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
Dream Accelerates Growth of Asset Management Platform With Acquisition of Chancerygate, a Leading U.K.-Based Industrial Asset Manager and Developer31.7.2026 00:09:00 CEST | Press release
Combined platform is one of Europe’s leaders in urban industrial with over 80 professionals and 27 million square feet of GLA managed or under development across nine countries. Dream Unlimited Corp. (“Dream”) (TSX: DRM) today announced that Dream and Dream Industrial Real Estate Investment Trust (“Dream Industrial REIT”) (TSX: DIR.UN), have entered into definitive agreements for Dream to acquire Chancerygate Limited (“Chancerygate” or “CG”), a U.K.-based industrial developer and asset manager with a 30-year track record in the multi-let industrial (“MLI”) sector. Chancerygate currently manages a diversified portfolio of income producing and development assets totaling £1.2 billion ($2.2 billion). As part of the transaction, Dream will assume Chancerygate's investment management and development platform. Dream Industrial REIT will acquire Chancerygate's wholly owned real estate assets and co-investment interests across its managed ventures for consideration of approximately £78 million
Dream Industrial REIT Announces Entry Into U.K. Multi-Let Industrial Market and Growth of Strategic Private Ventures in Europe31.7.2026 00:06:00 CEST | Press release
This press release contains forward-looking information that is based upon assumptions and is subject to risks and uncertainties as indicated in the cautionary note contained within this press release. All dollar amounts are in Canadian dollars unless otherwise indicated. Dream Industrial Real Estate Investment Trust (TSX: DIR.UN) (the “Trust” or the “REIT” or “DIR”) today announced that the Trust and Dream Unlimited Corp. (TSX: DRM) (“Dream”), have entered into definitive agreements for Dream to acquire Chancerygate Limited (“Chancerygate” or “CG”), a U.K.-based industrial developer and asset manager with a 30-year track record in the multi-let industrial (“MLI”) sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730297448/en/ Audio Park, Sussex, UK - 104,000 sq ft As part of the transaction, Dream will assume Chancerygate's investment management and development platform. Dream Industrial REIT will acquire Chanceryga
Rimini Street Announces Fiscal Second Quarter 2026 Financial and Operating Results30.7.2026 22:03:00 CEST | Press release
Second Quarter Financial Highlights Include: Revenue of $111.1 million, up 6.7% year over year Adjusted Revenue of $108.0 million, up 10.0% year over year Remaining Performance Obligations (RPO) of $636.9 million, up 8.0% year over year Adjusted Annualized Recurring Revenue of $401.1 million, up 8.1% year over year Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced results for the fiscal second quarter ended June 30, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730702735/en/ Rimini Street Announces Fiscal Second Quarter 2026 Financial and Operating Results “Second-quarter results and four consecutive quarters of improved growth metrics demonstrate strong demand for our core Rimini Support™ offering, increasing adop
Rimini Street Launches Rimini Govern™ for AI to Deliver Comprehensive AI Agent Governance, Security & Interoperability as a Service30.7.2026 22:01:00 CEST | Press release
The new service enables organizations to quickly and easily implement and operationalize a global, enterprise-wide governance, control, security and performance measurement solution for AI agent activity and workflows Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced the immediate availability of Rimini Govern™ for AI, the newest offering in the company’s Rimini Govern portfolio of Governance, Risk and Compliance (GRC) solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730389723/en/ Rimini Street Launches Rimini Govern™ for AI to Deliver Comprehensive AI Agent Governance, Security & Interoperability as a Service The new managed service is delivered 24/7/365 through Rimini Street’s Global Command Centers by expert AI engineers to help organizations: Accelerate AI agent deployment Reduc
One Biosciences Announces Data Validating New Method for Single-Cell Transcriptomic Tumor Profiling from Clinical Pathology Samples30.7.2026 21:03:00 CEST | Press release
Sample-to-report workflow generating single-cell RNA expression profiles using routine FFPE pathology slides from four institutions validated across 88 specimens and six cancer types One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, today announced data establishing that single-cell RNA expression profiles can be generated from the standard, formalin-fixed paraffin-embedded (FFPE) pathology specimens obtained in routine cancer care using the company’s proprietary platform, OneMap™. The study, conducted with collaborators at Centre Léon Bérard, Hôpital Bichat–Claude Bernard, Institut Curie, and Memorial Sloan Kettering Cancer Center, was released as a preprint on BiorXiv. “Every tumor is a unique ecosystem of many different types of cells, some cancerous, some not. Single cell profiling enables us to understand what those cells are, what they’re doing and potentially how that may impact treatment outcomes,” said Helena Yu, MD, thoracic medical onc
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