Endo Announces First Patient Enrolled in Registry of Peyronie's Disease

DUBLIN, July 20, 2023 /CNW/ -- Endo International plc (OTC: ENDPQ) announced today that the first patient has been enrolled in CURVE-PD (Clinical Understanding through Real-world data to Validate Effectiveness of treatments in Peyronie's disease), a non-interventional registry of up to 1,000 patients with Peyronie's disease (PD). This registry will create the largest and most comprehensive collection of real-world PD data on treatment outcomes.

PD is a men's health condition that is estimated to affect 1 in 10 men in the U.S.* and can lead to a curvature deformity of the penis when erect.

"We're pleased to help advance knowledge of Peyronie's disease and treatments so that, in the future, patients can benefit from a fuller understanding of their options," said Gregory Kaufman, M.D., Vice President, Medical Affairs and Chief Medical Officer at Endo. "Along with our study steering committee partners, Endo is committed to supporting the Peyronie's patient community."

"Because Peyronie's disease is not a life-threatening disease and due to embarrassment about the condition, many people with Peyronie's may not seek medical attention, which has led to insufficient data on the condition," said Dr. Mohit Khera, M.D., President of the Sexual Medicine Society of North America. "This landmark registry will facilitate more comprehensive knowledge of treatment and management using real-world evidence."

The Study is run by a steering committee that consists of Dr. Mohit Khera, President of the Sexual Medicine Society of North America and Professor of Urology at Baylor College of Medicine; Dr. Jesse Mills, Director of Urology at UCLA Santa Monica Medical Center; and Dr. Ranjith Ramasamy, Director of Reproductive Urology and Associate Professor of Clinical Urology at University of Miami, as well as representatives from Endo and Pulse Infoframe, including Pulse CEO Femida Gwadry-Sridhar, R.Ph., Ph.D.

* Based on a survey of about 7,700 U.S. adult men with a PD diagnosis, PD-related symptoms or a history of seeking treatment for the condition.

About the Study
CURVE-PD (NCT05873595) is a non-interventional study of up to 1,000 PD patients from 15 sites who have initiated treatment within two weeks before, at or any time after the date of enrollment. Patients will be followed for up to one year, and data will be collected from the patients, their healthcare providers and their partners.

Patients will answer questions related to, but not limited to, reasons for treatment choice, self-measurement of curve before and after treatments; ability to participate in sexual activities before and after treatment; in-home stretching/modeling to complement in-office procedures; satisfaction, depression and anxiety scales, including the Peyronie's Disease Questionnaire (PDQ); and patient and partner satisfaction.

Healthcare providers will answer questions related to, but not limited to, reasons for treatment choice, details of treatment, length and curve of penis before and after treatment and location of plaque treated.

About Peyronie's Disease
Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature deformity of the penis. This curvature can be painful during arousal and intimacy. PD can affect as many as 1 in 10 men in the U.S., but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.

About Endo
Endo (OTC: ENDPQ) 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 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.

About Pulse Infoframe
Pulse Infoframe is a real-world evidence generation, health informatics, and insights company that has built a structured technology and services platform designed to extract, curate, analyze, and disseminate evidence-based conclusions that improve the quality of people's lives. Pulse Infoframe provides a full solution for registries, natural history studies, and other observational and regulatory grade studies. With provider relationships for patient access, Pulse Infoframe ensures that insights, evidence, and publication results are disseminated across the ecosystem, including advocacy organizations, key opinion leaders, researchers, and sponsors. Learn more at www.pulseinfoframe.com.

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 Drs. Kaufman and Khera, any statements relating to product efficacy, clinical trials or studies, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "intend," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the outcome of the Company's contingency planning and restructuring activities; the timing, impact or results of any pending or future litigation, investigations, proceedings or claims, including opioid, tax and antitrust related matters; any actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the risks and uncertainties associated with chapter 11 proceedings; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the risk that the Company's chapter 11 cases may be converted to cases under chapter 7 of the Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results; the Company's ability to discharge claims in chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; the risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in chapter 11 proceedings; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; and the Company's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. The Company 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 the Company, as well as the Company'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 the Company'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.

SOURCE Endo International plc

Endo International plc: Media: Linda Huss, [email protected] or Investors: Laure Park, [email protected]