Endo Launches Unscripted Video Series With Real Peyronie's Disease Patients

USA - English

• USA - English

"PD Pool Hall" Explores the Men's Health Condition Through Real Patients and Real Talk

• Unscripted videos feature real Peyronie's disease (PD) patients discussing their experiences while shooting pool
• Though PD is a relatively common condition, diagnosis rates remain low because men with PD may be uncomfortable to speak up and get help
• "PD Pool Hall" videos are available online now and through digital and social advertising beginning in December

DUBLIN, Nov. 30, 2023 /CNW/ -- Endo International plc (OTC: ENDPQ) announced today the launch of its new branded video series, PD Pool Hall, which aims to educate people about Peyronie's disease (PD), 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.

The PD Pool Hall videos feature four real patients, both treated and untreated, in a pool hall discussing their experiences with PD, including the impact on their lives and their treatment journeys. The conversations are unscripted and present the patients' actual views and stories.

"The most knowledgeable person to talk to about Peyronie's is a specialized urologist, and the most relatable and empowering person is someone who has had PD themselves," said Justin Mattice, Vice President & General Manager, Branded Specialty at Endo.

"The men in the videos know firsthand the confusion, embarrassment and even fear that men may face along the PD journey," Mattice continued. "Their authentic stories help to normalize the conversation around men's health and can motivate others who think that they may have PD to talk to a urologist about treatment options, including XIAFLEX^® (collagenase clostridium histolyticum), the only FDA-approved nonsurgical treatment for PD." XIAFLEX should not be used if the Peyronie's plaque to be treated involves the urethra.

The videos are viewable on Endo's newly redesigned consumer website for XIAFLEX, found at XIAFLEX.com. They will be used in digital and social advertising, beginning next month.

* 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 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.¹ It is estimated that PD can affect as many as 1 in 10 men in the U.S.,² but diagnosis rates remain low because men with PD may be too uncomfortable to speak up and get help.³

What is XIAFLEX^®?

XIAFLEX is a prescription medicine used to treat adult men with Peyronie's disease who have a "plaque" that can be felt and a curve in their penis greater than 30 degrees when treatment is started.

It is not known if XIAFLEX is safe and effective in children under the age of 18.

IMPORTANT SAFETY INFORMATION

Do not receive XIAFLEX if:

• the Peyronie's plaque to be treated involves the "tube" that your urine passes through (urethra).
• you are allergic to collagenase clostridium histolyticum or any of the ingredients in XIAFLEX, or to any other collagenase product. See the end of the Medication Guide for a complete list of ingredients in XIAFLEX.

XIAFLEX can cause serious side effects, including:

1.    Penile fracture (corporal rupture) or other serious injury to the penis. Receiving an injection of XIAFLEX may cause damage to the tubes in your penis called the corpora. After treatment with XIAFLEX, one of these tubes may break during an erection. This is called a corporal rupture or penile fracture. This could require surgery to fix the damaged area. Damage to your penis might not get better after a corporal rupture.

• After treatment with XIAFLEX, blood vessels in your penis may also break, causing blood to collect under the skin (hematoma). This could require a procedure to drain the blood from under the skin. If a hematoma appears, skin and soft tissue necrosis (death of skin cells) may develop in that area, which could require surgery.

Symptoms of corporal rupture or other serious injury to your penis may include:

• a popping sound or sensation in an erect penis
• sudden loss of the ability to maintain an erection
• pain in your penis
• purple bruising and swelling of your penis
• difficulty urinating or blood in the urine

Call your healthcare provider right away if you have any of the symptoms of corporal rupture or serious injury to the penis listed above.

Do not have sex or any other sexual activity between the first and second injections of a treatment cycle.

Do not have sex or have any other sexual activity for at least 4 weeks after the second injection of a treatment cycle with XIAFLEX and after any pain and swelling has gone away.

XIAFLEX for the treatment of Peyronie's disease is only available through a restricted program called the XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program.

2.    Hypersensitivity reactions, including anaphylaxis. Severe allergic reactions can happen in people who receive XIAFLEX, because it contains foreign proteins.

Call your healthcare provider right away if you have any of these symptoms of an allergic reaction after an injection of XIAFLEX:

• hives
• swollen face
• breathing trouble
• chest pain
• low blood pressure
• dizziness or fainting

3.    Back pain reactions. After receiving an injection of XIAFLEX for Peyronie's disease, you may suddenly feel back pain, including severe lower back pain moving to your legs, feet, chest and arms. The back pain may also include spasms and make it hard to walk. These symptoms usually go away in 15 minutes or less, but may last longer.

Tell your healthcare provider right away if you have sudden back pain, chest pain, or hard time walking after an injection.

Before receiving XIAFLEX, tell your healthcare provider if you have had an allergic reaction to a previous XIAFLEX injection, have a bleeding problem, received XIAFLEX for another condition, or any other medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Using XIAFLEX with certain other medicines can cause serious side effects. Especially tell your healthcare provider if you take medicines to thin your blood (anticoagulants). If you are told to stop taking a blood thinner before your XIAFLEX injection, your healthcare provider should tell you when to restart the blood thinner. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

What should I avoid while receiving XIAFLEX?

Avoid situations that may cause you to strain your stomach (abdominal) muscles, such as straining during bowel movements. Do not use a vacuum erection device during your treatment with XIAFLEX. XIAFLEX can cause serious side effects, including increased chance of bleeding. Bleeding or bruising at the injection site can happen in people who receive XIAFLEX. Talk to your healthcare provider if you have a problem with your blood clotting. XIAFLEX may not be right for you.

The most common side effects with XIAFLEX for the treatment of Peyronie's disease include:

• a small collection of blood under the skin at the injection site (hematoma)
• swelling at the injection site or along your penis
• pain or tenderness at the injection site, along your penis and above your penis
• penis bruising
• itching of your penis or scrotum (genitals)
• painful erection
• erection problems (erectile dysfunction)
• changes in the color of the skin of your penis
• blisters at the injection site
• pain with sex
• a lump at the injection site (nodule)

Events of fainting (passing out) and near fainting have been reported by some patients treated with XIAFLEX.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with XIAFLEX. For more information, ask your healthcare provider or pharmacist.

Click for full Prescribing Information, including Boxed Warning and Medication Guide.

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.

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. Mattice, any statements relating to product efficacy, 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," "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.

References:

1. Hellstrome WJ. Int J Impot Res. 2003;15:S91-S92.
2. Stuntz M, Perlaky A, des Vignes F, et al. PLoS One. 2016;11(2):e0150157.
3. DiBenedetti DB, Nguyen D, Zografoset L, al. Adv Urol. 2011:282503

SOURCE Endo International plc

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