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
ASP Announces Strategic Partnership With ChemDAQ to Advance Safety, Confidence, and Compliance in Sterile Processing23.4.2026 01:42:00 CEST | Press release
Advanced Sterilization Products (ASP), a global leader in infection prevention and low‑temperature sterilization, today announced a strategic partnership with ChemDAQ, a leading provider of hazardous gas detection and monitoring solutions. Together, ASP and ChemDAQ will support healthcare organizations by strengthening safety practices, reinforcing regulatory confidence, and advancing best‑in‑class sterile processing environments. As part of this partnership, ASP and ChemDAQ collaborated on evidence rooted in industry engagement and thought leadership to help sterile processing professionals stay ahead of evolving standards and guidance, including AAMI ST58 and other recommendations related to sterilant exposure and workplace safety. These efforts underscore ASP’s commitment to continuous improvement and practical innovation that meets real‑world needs. This collaboration reflects ASP’s role as a trusted advisor to sterile processing professionals, bringing together proven low‑temperat
TSMC Debuts A13 Technology at 2026 North America Technology Symposium22.4.2026 21:00:00 CEST | Press release
Newest Node Pushes Density Scaling and Energy Efficiency to New Heights to Address Industry’s Most Demanding Applications TSMC (TWSE: 2330, NYSE: TSM) today debuted its latest innovation in its most advanced process technology at the Company’s 2026 North America Technology Symposium. TSMC’s new A13 process is a direct shrink of its industry-leading A14 node announced in 2025, enabling even more compact and efficient designs to address insatiable customer demand in computational requirements for next-generation artificial intelligence, high-performance computing (HPC), and mobile applications. Representing TSMC’s commitment to continuous improvement, A13 provides 6% area savings from A14. Design rules are fully backward compatible with A14, enabling customers to quickly migrate their designs to TSMC’s latest nanosheet transistor technology. In addition, A13 delivers increased power efficiency and performance gains through design-technology co-optimization, and is scheduled to enter prod
Galderma Shareholders Approve All Annual General Meeting Proposals22.4.2026 17:45:00 CEST | Press release
Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, announced that shareholders approved all proposals put forward by the Board of Directors at its Annual General Meeting (AGM), held earlier today via live webcast. This includes the payment of a gross dividend of 0.35 CHF per dividend-bearing share1, to be distributed out of reserves from capital contributions. Shareholders approved the election of Harry Kirsch as independent member of the Board of Directors, as well as the election of Samuel du Retail and Delphine Viguier-Hovasse, representatives of L’Oréal, as non-independent members of the Board. In addition, Thomas Ebeling (Chair), Daniel Browne, Maria Teresa Hilado, Karen Lee Ling, Roberto Marques, Sherilyn McCoy and Dr. Flemming Ørnskov were re-elected to the Board. The AGM also approved the company’s 2025 Annual Financial Statements, Non-Financial Report and Compensation Report. Detailed voting results and the official minutes will be published on Galderma's
Altrove and Bloomineral Named Winners of the 2026 Grand Prix ACF AutoTech22.4.2026 15:21:00 CEST | Press release
IoT.Bzh receives the inaugural Industrialization Prize at the 9th edition of the international automotive startup competition Altrove and Bloomineral have been crowned winners of the 2026 Grand Prix ACF AutoTech, the international startup competition recognizing the best of automotive innovation. The ninth edition was held on Wednesday, April 15 at the Automobile Club de France in Paris, where IoT.Bzh also received the first-ever Industrialization Prize. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422236542/en/ Picture of the end of the event with the winners : Bloomineral, Altrove and Iot.Bzh + all the Jury Members from French Automotive OEM and Tier1 Hosted by competition founder Richard de Cabrol and Simon Degiovanni, the evening gathered more than 250 leaders from the automotive, technology, digital, business and media sectors, with attendees joining both on-site and online. Six finalist startups, selected from mor
I/ONX Shatters the Host Tax: New Symphony SixtyFour Architecture Delivers 50% TCO Savings Across AI Inference and Fine-Tuning Lifecycle22.4.2026 15:00:00 CEST | Press release
Eliminating infrastructure overhead of legacy designs, I/ONX debuts a scaled AI inference and fine-tuning stack that cuts power by up to 30kW per rack and reduces cost of rack-scale deployments by up to 70% I/ONX High Performance Compute (HPC), a leading provider of heterogeneous AI systems, today announced the global launch of the Symphony SixtyFour, a high-density platform designed to collapse the physical and economic footprint of AI inference and fine-tuning infrastructure. By supporting up to 64 accelerators on a single node, I/ONX eliminates the redundant Host Tax—the massive overhead in power, hardware, and licensing that negatively impacts ROI in enterprise AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260422485327/en/ I/ONX Introduces Symphony SixtyFour: The Host Tax is Over. Save 30-50% on your AI Infrastructure Costs. While inference now accounts for 90% of enterprise AI workloads, enterprises are entirely li
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