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
Lyft App Launches in Europe30.9.2026 14:00:00 CEST | Press release
North American riders can use their Lyft app when traveling in Europe Key takeaways: North American Lyft riders can now use one app in the U.S., Canada, and Europe. No need to download anything new. New technology allows the Lyft app to integrate any third-party marketplace, laying the groundwork for future international growth. Lyft has transformed from an everyday rideshare company into a global, multi-mobility platform. Starting today, Lyft (NASDAQ: LYFT) riders can use their Lyft app in cities across Europe. Early access to the Lyft app rolls out in Barcelona and Hamburg first; throughout October, the Lyft app will become available for riders to use in some of Europe’s largest cities including London, Rome, Paris, Berlin, Athens, and Warsaw. By the end of October riders visiting Spain, Italy, Greece, Poland, England, Scotland, Ireland, Austria, France, and Germany will have one go-to app when they cross the Atlantic, building on the foundations from this past summer beta testing th
A Workplace Worth Toasting: Bacardi Continues its Rise on Forbes World’s Best Employers List30.9.2026 13:45:00 CEST | Press release
Bacardi Takes Top Spot Among Spirits Companies with Jump to #69 Bacardi Limited is proving that a workplace worth toasting keeps getting better. The family-owned business has once again been named to the Forbes World's Best Employers list, taking the top spot among spirits companies. Climbing 17 places since last year, in 2026 Bacardi comes in at #69 globally. The jump in ranking reflects a commitment to creating a workplace where employees feel valued, empowered, and inspired to grow while helping shape the future of the company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930327935/en/ Bacardi Limited Leads Spirits Companies Forbes World's Best Employers 2026 Ranking. “At Bacardi, great moments start with great people. That's why we listen carefully to what they're telling us, learn from that feedback, and keep evolving. We want people to feel clear on how they can grow, confident they can make their mark, and suppor
Forrester’s 2027 European Predictions: Despite A Strong Desire To Regain Its Digital Sovereignty, Europe Will Selectively Reset, Not Sever, Key Technology Relationships30.9.2026 13:33:00 CEST | Press release
New AI sovereignty and platform governance rules will signal strategic intent but deliver limited near-term impact According to Forrester’s (Nasdaq: FORR) 2027 European predictions, unveiled today at Forrester’s Technology & Innovation Forum EMEA, Europe will enter 2027 determined to recover its digital autonomy, but the gap between its ambition and control will widen. More than half of European companies embracing AI will reduce their dependence on US hyperscalers due to sovereignty concerns, moving their critical data and applications to European providers. A lack of end-to-end sovereign alternatives, however, will require consumers, companies, and policymakers to pursue selective digital autonomy, which consequently will reshape consumer behaviours, cloud choices, mobility, resilience, and trade strategy with China. Forrester’s Predictions reports offer forward-looking insights into trends to help executives and their teams anticipate change, reduce uncertainty, and make confident d
Vasion® Named a Leader in the 2026 IDC MarketScape for Worldwide Print Management Solutions as Enterprise Print Becomes AI Ready30.9.2026 13:30:00 CEST | Press release
Vasion, the intelligent print automation company, today announced it has been named a Leader in the IDC MarketScape for Worldwide Print Management Solutions 2026 Vendor Assessment (doc # US54124826, September 2026). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260930788016/en/ According to the IDC MarketScape, "Organizations in sectors such as education, healthcare, government, manufacturing, financial services, and retail should consider Vasion when seeking support for business process automation revolving around print, output, and agentic or rules-based workflows. Vasion customers may derive considerable value from the vendor's solutions in support of unifying their organizations' digital transformation efforts, particularly where a single portal with functionality extending beyond print management is sought, and especially where FedRAMP® High Authorization, a SOC 2 Type II report, or ISO 27001/42001 certification is req
Pantheon Expands Middle East Presence With New Abu Dhabi Office and Senior Regional Appointment30.9.2026 12:56:00 CEST | Press release
Abu Dhabi office, based in ADGM, continues Pantheon’s global expansion to serve growing client demand in key markets such as the Middle EastFiras Mallah joins as Managing Director and Head of Middle East to lead capital formation with sovereign wealth funds, family offices, and financial institutions across the region Pantheon, a leading global private markets firm with approximately $84bn in assets under management, today announced the expansion of its presence in the Middle East with the opening of its first office in ADGM, the international financial center based in Abu Dhabi, alongside the appointment of Firas Mallah as Managing Director and Head of Middle East. Demand for access to private equity, infrastructure, and private credit strategies continues to build among sophisticated investors across the Middle East, who recognize Pantheon for its 40-year track record of innovation and expertise across primaries, secondaries and co-investment opportunities. Secondaries – pioneered by
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