Endo Announces Agreement for Paladin Labs to Develop, Commercialize and Supply Quoin Pharmaceuticals' QRX003 in Canada

The product is under investigation for the treatment of Netherton syndrome, a rare disease

DUBLIN, July 15, 2022 /CNW/ -- Endo International plc (NASDAQ: ENDP) announced today that its subsidiary Endo Ventures Limited has entered into agreements with Quoin Pharmaceuticals Inc. (NASDAQ: QNRX) for the development, registration, supply, commercialization and distribution of QRX003 on an exclusive basis in Canada. If the product is approved, Paladin Labs Inc., an operating company of Endo, will be responsible for all commercial activities in Canada.

QRX003 is Quoin's lead product for Netherton syndrome. Netherton syndrome, a form of ichthyosis, is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene (serine protease inhibitor, Kazal Type 5) that leads to severe skin barrier defects and recurring infections, as well as a pronounced predisposition to allergies, asthma and eczema. Patients also often suffer from severe dehydration, chronic skin inflammation and stunted growth.¹

There is currently no cure or satisfactory treatment option available for Netherton syndrome.²

"We're pleased to help bring this potential treatment to appropriate pediatric patients," said Livio Di Francesco, Vice President and General Manager of Paladin. "One of our company's strategic priorities is to be a force for good, and we hope that QRX003 can help families coping with this rare disease."

Paladin currently expects to launch the product in 2025 in Canada.

About Endo and Paladin Labs

Endo (NASDAQ: ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.

Paladin Labs 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 and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo International plc. For more information visit: www.endo.com or www.paladin-labs.com.

About Quoin Pharmaceuticals Inc.

Quoin Pharmaceuticals Inc. is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.

Cautionary Note Regarding Forward-Looking Statements

Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation including, but not limited to, the statements by Mr. Di Francesco and any statements relating to the development, registration, supply, commercialization, distribution or launch of products. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this press release reflect Endo's current expectations of future events based on existing trends and information and represent Endo's judgment only as of the date of this press release. Actual results may differ materially and adversely from current expectations based on a number of factors affecting Endo's businesses, including, among other things, the following: the outcome of our strategic review, contingency planning and any potential restructuring; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust matters; actual or contingent liabilities; settlement discussions or negotiations; the impact of competition including loss of exclusivity and generic competition; our ability to satisfy judgments or settlements or to pursue appeals including bonding requirements; our ability to adjust to changing market conditions; our inability to maintain compliance with financial covenants and operating obligations which would expose us to potential events of default under our outstanding indebtedness; our ability to incur additional debt or refinance our outstanding indebtedness; and a significant reduction in our short-term or long-term revenues which could cause us to be unable to fund our operations and liquidity needs. The occurrence or possibility of any such result has caused us to engage, and may result in further engagement, in strategic reviews that ultimately may result in our pursuing one or more significant corporate transactions or other remedial measures, including on a preventative or proactive basis. Those remedial measures could include a potential corporate reorganization, restructuring or bankruptcy filing involving all or a portion of our business, asset sales or other divestitures, cost-saving initiatives, corporate realignments or strategic partnerships. Some of these measures could take significant time to implement and others may require judicial or other third-party approval. Any such actions may be complex, could entail significant costs and charges or could otherwise negatively impact shareholder value, and there can be no assurance that we will be able to accomplish any of these alternatives on terms acceptable to us, or at all, or that they will result in their intended benefits. Therefore, the reader is cautioned not to rely on any forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission.

References:

1. Genetic and Rare Diseases Information Center. (November 2021). Netherton syndrome. U.S. Department of Health and Human Services. https://rarediseases.info.nih.gov/diseases/7182/netherton-syndrome. Accessed on July 1, 2022.
2. Saleem H, Shahid M, Shahbaz A, et al. (July 30, 2018) Netherton Syndrome: A Case Report and Review of Literature. Cureus 10(7): e3070. DOI 10.7759/cureus.3070

SOURCE Endo International plc

Media: Heather Zoumas-Lubeski, [phone], [email protected]; Investors: Laure Park, [phone], [email protected]