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.
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.
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.
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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.
- 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.
- 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.
- 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.
- 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.
SOURCE Galderma; ZELTIQ Aesthetics, Inc.