering from plaque psoriasis as possible globally."

Wynzora® Cream was approved in the US by the FDA on July 20, 2020 and launched in Europe on February 18, 2022. 

About Wynzora® Cream
Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis, including scalp psoriasis, in adults. Its dual mode of action is targeting the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF-α expression in a single product. Wynzora® Cream is uniquely enabled by MC2's formulation and drug delivery system PAD Technology, allowing a convenient-to-use aqueous formulation.

About Endo and Paladin Pharma
Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.

Paladin Pharma Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market.  Paladin has a focused marketing, medical and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies.  Paladin is an operating company of Endo, Inc. For more information, visit www.paladin-pharma.com.

About MC2 Therapeutics (www.mc2therapeutics.com)
MC2 Therapeutics is a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation. Its pioneering approach in immunology is anchored in a deep understanding of skin biology, clinical expertise and cross-silo thinking. Besides Wynzora® Cream, MC2 has a pipeline that includes two first-in-class drug candidates, both in Phase 2 clinical development.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Messrs. Di Francesco and Lange and any statements relating to product development and commercialization, treatment options and therapies, regulatory approval, efficacy and product availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable or delayed regulatory review, uncertainties in and the timing for regulatory approval, changes in competitive, market or regulatory conditions, and consumer and physician acceptance of current and new products. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A.

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SOURCE Endo, Inc.

FAQ

What is the new commercialization agreement for Endo (NDOI) in Canada?

Endo has signed an agreement with MC2 Therapeutics to commercialize Wynzora® Cream in Canada through its subsidiary Paladin Pharma.

When was Wynzora® Cream approved in the US and Europe?

Wynzora® Cream received FDA approval on July 20, 2020, and was launched in Europe on February 18, 2022.

What condition does Wynzora® Cream treat?

Wynzora® Cream is designed to treat plaque psoriasis.

Has Wynzora® Cream been approved in Canada?

No, Wynzora® Cream is currently pending approval from Health Canada.

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