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
ClickHouse Expands Collaboration With Microsoft, Bringing Fabric Integration, Deeper OneLake Interoperability, and Enterprise Deployment Flexibility29.9.2026 09:30:00 CEST | Press release
ClickHouse, the company behind the open-source, real-time analytical database that has become the data layer for the AI era, today at The European Microsoft Fabric + SQL Community Conference announced a significant expansion of its strategic collaboration with Microsoft. The announcement encompasses four major milestones: the launch of the native ClickHouse workload for Microsoft Fabric, the general availability of OneLake read, the public preview of OneLake write, and the availability of ClickHouse Bring Your Own Cloud (BYOC) in the Microsoft Marketplace. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260929947201/en/ ClickHouse expands collaboration with Microsoft This expansion builds on ClickHouse's growing presence within the Microsoft ecosystem, where data-intensive organizations rely on ClickHouse Cloud on Azure to power real-time observability, business intelligence, AI/ML pipelines, and analytical applications at sc
Opengear Expands Reach Through Pan-European Distribution Agreement with Ingram Micro29.9.2026 09:01:00 CEST | Press release
Opengear’s network resilience solutions now available across 20 European markets Opengear, a Digi International company (NASDAQ: DGII) and global leader in out-of-band management solutions, has signed its first pan-European distribution agreement with Ingram Micro, one of the world’s largest technology distributors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260929668925/en/ Opengear Expands Reach Through Pan-European Distribution Agreement with Ingram Micro The agreement will give resellers in participating Ingram Micro countries access to Opengear’s portfolio, supported by Ingram Micro's regional infrastructure, logistics capabilities and partner network. This expands Opengear’s existing reach in the UK, Ireland, Spain, Germany, Italy, France, Belgium and Luxembourg, and brings its network resilience platform to resellers and end-users in additional European markets, such as Switzerland, Hungary, and Czech Republic. “T
Freemarket and Axiym launch LIQUI-DT™ – real-time business access to primary-market USD₮ from Tether29.9.2026 08:00:00 CEST | Press release
Freemarket and Axiym today launched a world-first service that gives businesses 24/7 real-time access to freshly minted, primary-market USD₮ issued by Tether. LIQUI-DTTM gives businesses compliant access to primary market stablecoins inside a fully regulated payment ecosystem via Freemarket’s global payment network. In audited trials, clients have minted or burned more than $300 million to date. Institutional users and high-volume traders will benefit from superior price certainty and direct liquidity giving them budgetary control. As the USD₮ is minted directly in the primary market, treasury and compliance teams have clear provenance for internal reporting 1. The LIQUI-DT service works because while no single party owns the whole stack, it is integrated into the Freemarket network. The combination of Freemarket’s compliant fiat rails and payment network, Axiym’s liquidity engine and on-chain settlement layer and Tether’s primary market issuance creates a regulated payments network wi
Estonia and Owkin Partner to Advance Sovereign AI in Biology29.9.2026 08:00:00 CEST | Press release
Estonia, led by the National Applied Research Center Metrosert, and Owkin today announced a collaboration to advance sovereign AI in biological and health research, working with Metrosert, Estonia’s state-owned applied research organisation. The collaboration will evaluate how K Pro, Owkin’s AI scientist platform, can help approved researchers work with complex Estonian health data inside secure national infrastructure, enabling reproducible analysis, and faster generation of scientific insight while preserving data sovereignty. The first phase will focus on selected Estonian health-data cohorts, with Owkin and Metrosert also exploring high-value research areas including oncology, where linked clinical, molecular, imaging and treatment-outcome data could support future biomedical research. Estonia has built one of the world’s most advanced digital public infrastructures and holds population-scale health and biomedical data assets. The partnership will explore how these foundations can
Jumio Completes Worldwide Rollout of selfie.DONE™, Bringing Privacy-Focused Reusable Identity to EMEA29.9.2026 07:00:00 CEST | Press release
Selfie-first onboarding eliminates unnecessary ID scans for trusted users, backed by the global Jumio Identity Graph, consent-based privacy and real-time compliance Jumio, the leading provider of AI-powered identity intelligence, today announced the expansion of its reusable identity solution, selfie.DONE, across Europe, the Middle East, and Africa. This launch marks the final phase of Jumio’s selfie.DONE rollout, following successful launches in Latin America, North America, and Asia-Pacific — making true reusable identity available worldwide wherever Jumio operates. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928989719/en/ In regulated EMEA markets, organizations face the dual challenge of eliminating onboarding friction while adhering to stringent privacy standards and regulatory frameworks, including GDPR, PSD2, AMLD, and other evolving regulatory compliance requirements. selfie.DONE addresses this challenge with a
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