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
Rehlko Expands Power Plus™ Connected-Services Capabilities, Enhancing Value Across Installed Base11.8.2026 15:15:00 CEST | Press release
Rehlko Power Plus™Delivers 24/7 Remote Monitoring, Advanced Diagnostics, and Fleet-Wide Asset Visibility to Critical Power Systems Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced the expanded capabilities of Rehlko Power Plus™ industrial remote monitoring. The cloud-based platform is designed to help customers reduce downtime, improve backup power reliability, and proactively manage critical power assets through real-time monitoring, alerts, diagnostics, and reporting. Rehlko Power Plus represents a meaningful expansion of Rehlko’s aftermarket capabilities and reinforces the company's strategy to deepen customer engagement across the asset lifecycle while growing its higher-value aftermarket business. As backup power systems become increasingly critical to business continuity, organizations need more than periodic inspections and reactive maintenance. Rehlko Pow
Boomi Ranked #1 Overall Leader in the 2026 ISG Buyers Guide™ for Application Integration11.8.2026 15:00:00 CEST | Press release
Boomi earns top rankings across Product Experience, Capability, Platform, Customer Experience in 2026 ISG Buyers Guide™ for Application Integration Boomi, the data activation company for AI, today announced it has been ranked the #1 overall software provider in ISG Buyers Guides™ for Application Integration 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260811102868/en/ Boomi Ranked #1 Overall Leader in the 2026 ISG Buyers Guide™ for Application Integration In the report published by ISG Software Research, a division of ISG (Information Services Group), Boomi was placed within ISG's highest quadrant classification, Exemplary. ISG's report states that “Boomi was designated a Leader Overall and in every category,” a distinction no other provider assessed achieved. Capability, Platform and Customer Experience Leader The ISG Buyers Guide™ looks at how well software providers deliver for their customers, evaluating both the
ILiAD Biotechnologies Expands Board of Directors and Appoints Chief Business Officer11.8.2026 14:30:00 CEST | Press release
Suha Jhaveri, Bill Warren and Jim Wassil added to ILiAD Board of Directors; Antony Blanc appointed Chief Business OfficerAppointments deepen vaccine development expertise and enhance global commercial and strategic leadership ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the appointments of Jim Wassil, currently Chief Operating Officer at Vaxcyte; Suha Jhaveri, former Strategic Advisor at Cidara before its acquisition by Merck; and Bill Warren, former Global Head of Antigen Design at Sanofi Vaccines, as independent members of ILiAD’s Board of Directors. The Company also announced the appointment of Antony Blanc, former VP, Head of Global Marketing and Global Strategic Pricing at GSK Vaccines, as Chief Business Officer. “Our recently appointed colleagues bring an extraordinary depth of experience in vaccine development, global commercialization, and strate
TEC reduces pressure on support teams with proactive outage communications powered by Adtran and GOCare11.8.2026 14:15:00 CEST | Press release
News summary: Fiber broadband providers need faster, more transparent ways to manage outages and reduce support surges TEC is now using GOCare OutageIQ integrated with Adtran’s outage notification API and Mosaic One to automate subscriber messaging Open APIs turn network insight into actionable workflows, improving responsiveness and operational efficiency Adtran and GOCare today announced that Telephone Electronics Corporation (TEC) has improved outage responses and reduced inbound support tickets using GOCare’s OutageIQ solution integrated with Adtran’s outage notification API and Mosaic One. Serving communities across Mississippi, Alabama and Tennessee, TEC delivers fiber broadband services built on a foundation of community investment and reliable service. By combining proactive notifications with real-time network insights, the service provider can now inform customers as issues are detected while equipping support teams with immediate context. This transparency helps build subscr
Kinaxis-Sponsored Study Identifies Supply Chain AI Accountability Gap Amidst Rapid Adoption Expectations11.8.2026 14:07:00 CEST | Press release
Trust, measurable outcomes, and governance lag, even as 41% expect autonomous-at-scale operations within two years Kinaxis® (TSX:KXS), a global leader in supply chain orchestration, today announced the findings of new independent research from IDC. The IDC InfoBrief, sponsored by Kinaxis, “Making Supply Chain AI Accountable,” reveals a growing chasm between organizations’ aggressive ambitions for autonomous AI adoption and their readiness to hold these advanced systems - which we believe underscores the need for a disciplined approach to AI investment and deployment to prevent costly failures and deliver measurable business value. What This Means for Supply Chain Leaders The IDC InfoBrief, which surveyed more than 2,000 supply chain leaders across nine global markets, found that while AI adoption is nearly universal - only 2% of respondents report no AI-enabled capabilities, and just 12% consider themselves AI leaders. Over half (52%) cite trust in AI-driven decisions as a top barrier
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