November 13th, 2019

// Xeomin Cosmetic® Licensed for Additional Indications In Canada

Xeomin Cosmetic® Licensed for Additional Indications In Canada

Expanded indications build on 10 years of proven efficacy and safety1

BURLINGTON, ON, Nov. 7, 2019  /CNW/ - Merz Pharma Canada Ltd., an affiliate of the global Merz Pharma Group, has announced that Health Canada has provided marketing authorization for additional indications for Xeomin Cosmetic® (botulinum toxin type A, free from complexing proteins), which include use in adults for the temporary improvement in the appearance of moderate to severe horizontal forehead lines and lateral canthal lines (crow's feet).2

The additional indications build upon the previous indication for the temporary improvement in the appearance of moderate-to-severe glabellar lines, also known as frown lines, between the eyebrows, in adult patients. 

The active ingredient in Xeomin Cosmetic® temporarily relaxes the muscle to give the treated area a smoother appearance.  It is the first and only neuromodulator free from unnecessary proteins for treatment of frown lines, crow's feet, and forehead lines.2 This 'clean effect' means there is less likelihood of reduced treatment response with ongoing use. 3,4

"Secondary treatment failure and reduced response is being recognized more frequently in aesthetic practice.5 As patients are using neurotoxins more regularly and in multiple facial areas, it's important to consider longer-term use and the need for a treatment  that does not contain impurities that are unnecessary and may impact future therapeutic effect," says Dr. Sam Hanna, MD, DABD, Medical Director at Dermatology On Bloor in Toronto, Ontario, Past President of the Toronto Dermatologic Society and a Diplomate of the American Board of Dermatology.

"Xeomin Cosmetic's expanded indications promote panfacial rejuvenation which is increasingly understood to be the standard of care in facial aesthetics. Treating panfacially promotes a more natural and robust aesthetic response which I believe results in better outcomes for patients," he continues.

Market research shows that the treatment of upper facial lines, such as frown lines, crow's feet, and forehead lines are the most requested of all facial indications, with demand growing. In its most recent report, the American Society for Aesthetic Plastic Surgery (ASAPS) noted treatment with botulinum toxin continues to grow exponentially, highlighting an increase of 35.8% in the procedure between 2014 and 2018.7

2019 marks 14 years of XEOMIN® availability globally and 10 years in Canada. Leading to its license and since, over 200 publications have supported XEOMIN®'s efficacy, the most notable demonstrating significant effect in the treatment of single indications and combined in the upper face; a favourable tolerability profile and maintenance of results over four months.1,3

Xeomin Cosmetic® requires no freezing or refrigeration so its packaging is simple and eco-friendly, meaning less waste in clinics, easy storage, and less environmental impact along the way as it's delivered to customers.

"We know that purity matters to physicians who inject with Xeomin Cosmetic® - and it matters to their patients.8 We're proud that Merz Canada can provide them with effective and innovative technology backed by science and precise manufacturing, in addition to a more environmentally-conscious option," says Bob Bennett, President and General Manager of Merz Pharma Canada.  

About Merz Pharma Canada 

Merz Pharma Canada Ltd. is a specialty healthcare company that develops and commercializes innovative, high-quality treatment solutions in aesthetics, skin care and neurosciences in Canada. Founded in 2009, Merz Pharma Canada Ltd. is located in Burlington, Ontario and is a wholly owned subsidiary of the Merz Pharma Group, a privately- owned company headquartered in Frankfurt, Germany. Our ambition is to become the most admired, trusted and innovative aesthetics and neurotoxin company. By developing products that improve patients' health and help them to live better, feel better and look better, we will continue to make significant contributions to the well-being of individuals around the world.

Safety Information

Xeomin Cosmetic® is indicated in adults for the temporary improvement in the appearance of moderate to severe horizontal forehead lines, lateral canthal lines and glabellar lines.  Xeomin Cosmetic is incobotulinumtoxinA (purified neurotoxin free from complexing proteins). Xeomin Cosmetic should only be given by a physician with the appropriate qualifications and experience in the treatment and the use of required equipment. Xeomin Cosmetic should not be used if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin Cosmetic; if an infection is present at the injection site; if you suffer from generalized disorders of muscle activity (e.g., myasthenia gravis, Eaton Lambert-Syndrome). Before you use Xeomin Cosmetic talk to your doctor or pharmacist if you suffer from any type of bleeding disorder; you receive substances that prevent the blood from clotting (anticoagulant therapy); you suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection; you suffer from a disease called amyotrophic lateral sclerosis (ALS); you suffer from any disease that disturbs the interaction between nerves and skeletal muscles (peripheral neuromuscular dysfunction); you have swallowing difficulties; if you had problems with injections of Botulinum toxin type A in the past; if you are due to have surgery. Tell your doctor if you are taking other medicines, especially aminoglycoside antibiotics which may increase the effect of Xeomin Cosmetic. If you are pregnant or breast-feeding, Xeomin Cosmetic should not be used. Side effects following treatment with Xeomin Cosmetic are rare and are generally not serious. The most commonly reported side effects include headache, swelling around the eye, changes in the shape of the eyebrow, drooping of the eyelid and pain and bruising near the injection site. Seek immediate medical attention if swallowing, speech or respiratory problems arise. XEOMIN and Xeomin Cosmetic contain the same active ingredient in the same formulation.  Therefore adverse events observed with the use of XEOMIN also have the potential to be associated with the use of Xeomin Cosmetic. 

This is not a complete list of side effects. For any unexpected effects while taking Xeomin Cosmetic, contact your treating healthcare provider.

Copyright© 2019 Merz Pharma Canada Ltd. All rights reserved.  XEOMIN® and Xeomin Cosmetic® are registered trademarks of Merz Pharma GmbH & Co. KGaA 

References:
1.Data on file.
2.Xeomin Cosmetic® Product Monograph, June 2019.
3.Kersher M, et al. Efficacy and safety of IncobotulinumtoxinA in the treatment of upper facial lines: results from a randomized, double- blind, placebo-controlled Phase III study. Dermatol. Surg 2015;41: 1149-1157. 
4.Kazerooni R, Decrease in Therapeutic Effect Among Botulinumtoxin Type A Agents: Analysis of the FDA Adverse Event Reporting System Database. AAD Presentation March, 2019.
5.Stengel G and Bee E. Antibody-induced secondary treatment failure in a patient treated with botulinumtoxin type A for glabellar frown lines. Clin Interv Aging 2011;6:281-284. 
6.Kantar Health Survey, 2015. 
7.The American Society for Plastic Surgery, National Data Bank Report, 2018.
8.GIM Company for Innovative Market Research. Boucouture Purity Insights; Results of a Quantitative Market Research in UK, Germany, Italy & Russia. September 2017. 

SOURCE Merz Pharma Canada Ltd.

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