Data from Merz Aesthetics’ Post-Market Clinical Study of Xeomin® (incobotulinumtoxinA) vs. Botox® (onabotulinumtoxinA) for Glabellar Facial Lines Published in Dermatologic Surgery

RALEIGH, N.C.–(BUSINESS WIRE)–Merz
Aesthetics
, a division of Merz North America (U.S. affiliate of the
global Merz Pharma Group), today announced that the medical journal “Dermatologic
Surgery
“ (Wolters Kluwer) has published data from its post-market,
prospective parallel group clinical trial evaluating the efficacy of Xeomin®
(incobotulinumtoxinA)
in the treatment of moderate to severe glabellar facial lines, when
compared to Botox® Cosmetic (onabotulinumtoxinA). The article
titled “A
Randomized, Double-Blind Trial to Investigate the Equivalence of
IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines“

is now available in the November 2015 issue of the journal.


Dermatologic Surgery’s publication of this new clinical data
demonstrating the efficacy of Xeomin® (incobotulinumtoxinA)
will prove critical in encouraging physicians to consider Xeomin®
(incobotulinumtoxinA) for their patients as an effective treatment for
glabellar lines,“ said Jim Hartman, Vice President and U.S. Head – Merz
Aesthetics Injectables. “Merz remains committed to delivering a better
total experience in aesthetics, and we are proud to offer patients and
physicians a full palette of treatment options across the aesthetic
device, injectables and skincare categories.”

Clinical trial results show that this parallel group study met its
primary efficacy endpoint of clinical equivalence, defined as ≥ 1-point
improvement from baseline on the Facial Wrinkle Scale (FWS) at maximum
frown, 1 month after a single treatment. Similar efficacy and
tolerability profiles were demonstrated between the two treatment groups
at all timepoints (1, 2, 3 and 4 months post-treatment). The most common
adverse events seen in both treatment groups were headache, infection
and facial asymmetry.

“As the first large, randomized, multicenter direct comparator study to
date using the FDA recommended dose of 20 units, this trial represents
the definitive U.S. comparison study of Xeomin®
(incobotulinumtoxinA) versus Botox® (onabotulinumtoxinA) for
the treatment of glabellar facial lines. These study results further
confirm the literature demonstrating similar efficacy and safety
profiles for both products,“ stated Dr.
Michael Kane, MD
, co-principal investigator of the study. A
board-certified plastic surgeon in private practice in Manhattan, NY,
Dr. Kane frequently lectures on topics relating to aesthetic plastic
surgery and has published hundreds of papers throughout his career.

Botulinum toxin type A is a well-established treatment for glabellar
frown lines. In 2011, Xeomin® (incobotulinumtoxinA) was
approved by the FDA for improvement in the appearance of
moderate-to-severe glabellar frown lines with a recommended dosage of 20
units (U). Head-to-head comparison studies conducted worldwide have
demonstrated that treatment with Xeomin®
(incobotulinumtoxinA) and Botox® (onabotulinumtoxinA) result
in comparable safety and efficacy for both cosmetic use and therapeutic
uses, including blepharospasm and cervical dystonia.1

This
manuscript was published in the November 2015 issue of Dermatologic
Surgery
and is now available online
and in print.

About Xeomin® (incobotulinumtoxinA)

XEOMIN® (incobotulinumtoxinA) is a prescription medicine that
is injected into muscles and used to temporarily improve the look of
moderate to severe frown lines between the eyebrows (glabellar lines) in
adults.

About Merz Aesthetics Injectables

Merz Aesthetics is a division of Merz North America, a specialty
healthcare company that is dedicated to delivering a better total
experience in aesthetics, dermatology and neurosciences. In the
Injectables category, Merz Aesthetics delivers a strong portfolio of
products that is trusted by patients and expert practitioners alike. By
providing a palette of options, Merz Aesthetics Injectables seeks to
help physicians to focus on choosing and applying technologies that
result in the desired outcome for their patients. The Merz Aesthetics
Injectables portfolio includes the neurotoxin Xeomin®
(incobotulinumtoxinA), the dermal filler Belotero Balance®
and the family of Radiesse® products.

To learn more about Merz Aesthetics and their Injectables offerings,
please visit www.merzusa.com/aesthetics-otc.

XEOMIN® IMPORTANT SAFETY INFORMATION

Read this Medication Guide before you start receiving XEOMIN® 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.xeominaesthetic.com
    to obtain the FDA-approved product labeling
  • Call 1-866-862-1211

Uses XEOMIN® is a prescription medicine that is injected into
muscles and used to improve the look of moderate to severe frown lines
between the eyebrows (glabellar lines) in adults for a short period of
time (temporary).

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 week) after
treatment with XEOMIN
®:

  • Problems with swallowing, speaking, or breathing. These
    problems can happen hours to weeks after an injection of XEOMIN
    ®
    if the muscles that you use to breathe and swallow become weak after
    the injection. 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. These patients may be at greater risk
    for serious breathing problems with XEOMIN®.
  • Swallowing problems may last for several months. People who cannot
    swallow well 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 problems could make it unsafe for you to drive a car or do other
dangerous activities.

Active Ingredient

Purpose

incobotulinumtoxinA…………acts on nerve endings in muscles to prevent
muscle fibers from contracting

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

Ask a doctor before use 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 allergies to any botulinum toxin product
  • 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.

XEOMIN is not recommended for use in children younger than 18 years of
age.

Tell your doctor about all of your medical conditions and all of
the medicines you take, including prescription and nonprescription
medicines, vitamins and herbal supplements. 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
  • take a blood thinner medicine

Ask your doctor if you are not sure if your medicine is one that is
listed above.

Possible Side Effects

XEOMIN can cause serious side effects that can be life threatening.
See “Warnings.”

Headache was the most common side effect of XEOMIN for treatment of
glabellar lines. Other possible side effects include:

  • dry mouth
  • discomfort or pain at the injection site
  • tiredness
  • neck pain
  • muscle weakness
  • eye problems, including: double vision, blurred vision, drooping
    eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can
    also occur. Tell your doctor or get medical help right away if you
    have eye pain or irritation following treatment.

XEOMIN may cause other serious side effects including allergic
reactions. Symptoms of an allergic reaction to XEOMIN®
may include: itching, rash, redness, swelling, wheezing, asthma
symptoms, or dizziness or feeling faint. Tell your doctor or get medical
help right away if you get wheezing or asthma symptoms, or if you get
dizzy or faint.

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

These are not all the possible side effects of XEOMIN®. For
more information, talk to your doctor.

Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.

Directions

  • XEOMIN® is a shot (injection) that your doctor will
    give you.
  • XEOMIN® is injected into your affected muscles.
  • Your doctor may change your dose of XEOMIN® until
    you and your doctor find the best dose for you.

Inactive Ingredients human albumin and sucrose

XEOMIN and BELOTERO are registered trademarks and Merz Aesthetics is a
registered trademark of Merz Pharma GmbH & Co. KGaA. RADIESSE is a
registered trademark of Merz North America, Inc.

Botox®, Dysport® and Myobloc® are
registered trademarks of their respective owners.

1 Data on file

Contacts

Merz North America
Mariana Smith Bourland
Corporate
Communications
336-339-0172, Mariana.Smith@merz.com