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
Grid Dynamics Earns MACH Alliance's 2026 Agent Ready Award for Production-Scale Agentic AI19.8.2026 22:05:00 CEST | Press release
Key Takeaways: Grid Dynamics is named to MACH Alliance's inaugural 2026 Agent Ready cohort. Grid Dynamics won the award for its agentic AI capabilities and for programs delivered at a global food and beverage company and a global payments company. Grid Dynamics delivered the qualifying work through its Grid Dynamics AI Native (GAIN) platforms and Forward Deployed Engineer delivery model. Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced it has earned MACH Alliance's 2026 Agent Ready Award, becoming one of 35 companies named in the program's inaugural cohort. Agent Ready is an advanced certification that builds upon MACH Certification, the MACH Alliance's baseline standard for open, composable, and connected technology. The honor recognizes certified members that have moved agentic AI from pilots and demos into production, at scale, with the guardrails enterprise deployment requires. Every award is in
Xsolla Announces Multi-Year Strategic Partnership With the Good Game Club Podcast to Amplify Positive Stories From the Global Games Industry19.8.2026 18:10:00 CEST | Press release
Collaboration Brings Co-Created Episodes, Live Recordings At gamescom And GDC, And Stories From Studios, With Episodes Recorded Across the Globe Xsolla, a global video game commerce company, today announced a multi-year strategic partnership with Good Game Club, the independent, global podcast dedicated to sharing positive stories from the gaming ecosystem. The partnership builds on a broader effort to support the developers, publishers, and creators shaping the future of the games industry in a positive way by supporting good stories from the human side of video game businesses. The partnership spans the global events calendar, with joint podcast recordings planned each year at gamescom in Cologne and the Game Developers Conference (GDC) in San Francisco. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819127662/en/ Graphic: Xsolla Xsolla and Good Game Club will collaborate on recurring editorial segments and deep-dive ep
KAGA FEI Expands Its Software-Embedded Bluetooth Low Energy Module Lineup with ES4L15MA1 and EC4L15MA119.8.2026 16:00:00 CEST | Press release
KAGA FEI Co., Ltd., a global provider of advanced short-range wireless modules, announced today the development of the ES4L15MA1 and EC4L15MA1 Bluetooth Low Energy modules with embedded software for wireless communication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260802953307/en/ ES4L15MA1 (left) and EC4L15MA1 (right) sample modules These products are versions of KAGA FEI’s ES4L15BA1 and EC4L15BA1 wireless modules with embedded software, which use Nordic Semiconductor’s nRF54L15. Because the modules include the functions required for Bluetooth Low Energy communication, device manufacturers can develop products in a shorter period without having to develop wireless communication software from scratch. The modules help reduce software development workloads, shorten product development cycles, and lower development costs for a wide range of IoT devices. The need for wireless connectivity in IoT applications is growing acr
Xsolla Introduces Integrated Backend and Global Payment Solutions for Games, With Founding Partner AccelByte19.8.2026 15:00:00 CEST | Press release
Game Developers Can Now Apply For Early Access To The Integrated Solution Ahead Of Launch Xsolla, a global video game commerce company, today introduced integrated backend solutions for game developers through a founding partnership with AccelByte, a fully managed extensible games backend platform, and opened a closed testing program for a combined solution that pairs AccelByte Gaming Services (AGS) with Xsolla's global payments and monetization tools. Select developers can now apply for early access and help shape the integration ahead of its broader launch. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819624666/en/ Graphic: Xsolla As studios scale live games across PC, mobile, console, and the web, managing player persistence, gaming backend, and global transactions adds cost and slows launches. Through the founding partnership with AccelByte, Xsolla brings AccelByte's backend services together with its own payments a
Corpay Cross-Border Named the Official FX Partner of European T20 Premier League19.8.2026 14:30:00 CEST | Press release
Providing access to currency risk management and cross-border payments solutions Corpay, Inc.*, (NYSE: CPAY) a global leader in corporate payments, is pleased to announce that Corpay’s Cross-Border business has entered into an agreement with the European T20 Premier League (“ETPL”), a new franchise-based tournament sanctioned by the International Cricket Council, created to establish Europe as a dynamic force in the global T20 landscape. Under the agreement, Corpay becomes EPTL’s exclusive and Official Foreign Exchange (FX) Partner, along with being an Official Partner. As the EPTL’s exclusive foreign exchange partner, Corpay Cross-Border will provide the league with comprehensive FX risk management solutions to help mitigate foreign exchange exposure arising from its day-to-day business activities. Corpay Cross-Border’s award-winning platform will also enable the EPTL to streamline global payments through a single point of access. “Corpay Cross-Border is thrilled to be named the exclu
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