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Xeomin® (IncobotulinumtoxinA) Celebrates 10 Years of Meeting the Needs of Patients Suffering from Movement Disorders

Merz Therapeutics is commemorating today the 10th anniversary of the first therapeutic approval of XEOMIN by the U.S. Food and Drug Administration. XEOMIN now holds four first-line therapeutic indications in the U.S. with a sustained commitment to improving the lives of adult patients with movement disorders and other neurological conditions (upper limb spasticity, cervical dystonia, blepharospasm and chronic sialorrhea).

“We are proud to celebrate a decade of XEOMIN, a first-line uniquely purified neuromodulator, and its impact on patients, caregivers and the movement disorder community,” said Kevin O’Brien, President of North America, Merz Therapeutics. “This a significant milestone for XEOMIN and comes off the heels of our recent establishment of Merz Therapeutics as a standalone global business solely dedicated to addressing the unmet needs of our therapeutic patients around the world.”

On July 30, 2010, XEOMIN was first approved in the U.S. for cervical dystonia and blepharospasm in adult patients. Five years later, its approvals were expanded to include the treatment of adult patients with upper limb spasticity. In a bold move to serve more than 600,000 adults, XEOMIN became the first and only U.S. FDA-approved botulinum toxin type A for the treatment of chronic sialorrhea in adults. In addition to its robust clinical pipeline, Merz Therapeutics offers Merz Connect™ – a dedicated resource comprised of patient assistance and patient savings programs. Over the last several years, Merz Connect has continued to support patient access to needed therapy by increasing its level of support for out-of-pocket expenses for the thousands of patients enrolled across these programs.

“I trust XEOMIN, because I care about the long-term health of my patients and the potential impact of immunogenicity from their treatments,” said John McGuire, M.D., Professor Department of Physical Medicine and Rehabilitation, Medical College of Wisconsin & Froedtert Hospital. “It is clinically proven that patients treated with XEOMIN have not developed clinical resistance due to neutralizing antibodies. As a physician, I trust data and science, so I choose XEOMIN for my patients.”

XEOMIN was first approved in 2005 in Germany for the treatment of cervical dystonia and blepharospasm and has since expanded to more than 70 countries treating more than three million patients. “We’re ready for the next decade of innovation with XEOMIN in the U.S. and beyond,” said Stefan Brinkmann, Global CEO, Merz Therapeutics. “In July, we completed a partnership to market XEOMIN in Japan and we have more exciting opportunities ahead of us. I’m looking forward to continuing to help patients around the world have access to a pure, safe and effective treatment like XEOMIN.”

XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

  • Talk to your health care provider or pharmacist
  • Visit www.xeomin.com to obtain the FDA-approved product labeling
  • Call 1-844-4MYMERZ

Uses
XEOMIN is a prescription medicine used in adults:

  • that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).
  • that is injected into muscles and used to:
    • treat increased muscle stiffness in the arm because of upper limb spasticity.
    • treat the abnormal head position and neck pain with cervical dystonia (CD).
    • treat abnormal spasm of the eyelids (blepharospasm) in adults.

It is not known if XEOMIN is safe and effective in children under 18 years of age.

Warnings
XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:

  • Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
    • People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
    • Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
  • Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

  • have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)
  • have had any side effect from any other botulinum toxin in the past
  • have a breathing problem such as asthma or emphysema
  • have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
  • have bleeding problems
  • have drooping eyelids
  • have plans to have surgery
  • have had surgery on your face
  • are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.

Using XEOMIN with certain other medicines may cause serious side effects Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past.
Especially tell your doctor if you:

  • have received any other botulinum toxin product in the last four months
  • have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
  • have recently received an antibiotic by injection
  • take muscle relaxants
  • take an allergy or cold medicine
  • take a sleep medicine

Ask your doctor if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Possible Side Effects
XEOMIN can cause serious side effects including:
See “Warnings.”

• Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN.
• XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

The most common side effects of XEOMIN in people with chronic sialorrhea include:
• needing to have a tooth pulled (extracted)
• dry mouth
• diarrhea
• high blood pressure

The most common side effects of XEOMIN in people with upper limb spasticity include:
• seizure
• nasal congestion, sore throat and runny nose
• dry mouth
• upper respiratory infection

The most common side effects of XEOMIN in people with cervical dystonia include:
• difficulty swallowing
• neck pain
• muscle weakness
• pain at the injection site
• muscle and bone pain

The most common side effects of XEOMIN in people with blepharospasm include:
• drooping of the eyelid
• dry eye
• vision problems
• dry mouth

These are not all the possible side effects of XEOMIN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

General information about the safe and effective use of XEOMIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

Active Ingredient: botulinum toxin type A
Inactive Ingredients: human albumin and sucrose

Copyright © 2020 Merz Pharmaceuticals, LLC. All rights reserved. MERZ, the MERZ logo, and
XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. Botox, Dysport and
Myobloc are registered trademarks of their respective owners.

For more information, please see XEOMIN full Prescribing Information and Medication Guide at www.xeomin.com.

Press Contact

Merz North America

Jane Yarbrough
Corporate Communications

 

Phone: +1.984.218.0983

Merz Therapeutics

Merz Therapeutics, a business of Merz Pharmaceuticals GmbH, is a global healthcare leader dedicated to improving the lives of patients around the world. With our relentless research, development, and culture of innovation, we strive to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions and other health conditions that severely impact patients’ quality of life. Merz Therapeutics is headquartered in Frankfurt, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Pharmaceuticals GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 110 years to developing innovations that meet patient and customer needs.