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
Owkin to License K Pro and Multimodal Data to Servier to Advance Oncology Research11.9.2026 14:00:00 CEST | Press release
Owkin, the agentic AI company pioneering the first automated AI scientist to revolutionize drug discovery and development, today announced an agreement with Servier, an independent international pharmaceutical group governed by a foundation, to license K Pro, Owkin’s AI Scientist, together with multimodal patient data to advance the company’s oncology research. Under the agreement, Owkin will make multimodal patient data from its MOSAIC network accessible for analysis to Servier’s research teams, within K Pro. This agreement is the next chapter in Owkin and Servier’s collaboration, their previous work together being in patient subgroup identification, also in oncology. K Pro is Owkin’s AI scientist. It brings multimodal patient data and specialized biological agentic AI to drive smarter and faster decision-making to each step of the pharmaceutical value chain. K Pro utilizes specialized biological tools, leveraging a decade of knowledge gained through pharmaceutical partnerships and st
Mohammed bin Rashid Al Maktoum Global Water Award Accepts Entries Until 30 September 202611.9.2026 10:09:00 CEST | Press release
The Mohammed bin Rashid Al Maktoum Global Water Award continues to attract strong interest from innovators, researchers and institutions worldwide as it enters the final phase of its fifth cycle. Overseen by the UAE Water Aid Foundation (Suqia UAE) under the umbrella of the Mohammed bin Rashid Al Maktoum Global Initiatives and with a total prize value of USD 1 million, the award promotes the development of sustainable solutions that help tackle water scarcity and improve access to safe water, particularly in communities most affected by water shortages. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260911305420/en/ HE Saeed Mohammed Al Tayer, Chairman of the Board of Trustees of Suqia UAE (Photo: AETOSWire) Applicants are encouraged to submit comprehensive information about their submissions, thereby helping the judging panel evaluate the various stages and mechanisms of their innovation, including water production, treatme
SES Launches New Content Orchestration and Hybrid Delivery Platform11.9.2026 07:30:00 CEST | Press release
SES CORE enables media customers to manage, monitor and orchestrate content delivery through a single interface, increasing visibility, flexibility and signal reliability SES today announced the launch of SES CORE, the first-of-its-kind content orchestration and hybrid delivery platform, designed to enable broadcasters and media customers to manage, monitor, and enable transmission of content seamlessly via satellite, fiber, and IP. Built on infrastructure-neutral architecture, SES CORE provides a single user interface for content delivery. By bringing multiple distribution technologies into a unified orchestration layer, the platform enables customers to select the most effective content delivery path, guaranteeing service reliability and consistent delivery of high-quality content to global partners. Through SES CORE, customers gain real-time visibility into service status by monitoring active content feeds. The platform provides network performance insights, automates operational ta
Ant International's Agentic Mobile Protocol Rolls Out Globally with Wallets and Acquirers; Initiating Collaboration on KYA Interoperability Framework with Mastercard and Visa11.9.2026 05:26:00 CEST | Press release
With payment leaders accelerating adoption, the Alipay+ ecosystem — with 50+ mobile payment partners, over 10 national QR schemes and serving over 2 billion consumer accounts — is evolving into the world's largest agentic payment network for mobile commerce.During Phase I in 2026, AMP partners up with 10 leading Alipay+ digital wallets that together serve 1.5 billion user accounts, as well as 7 leading acquiring partners including Adyen, Allinpay, Checkout.com, Fiserv, Global Payments, Nuvei, and Worldline.Ant International, Mastercard, and Visa have begun collaboration on a Know-Your-Agent (KYA) interoperability framework, designed to help card networks, digital wallet ecosystems, agent platforms and marketplaces streamline agent onboarding and identification across networks, based on shared principles while preserving each network's own verification and decisioning processes. As Ant International builds out its Agentic Mobile Protocol (AMP) with deeper interoperability and open-sourc
Peter Rauch Named President of Mountain Hardwear11.9.2026 01:00:00 CEST | Press release
Columbia Sportswear Company (Nasdaq: COLM), a leading innovator in active outdoor apparel, footwear, accessories and equipment, today announced that Peter Rauch will be the new President of the Mountain Hardwear brand. Mountain Hardwear's mission is to encourage and equip people to seek wilder paths. With over 30 years of wild wisdom, Mountain Hardwear continues to offer premium technical apparel, accessories and equipment products for climbers, mountaineers, skiers, snowboarders, and trail athletes. Troy Sicotte will transition to a new role as Global Vice President, Sales for Mountain Hardwear. Mr. Rauch transitions from his current role as General Manager of Columbia Brand North America and brings nearly 20 years of leadership experience across the Columbia family of brands, deep industry knowledge and a genuine passion for the outdoors. "Throughout his career, Peter has built strong cross-functional partnerships, developed high-performing teams, and delivered meaningful business re
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