FORT WORTH, Texas and
PLEASANTON, Calif., Dec. 8, 2015 /PRNewswire/ -- Galderma, a
global leader in skin health, and ZELTIQ® Aesthetics, Inc. (Nasdaq:
ZLTQ), a medical technology company focused on developing its
proprietary controlled-cooling technology platform, today announced
a new collaboration across the companies' innovative aesthetic
brands and offerings. Effective immediately, the creation of
this nationwide collaboration between two of the fastest-growing
companies in the aesthetic space will provide healthcare
professionals and consumers with greater access to a robust range
of technologically-advanced and scientifically-proven beauty
solutions for facial rejuvenation and non-invasive fat
reduction.
Galderma markets leading aesthetic brands including Dysport®
(abobotulinumtoxinA), for temporary improvement in the look of
moderate to severe frown lines between the eyebrows (glabellar
lines); the newly launched Restylane® Silk, the first product
specifically designed to treat the lips and lines around the mouth;
Restylane® Lyft, the first and only FDA-approved filler indicated
to provide fullness to the midface area (cheeks) and correct and
smooth the nasolabial folds ("smile lines"); and Sculptra®
Aesthetic, a long-acting dermal filler, which stimulates natural
collagen production, helping to increase the elasticity of the skin
and smooth out deep wrinkles and folds.
ZELTIQ brings the world's number one non-invasive fat reduction
procedure, CoolSculpting®, to the new collaboration. The
breakthrough procedure safely and effectively reduces unwanted fat
without surgery or downtime using a patented cooling technology.
Millions of CoolSculpting treatments have been performed
worldwide.
In addition, the two companies will create connections between
the Galderma portfolio of aesthetic brands and ZELTIQ's
CoolSculpting procedure for healthcare professionals and consumers
through their respective industry-leading loyalty programs: ASPIRE
Galderma Rewards loyalty program (www.aspirerewards.com) and
Crystal Rewards (www.coolsculpting.com).
"The collaboration between Galderma and ZELTIQ is extremely
exciting and will provide value to my practice and patients," said
Grant Stevens, MD, FACS, a
board-certified plastic surgeon in California. "For many years, I have used and
trusted Galderma aesthetic brands and ZELTIQ's CoolSculpting. I am
pleased this collaboration will result in greater access to these
valuable products, as well as added benefits for my practice and
patients through the ASPIRE Galderma Rewards and Crystal Rewards
loyalty programs."
"Galderma's aesthetic brands and ZELTIQ's CoolSculpting are some
of the most popular aesthetic procedures performed in my practice,"
said Jody Comstock, MD, a
board-certified dermatologist in Arizona. "This collaboration is great news for
healthcare specialists and consumers alike and demonstrates
Galderma's and ZELTIQ's commitment to the aesthetics market."
"At Galderma, we are focused on advancing skin health and
driving category innovation for natural looking results. Through
this uniquely-designed collaboration with ZELTIQ, we are bringing
together leading facial aesthetic technology and non-invasive fat
reduction to better serve and provide long-term value to our
healthcare specialists, as well as increase awareness among
consumers," said Kelly Huang, PhD,
Vice President and General Manager, Aesthetic and Corrective
Business Unit, Galderma, U.S.
"ZELTIQ has revolutionized non-invasive fat reduction, as
demonstrated by both physicians and consumers embracing
CoolSculpting and making it the market leader. We are thrilled to
collaborate with Galderma, a company that also has strong
relationships in and a deep commitment to the aesthetic category,"
said Mark Foley, President and Chief
Executive Officer of ZELTIQ. "Our shared goal in this collaboration
is to combine innovation and technology with relationships to
create an extraordinary offering for healthcare professionals and
consumers."
Galderma and ZELTIQ plan to initiate a joint educational effort,
as well as market growth strategies to benefit both healthcare
providers and consumers.
About Galderma
Dating back to 1961, Galderma is now present in 80 countries
with an extensive product portfolio to treat a range of
dermatological conditions. The company partners with health care
professionals around the world to meet the skin health needs of
people throughout their lifetime. Galderma is a leader in research
and development of scientifically-defined and medically-proven
solutions for the skin, hair and nails.
Strategic brands in the U.S. include Epiduo® Gel, Oracea®
Capsules, Clobex® Spray, Differin® Gel, Mirvaso® Gel, MetroGel®
Gel, Soolantra® Cream, Vectical® Cream, Tri-Luma® Cream, Cetaphil®,
Benzac® Acne Solutions, Excipial® Skin Solutions, Restylane®,
Restylane® Silk, Restylane® Lyft, Dysport® (abobotulinumtoxinA) and
Sculptra® Aesthetic. For more information, please visit
www.galderma.com and www.galdermausa.com.
About ZELTIQ
ZELTIQ® is a medical technology company focused on
developing and commercializing products utilizing its proprietary
controlled-cooling technology platform. ZELTIQ's first
commercial product, the CoolSculpting® system, is designed to
selectively reduce unwanted fat that may not respond to diet or
exercise. The CoolSculpting procedure is based on the scientific
principle that fat cells are more sensitive to cold than the
overlying skin and surrounding tissues. It utilizes patented
technology of precisely controlled cooling to reduce the
temperature of fat cells in the treated area, which is intended to
cause fat cell elimination through a natural biological process
known as apoptosis. ZELTIQ developed CoolSculpting to safely,
noticeably, and measurably reduce the fat layer.
All trademarks are the property of their respective owners.
Dysport Important Safety Information
Dysport is an acetylcholine release inhibitor and a
neuromuscular blocking agent indicated for the temporary
improvement in the appearance of moderate to severe glabellar lines
associated with procerus and corrugator muscle activity in adult
patients less than 65 years of age.
Distant Spread of Toxin Effect
Postmarketing reports indicate that the effects of
Dysport and all botulinum toxin products may spread from the
area of injection to produce symptoms consistent with botulinum
toxin effects. These may include asthenia, generalized muscle
weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia,
dysarthria, urinary incontinence and breathing difficulties. These
symptoms have been reported hours to weeks after injection.
Swallowing and breathing difficulties can be life threatening and
there have been reports of death. The risk of symptoms is probably
greatest in children treated for spasticity but symptoms can also
occur in adults treated for spasticity and other conditions,
particularly in those patients who have underlying conditions that
would predispose them to these symptoms. In unapproved uses,
including spasticity in children and adults, and in approved
indications, cases of spread of effect have been reported at doses
comparable to those used to treat cervical dystonia and at lower
doses.
CONTRAINDICATIONS
- Dysport is contraindicated in patients with known
hypersensitivity to any botulinum toxin preparation or to any of
the components in the formulation.
- This product may contain trace amounts of cow's milk protein.
Patients known to be allergic to cow's milk protein should not be
treated with Dysport.
- Dysport is contraindicated for use in patients with
infection at the proposed injection site(s).
DOSAGE AND ADMINISTRATION
The potency Units of Dysport are specific to the
preparation and assay method utilized. They are not interchangeable
with other preparations of botulinum toxin products and, therefore,
units of biological activity of Dysport cannot be compared
to or converted into units of any other botulinum toxin products
assessed with any other specific assay method.
WARNINGS AND PRECAUTIONS
Facial Anatomy in the Treatment of Glabellar Lines
- Caution should be exercised when administering Dysport
to patients with surgical alterations to the facial anatomy,
excessive weakness or atrophy in the target muscle(s), marked
facial asymmetry, inflammation at the injection site(s), ptosis,
excessive dermatochalasis, deep dermal scarring, thick sebaceous
skin or the inability to substantially lessen glabellar lines by
physically spreading them apart.
- Do not exceed the recommended dosage and frequency of
administration of Dysport. In clinical trials, subjects who
received a higher dose of Dysport had an increased incidence
of eyelid ptosis.
Pre-existing Neuromuscular Disorders
- Individuals with peripheral motor neuropathic diseases,
amyotrophic lateral sclerosis or neuromuscular junction disorders
(e.g., myasthenia gravis or Lambert-Eaton syndrome) should be
monitored particularly closely when given botulinum toxin.
- Patients with neuromuscular disorders may be at increased risk
of clinically significant effects including severe dysphagia and
respiratory compromise from typical doses of Dysport.
Human Albumin
- This product contains albumin, a derivative of human blood.
Based on effective donor screening and product manufacturing
processes, it carries an extremely remote risk for transmission of
viral diseases.
- A theoretical risk for transmission of Creutzfeldt-Jakob
disease (CJD) is also considered extremely remote. No cases of
transmission of viral diseases or CJD have ever been reported for
albumin.
Intradermal Immune Reaction
- The possibility of an immune reaction when injected
intradermally is unknown.
- The safety of Dysport for the treatment of hyperhidrosis
has not been established.
ADVERSE REACTIONS
- In clinical studies, the most frequently reported adverse
events (≥2%) were nasopharyngitis, headache, injection site pain,
injection site reaction, upper respiratory tract infection, eyelid
edema, eyelid ptosis, sinusitis and nausea.
DRUG INTERACTIONS
- Patients treated concomitantly with botulinum toxins and
aminoglycosides or other agents interfering with neuromuscular
transmission (e.g., curare-like agents) should be observed closely
because the effect of the botulinum toxin may be potentiated. Use
of anticholinergic drugs after administration of Dysport may
potentiate systemic anticholinergic effects such as blurred
vision.
- The effect of administering different botulinum neurotoxin
products at the same time or within several months of each other is
unknown. Excessive weakness may be exacerbated by another
administration of botulinum toxin prior to the resolution of the
effects of a previously administered botulinum toxin.
- Excessive weakness may also be exaggerated by administration of
a muscle relaxant before or after administration of
Dysport.
USE IN SPECIFIC POPULATIONS
- Dysport is not recommended for use in children or
pregnant women.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see Dysport Full Prescribing Information including
Medication Guide.
Restylane Family Important Safety Information
Indications: The Restylane family of
products includes Restylane®,
Restylane-L®, Restylane® Silk,
Restylane® Lyft with Lidocaine, and
Perlane®. Restylane, Restylane-L,
Restylane Lyft with Lidocaine, and Perlane are
indicated for the correction of moderate to severe facial wrinkles
and folds, such as nasolabial folds. Restylane and
Restylane-L are indicated for mid-to-deep dermal
implantation. Perlane and Restylane Lyft with
Lidocaine are indicated for implantation into the deep dermis
to superficial subcutis. Restylane Silk is indicated for
submucosal implantation for lip augmentation and dermal
implantation for correction of perioral rhytids in patients over
the age of 21. Restylane Lyft with Lidocaine is also
indicated for cheek augmentation and for the correction of
age-related midface contour deficiencies in patients over the age
of 21. Restylane and Restylane-L are also indicated
for submucosal implantation for lip augmentation in patients over
the age of 21.
Products in the Restylane family contain traces of
gram-positive bacterial protein and are contraindicated for
patients with allergies to such material or in patients with severe
allergies that have required in-hospital treatment. These products
should not be used by patients with bleeding disorders or by
pregnant or breastfeeding women. Restylane and
Restylane-L for lip enhancement and Restylane Silk
should not be used by people under 22 years. Restylane-L,
Restylane Silk and Restylane Lyft with Lidocaine
should not be used by anyone with a known allergy to lidocaine.
Products should not be injected anywhere except the dermis,
superficial subcutis (Perlane and Restylane Lyft with
Lidocaine only), or lip submucosa (Restylane,
Restylane-L, and Restylane Silk only).
Use of products in the Restylane family at the site of
skin sores, pimples, rashes, hives, cysts, or infection should be
postponed until healing is complete. The most commonly observed
side effects are swelling, redness, pain, bruising, headache,
tenderness, and itching at the injection site. These are typically
mild in severity and typically resolve in less than 7 days. Serious
but rare side effects include delayed onset infections, recurrence
of herpetic eruptions, and superficial necrosis at the injection
site. Do not implant into blood vessels. Use with caution in
patients recently treated with anticoagulant or platelet inhibitors
to avoid bleeding and bruising.
The Restylane family of products is available only
through a licensed practitioner. Complete Instructions for Use for
Restylane, Restylane-L, Restylane Silk, and
Perlane are available at www.RestylaneUSA.com. Complete
Instructions for Use for Restylane® Lyft with
Lidocaine is available at www.RestylaneLyft.com
Sculptra® Aesthetic Important Safety Information
Indication: Sculptra® Aesthetic (injectable
poly-L-lactic acid) is indicated for use in people with healthy
immune systems as a single regimen for the correction of shallow to
deep nasolabial fold contour deficiencies and other facial wrinkles
in which deep dermal grid pattern (cross-hatch) injection technique
is appropriate.
Sculptra Aesthetic should not be used by people that are
allergic to any ingredient of the product or have a history of
keloid formation or hypertrophic scarring. Safety has not
been established in patients who are pregnant, lactating,
breastfeeding, or under 18 years of age.
Sculptra Aesthetic has unique injection requirements and
should only be used by a trained physician. Contour
deficiencies should not be overcorrected because they are expected
to gradually improve after treatment.
Sculptra Aesthetic should not be injected into the blood
vessels as it may cause vascular occlusion, infarction or embolic
phenomena. Use at the site of skin sores, cysts, pimples,
rashes, hives or infection should be postponed until healing is
complete. Sculptra Aesthetic should not be injected
into the red area (vermillion) of the lip or in the peri-orbital
area.
The most common side effects after initial treatment include
injection site swelling, tenderness, redness, pain, bruising,
bleeding, itching and lumps. Other side effects may include
small lumps under the skin that are sometimes noticeable when
pressing on the treated area. Larger lumps, some with delayed onset
with or without inflammation or skin discoloration, have also been
reported.
Sculptra Aesthetic is available only through a licensed
practitioner. Complete Instructions for Use are available at
www.SculptraAesthetic.com.
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SOURCE Galderma; ZELTIQ Aesthetics, Inc.