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
Venionaire Capital Mandated to Structure KISAB’s Next Growth Round19.5.2026 12:41:00 CEST | Press release
Growth round to target growth private equity and strategic investors as KISAB advances its 8-inch BPD-free SiC wafer platform Venionaire Capital has been mandated by Kiselkarbid i Stockholm AB (“KISAB”) to structure and support the company’s next growth round. The mandate includes investor relations, investor communications and strategic financing preparation, targeting growth private equity and strategic investors. KISAB is a Sweden-based silicon carbide semiconductor materials company focused on advanced SiC substrates for power electronics. The company publicly highlights its 8-inch BPD-free n-type silicon carbide wafers, with the 8-inch platform representing an important technological step for next-generation high-performance power electronics. KISAB has previously attracted approximately EUR 24 million across several financing rounds. Publicly named investors include Fairpoint Capital, Industrifonden and Ingka GreenTech. Venionaire Capital will now support the company in sharpenin
motif Launches Clarity, a First-of-Its-Kind AI Financial Intelligence System19.5.2026 12:39:00 CEST | Press release
Clarity applies contextual understanding to market intelligence, enabling auditable, high-quality AI wealth advisory for financial institutions motif, the AI wealth advisory company backed by Liminal (a venture creation group founded by Temasek), today launched Clarity, an AI financial intelligence system that tracks how markets, assets and financial relationships connect, and how and why they change over time, building enriched connections that deliver the kind of structured, sourced insight that financial institutions have never had, even with dedicated analyst teams. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511241653/en/ motif Launches Clarity, a First-of-Its-Kind AI Financial Intelligence System Financial institutions integrate Clarity into their products so customers can make better-informed investment decisions, while analysts and product teams use it to track market shifts and plan accordingly. Informed inves
Axelspace Announces Launch of Seven GRUS-3 Earth Observation Microsatellites, No Earlier Than July 202619.5.2026 10:30:00 CEST | Press release
Enabling Wide-Area, High-Frequency Observation to Expand the Applications of Satellite Data Axelspace Corporation, a leading developer and operator of microsatellites dedicated to realizing its vision of “Space within Your Reach,” announced today that GRUS-3, a set of seven next-generation Earth observation microsatellites, is scheduled to be launched no earlier than July 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519449959/en/ Seven flight model of GRUS-3 next-generation Earth observation microsatellites ©Axelspace The seven GRUS-3 microsatellites will launch aboard the Transporter-17 rideshare mission via Exolaunch, a global leader in launch mission management, satellite integration, and deployment services, from Vandenberg Space Force Base in California, USA. We currently operate five optical Earth observation microsatellites, GRUS-1, under our Earth observation data service, AxelGlobe. With the launch of its
Money20/20 Europe Announces Powerhouse Speaker Lineup Featuring Leaders from Klarna, BBVA, ABN AMRO, Mastercard, eToro, and Revolut19.5.2026 10:10:00 CEST | Press release
Leading voices in payments, banking, and fintech innovation to take the stage in Amsterdam Money20/20, the world’s leading fintech show and the place where money does business, today announced a stellar line-up of speakers for Money20/20 Europe happening on June 2-4 at the RAI in Amsterdam. The show will feature 450+ speakers across six stages, exploring the forces redefining global finance through AI innovation, digital assets, and regulatory transformation. Newly confirmed speakers include some of the most influential voices shaping the future of payments, banking, and financial services: Sebastian Siemiatkowski, Co-Founder and CEO, Klarna. A pioneer in the buy now, pay later revolution, Siemiatkowski has transformed consumer payments and continues to drive innovation in embedded finance and AI-powered shopping experiences. Onur Genç, CEO, BBVA. Leading one of Europe's most digitally advanced banks, Genç is at the forefront of banking transformation, leveraging data, technology, and
Mythic Acquires Videantis, One of Europe’s Leading Digital Processor IP Companies, to Build the World’s Most Energy-Efficient AI Compute Platform19.5.2026 10:00:00 CEST | Press release
Silicon Valley and German engineering unite to create a new AI compute champion for Europe and the world Mythic, a pioneer in analog compute-in-memory and architect of the industry’s most energy-efficient AI acceleration technology, today announced it has acquired Videantis GmbH, one of Europe’s leading digital processor IP companies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260519255958/en/ The transaction unites Mythic’s breakthrough analog compute platform with Videantis’ highly differentiated, unified digital processor architecture and production-proven software stack — accelerating Mythic’s delivery of a new class of hybrid AI compute platform with a 100x energy efficiency advantage over conventional GPU-based systems. This deal builds on Mythic’s recently announced agreement with Honda to co-develop next-generation AI chips for future vehicles — a validation of Mythic’s game-changing architecture in one of the wo
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