MERZ-THERAPEUTICS
31.8.2021 13:06:13 CEST | Business Wire | Press release
Today, Merz Therapeutics, a business of the Merz Group and a leader in the field of neurotoxins, has been granted the use of XEOMIN® for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing ≥ 12 kg of chronic sialorrhea due to neurological / neurodevelopmental disorders on EU level.1 The national approvals of the country authorities involved will follow in the next weeks. The U.S. Food and Drug Administration granted approval in December 2020, and the Russian Federal Service for Surveillance in Healthcare in spring 2021.
Stefan Brinkmann, CEO Merz Therapeutics: “At Merz Therapeutics, we do everything to bring better outcomes to more patients. As XEOMIN® is already approved for the treatment of adult sialorrhea, we can now offer life-long treatment with our botulinum toxin A, staying a trusted partner for sialorrhea patients as well as their relatives and physicians for a lifetime.”
Dr. Marcus Gollub, President, Head of Region Europe complements: “Pediatric sialorrhea is a serious condition that can significantly impact not only the medical condition but also the quality of life of the children and their families. I am happy that with this new indication we are able to take care of the needs of those children suffering from drooling and contribute to a better life for them and their families.”
Sialorrhea, also known as drooling, is a symptom that occurs when excessive saliva accumulates in the mouth. It is a chronic impairment often seen in children with neurological disorders (e.g. cerebral palsy or traumatic brain injury) and/or intellectual disability or neurodegenerative diseases.
The approval by European authorities for the use of XEOMIN® for pediatric patients suffering from chronic sialorrhea, was achieved due to the convincing results of the SIPEXI study (Si alorrhea Pe diatric X eomin I nvestigation). It was a prospective, randomized, double-blind, placebo-controlled, multicenter phase III study with an extension phase evaluating the safety and efficacy of XEOMIN® in 255 children and adolescents aged 2 – 17 years up to 64 weeks. The study recently got published in Neurology, the premier peer-reviewed journal for clinical neurology research.2
XEOMIN® is being distributed by Merz Pharmaceuticals GmbH in more than 70 countries to treat patients with upper and lower limb spasticity, cervical dystonia, blepharospasm or hypersalivation. Merz uses state-of-the-art technology in its dedicated facility in Dessau, Germany, meeting the highest international standards for biologic manufacturing. The highly purified 150kDa neurotoxin is the only active ingredient in XEOMIN® . It is produced by removing complexing proteins from botulinum toxin type A, using XTRACT® purification technology developed by Merz Pharma GmbH & Co. KGaA.
XEOMIN® is the registered trademark of Merz Pharma GmbH & Co. KGaA.
1
European SmPC (Summary of product characteristics), 2021-08-31
2
Berweck et al. Neurology. 2021 Aug 2:10.1212/WNL.0000000000012573. doi: 10.1212/WNL.0000000000012573.
About Merz Therapeutics
Merz Therapeutics, a business of Merz Pharmaceuticals GmbH, is dedicated to improving the lives of patients around the world. With its relentless research, development, and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions, liver disease, and other health conditions that severely impact patients’ quality of life. Merz Therapeutics is headquartered in Frankfurt, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Pharmaceuticals GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 110 years to developing innovations that meet patient and customer needs.
Please visit www.merz.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210831005540/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
DCX Launches Comprehensive ECDU Portfolio – Enterprise-Class Coolant Distribution Units From 600 kW to 2.6 MW11.3.2026 16:34:00 CET | Press release
DCX Liquid Cooling Systems today unveiled its new ECDU (Enterprise Coolant Distribution Unit) platform, a family of three purpose-built CDU models that deliver real cooling capacities from 600 kW to 2.6 MW in industry-standard rack and in-row footprints. The portfolio has been engineered specifically for the accelerating transition to direct-to-chip liquid cooling in high-density enterprise, colocation, cloud, and hyperscale AI environments where thermal stability, uptime, and cost-efficiency are non-negotiable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311214891/en/ DCX ECDU, the new generation of Enterprise Coolant Distribution Units dedicated to HPC and AI deployments. The lineup consists of: Enterprise ECDU 1380/2600 V1 - Delivers 1.38–2.6 MW of actual cooling capacity (based on real-world secondary-loop conditions). Single-pump configuration reaches flow rates up to 3,333 liters per minute (lpm). Mission Critica
Andersen Global udvider sin afrikanske tilstedeværelse med tilføjelsen af Bravura11.3.2026 15:30:00 CET | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Afrika gennem en samarbejdsaftale med Bravura, en førende uafhængig skatte- og finansrådgivningsvirksomhed med base i Sydafrika og Namibia. Bravura blev stiftet i 1999 og leverer skattemæssig og finansiel rådgivning til børsnoterede og private virksomheder, iværksættere og kapitalstærke familier i hele regionen. Bravura kombinerer dyb finansiel ekspertise med en entreprenant tankegang med henblik på at levere skræddersyede, værdiskabende strategier. Virksomhedens tværfaglige team yder rådgivning inden for fusioner og opkøb, kapitalrejsning, omstrukturering af selskaber og successionsplanlægning. Derudover tilbyder firmaet løsninger inden for skatte- og regnskabsstrategi, international skattestrukturering, global mobilitet og overholdelse af valutakontrolregler. "Hos Bravura arbejder vi for at omdefinere standarder og levere skræddersyede, resultatorienterede løsninger, der skaber varig værdi for vores kunder," udtalte Ian Matthews, chef for
Laserfiche Earns 5-Star Rating in the 2026 CRN® Partner Program Guide11.3.2026 15:00:00 CET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — has been honored by CRN®, a brand of The Channel Company, with a 5-Star Award in the 2026 CRN Partner Program Guide. This annual guide is an essential resource for partners seeking vendor partner programs that match their business goals and deliver high partner value. As organizations navigate growing pressure to increase productivity and respond to regulatory change, Laserfiche’s AI-powered document management solutions enable users to transform operations and achieve meaningful business results at scale. Partners that innovate with Laserfiche solutions have the opportunity to grow profits through the Laserfiche Partner Program, which equips them with the tools and resources needed to deliver customer success. Laserfiche’s partner ecosystem drives sustainable growth, delivers differentiated solutions and maximizes opportunities for both partners and their customers. Laserfiche provides comprehensive AI and clou
I-Pulse Launches iTerra Pulsed Power Solution for Weed Control Without Chemicals11.3.2026 14:30:00 CET | Press release
iTerra is developing a non-chemical alternative to herbicidesiTerra combines high pulsed power and AI for weed control to support healthier crops I-Pulse Co-Founder, Chairman, and CEO Robert Friedland, I-Pulse Co-Founder and Chief Technology Officer, Laurent Frescaline, and iTerra CEO, Romain Leray, are pleased to announce the launch of iTerra, an agricultural technology subsidiary dedicated to non-chemical weed control within I-Pulse, the world leader in pulsed power technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311080724/en/ iTerra leverages I-Pulse’s proprietary high pulsed power technology to eliminate weeds at the root without harming crops, disrupting soil microbiology, or leaving chemical residues. Using AI-driven detection with accuracy rates of up to 95% in early trials, the system targets each weed individually with controlled, high-energy pulses lasting just five milliseconds. The treated weeds r
Canva Introduces Magic Layers, Turning Static AI Outputs Into Editable Designs11.3.2026 14:00:00 CET | Press release
Breakthrough in Canva Design Model now unlocks ability to transform flat content and images into layered and fully editable designs Canva, the world's leading all-in-one visual communication platform, today unveiled Magic Layers, a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311951174/en/ Magic Layers is a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. Generative AI has triggered a flood of visual content, but most of it remains locked in static image files. Even small changes can require starting over, with reprompts that can unintentionally alter the entire design. Powered by years of internal research and Canva’s growing investment in its AI development arm, Magic Layers ushers in a new era of editable
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom