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ENDO INTERNATIONAL PLC

(ENDP)
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Endo International : Announces First-Ever XIAFLEX« (collagenase clostridium histolyticum) Television Commercial, Bent Carrot, and Branded Campaign to Raise Awareness of Peyronie's Disease

10/25/2021 | 07:01am EST

DUBLIN, Oct. 25, 2021 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) announced today the launch of their first-ever XIAFLEX® (collagenase clostridium histolyticum) television commercial, Bent Carrot. The spot introduces men to XIAFLEX as the first and only nonsurgical FDA-approved treatment for Peyronie's disease (PD) and encourages them to seek treatment if they believe they may have the condition, in which a buildup of fibrous scar tissue (plaque) causes a curvature of the penis.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8968051-endo-first-ever-xiaflex-collagenase-clostridium-histolyticum-manhood-campaign-peyronies-disease/

"We're bringing awareness and education about treatment to consumers—part of Endo's long-standing commitment to addressing men's health issues," said Thomas Kolaras, Senior Vice President & General Manager, Medical Therapeutics at Endo. "Through this eye-catching, multi-channel campaign, we're encouraging men with possible signs of Peyronie's disease to start a conversation with a urologist about their symptoms and about whether XIAFLEX could be an option."

"My patients with PD had to overcome many challenges to finally find a doctor and discuss their condition—embarrassment, denial, fear and a host of other internal and external factors," said Dr. Jesse Mills, Associate Clinical Professor and Division Chief of Andrology at UCLA. "In my opinion, Endo's clever carrot campaign succeeds in educating more men about PD and continues to normalize and destigmatize the condition. I look forward to seeing current and future patients empowered by Endo's commitment to men's health."

Patient Insight
Over the last two years, Endo has gathered insights via market research from men living with PD. For these men, the journey from diagnosis to treatment can take upward of seven years. Often, men are misdiagnosed and/or are frustrated by their journey to address their erectile curvature.

Integrated Campaign Details
The 60-second TV commercial features the image of a bent carrot to symbolize PD. It will run on prime-time TV (including networks like USA and news programs such as "CBS Evening News with Norah O'Donnell"), streaming services (including Hulu, Paramount+ and Discovery+) and online beginning in October.

The commercial is part of a larger, surround-sound campaign that includes radio and streaming music service ads, social media ads on platforms where patients are active, digital ads and partnerships on health-focused websites, signage and educational materials in doctors' offices and partnerships with industry organizations.

Why the carrot? It's a friendly, visual approach to a condition that often causes embarrassment and may feel too intimate to discuss. The single, simple metaphor is memorable and easy to recall. The campaign uses positive and lively—but not funny—creative to visualize PD in a way that's factual, understandable and solution-oriented.

About Peyronie's Disease
Peyronie's disease (PD) is a condition in which a buildup of fibrous scar tissue causes a curvature 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.

For additional information and helpful and educational content—including the "Find a Urologist" tool—visit xiaflex.com/pd.

XIAFLEX® (collagenase clostridium histolyticum)
IMPORTANT SAFETY INFORMATION

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-the- counter 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)

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 International plc
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.

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. Kolaras and Dr. Mills and any statements relating to product efficacy, adverse reactions, product potential, sales, supply or availability. All forward-looking statements in this press release reflect Endo's current expectations of future events based on information available to Endo as of the date of this press release. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo's expectations and projections, including with respect to the impact of any litigation, investigation or settlement proceeding on our financial statements, including our cash flows from operations; our ability to adjust to changing market conditions; our ability to attract and retain key personnel; our ability to maintain compliance with our financial obligations under certain of our outstanding debt obligations, causing a downgrade of our debt and long-term corporate ratings (which could increase our cost of capital) and exposing us to potential events of default (if not cured or waived) under financial and operating covenants contained in our or our subsidiaries' outstanding indebtedness; our ability to incur additional borrowings under the covenants in our then-existing facilities or to obtain additional debt or equity financing for working capital, capital expenditures, business development, debt service requirements, acquisitions or general corporate or other purposes, or to refinance our indebtedness; and/or a significant reduction in our short-term and long-term revenues and/or otherwise cause us to be unable to fund our operations and liquidity needs, such as future capital expenditures and payment of our indebtedness. The occurrence or possibility of any such result may cause us to pursue one or more significant corporate transactions or remedial measures, including on a preventative or proactive basis. Actions that may be evaluated or pursued could include reorganization or restructuring activities of all or a portion of our business, asset sales or other divestitures, cost-saving initiatives or other corporate realignments, seeking strategic partnerships and exiting certain product or geographic markets. 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. Other risks and uncertainties include general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Endo's periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K.

Endo International plc:


Media:

Investors:

Heather Zoumas-Lubeski

Pravesh Khandelwal

(484) 216-6829

(845) 364-4833

media.relations@endo.com

relations.investor@endo.com

 

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View original content:https://www.prnewswire.com/news-releases/endo-announces-first-ever-xiaflex-collagenase-clostridium-histolyticum-television-commercial-bent-carrot-and-branded-campaign-to-raise-awareness-of-peyronies-disease-301407038.html

SOURCE Endo International plc


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