MERZ FORMS FULLY FOCUSED GLOBAL MEDICAL AESTHETICS BUSINESS: MERZ AESTHETICS
• Merz Group reorganizes into three distinct customer-focused businesses
• Appoints Bob Rhatigan as global chief executive officer of Merz Aesthetics®
Merz, a global leader in the field of aesthetics and neurotoxins, today announced plans to reorganize into three independently operating businesses: medical aesthetics, therapeutics and consumer care. Under this structure, Merz Aesthetics will be the largest dedicated medical aesthetics business globally. The reorganization was announced as Merz reported the completion of another year of strong business performance across all regions, exceeding fiscal year 2018/19 revenue targets. Merz’s global revenue growth of 6.8 percent was driven in part by 17 percent year-over-year growth in the aesthetics business.
In this new structure, all functions and aspects of global Merz Aesthetics business will be solely focused on serving the needs of customers. Merz Aesthetics global management team will now be based in Raleigh, North Carolina, centering the business in the largest and one of the fastest growing aesthetics markets in the world. Merz will start operating in the new structure January 1, 2020.
As part of this reorganization, Bob Rhatigan has been appointed global chief executive officer of Merz Aesthetics, assuming responsibility for all aspects of the global aesthetics business. Rhatigan previously served as CEO of Merz Americas. He has driven both Xeomin® (incobotulinumtoxinA) and Ultherapy® to double-digit growth, making Xeomin the fastest growing neurotoxin in the U.S. medical aesthetics market, and more than doubled Merz’s flagship injectable filler, Radiesse, in Latin America.
“We are pleased to make this change from a position of strength as an organization and in support of our long-term sustainability strategy. This positions Merz Aesthetics as the world’s only global fully-focused, medical aesthetics business, committed first and foremost to customers,” said Philip Burchard, Chief Executive Officer of the Merz Group. “Bob’s focus on customers, vision to expand our R&D efforts and drive to position Merz as the leading global medical aesthetics business, have materially strengthened who we are as a company and I warmly welcome Bob to this new role.”
“I am honored to lead this exceptional organization of dedicated and talented people,” said Rhatigan, global CEO of Merz Aesthetics. “Through the creation of a specialized global medical aesthetics business, we will become even more relentlessly focused on meeting the needs of our customers worldwide and helping to facilitate their success.”
PLEASE SEE BELOW FOR IMPORTANT SAFETY INFORMATION about XEOMIN®, INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adult patients.
IMPORTANT SAFETY INFORMATION
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted. XEOMIN is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
Use in patients with an infection at the injection site could lead to severe local or disseminated infection. XEOMIN is contraindicated in the presence of infection at the proposed injection site(s).
WARNINGS AND PRECAUTIONS
• The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
• Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
• Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional 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 XEOMIN.
• Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken:
• avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes;
• corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
• XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and Creutzfeldt-Jakob disease (CJD). No cases of transmission of viral diseases or CJD have ever been reported for albumin.
Glabellar Lines: The most commonly observed adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN was Headache (5.4%).
Co-administration of XEOMIN and aminoglycoside antibiotics or other agents interfering with neuromuscular transmission, e.g., tubocurarine-type muscle relaxants, should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects. The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
USE IN PREGNANCY
There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.
To find a XEOMIN provider, visit https://www.xeominaesthetic.com/find-a-provider/.
IMPORTANT RADIESSE® SAFETY INFORMATION
RADIESSE Injectable Implant is FDA-approved for hand augmentation to correct volume loss in the dorsum of the hands.
RADIESSE is contraindicated for patients with severe allergies, known hypersensitivity to any of the components of RADIESSE® , and patients with bleeding disorders. Introduction of the product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction.
Common adverse events observed in the clinical study of RADIESSE® injected into the dorsum of the hand include bruising, redness, swelling, pain, itching, nodule or bumps/ lumps, difficulty performing activities, loss of sensation and other local side effects.
For complete RADIESSE safety information, including information on adverse events from post-market surveillance of RADIESSE, please refer to the Instructions for Use at Radiesse.com. To report a problem with RADIESSE, please call MyMerz Solutions at 1-844-469-6379. To find a RADIESSE provider, visit https://www.radiesse.com/find-a-provider/
IMPORTANT ULTHERAPY® SAFETY INFORMATION
Copyright © 2019 Merz North America, Inc. All rights reserved. MERZ, MERZ AESTHETICS. the MERZ logo and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. Ultherapy is a registered trademark of Ulthera, Inc. Radiesse is a registered trademark of Merz North America, Inc.
Merz North America