MERZ-THERAPEUTICS
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
“And I Chose to Live” The Blind Sailor Mitsuhiro Iwamoto Takes the Stage at WEF23.1.2026 09:00:00 CET | Press release
- “HIRO’s CHOICE”: A Solo, Non-Stop Crossing of the Pacific Ocean- Mitsuhiro Iwamoto, a blind Japanese sailor based in San Diego, delivered a speech at the World Economic Forum Annual Meeting 2026 on January 21 (local time). He is undertaking the world’s first solo, non-stop trans-Pacific crossing by a blind person as part of the “Blind Sailor Single-Handed Pacific Crossing Project 2027.” WEF URL: https://www.weforum.org/ This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121469502/en/ Hiro Iwamoto / Global Keynote Speaker, First Totally Blind Sailor to Cross the Pacific In the spring of 2027, he will attempt a solo, non-stop trans-Pacific crossing, sailing a 28-foot yacht single-handedly from San Diego on the U.S. West Coast to Amakusa, Kumamoto Prefecture, Japan, without making any port calls. Project URL: https://hiros-choice.com/ The theme of his speech was “Sailing Through Barriers.” He spoke about how, since losing his
BitGo Holdings fejrer sin børsnotering på New York Stock Exchange23.1.2026 03:52:00 CET | Pressemeddelelse
BitGo Holdings, Inc. ("BitGo", "virksomheden", "vi"), en virksomhed inden for digital infrastruktur til aktiver, fejrer i dag sin lancering på New York Stock Exchange ("NYSE") som et børsnoteret selskab under tickersymbolet "BTGO". Medlemmer af BitGos ledelsesteam vil i dag kl. 09:30 ET ringe med åbningsklokken på NYSE. "I dag markerer et afgørende øjeblik for BitGo," udtaler Mike Belshe, administrerende direktør og medstifter af BitGo. "Vores indtræden på de offentlige markeder vil gøre det muligt for os yderligere at accelerere det finansielle systems overgang til en gennemsigtig og troværdig digital aktivøkonomi, samtidig med at vi fortsat kan levere enestående sikkerheds-, depot- og likviditetsløsninger til vores kunder. Vi er overbeviste om, at potentialet forude er stort, og at vi er unikt positioneret til at hjælpe institutioner med at gå fremtiden i møde." Belshe fortsætter: "Jeg er utroligt stolt af den virksomhed, vi har opbygget, og dybt taknemmelig for vores teams hårde arb
Tinaba with Banca Profilo Strengthens Its Global Positioning and Launches Digital Payments in the Chinese Mainland with Alipay+23.1.2026 02:41:00 CET | Press release
Through the “Pay Worldwide with Alipay+” feature available in the App, users can pay in the Chinese mainland at over 80 million merchants Tinaba with Banca Profilo announces the launch of digital payments in the Chinese mainland through the extension of its strategic partnership with Alipay+, Ant International’s global wallet gateway solution, bringing a simple, cashless and local payment experience to Italian travellers in the world’s largest digital market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260122062969/en/ Matteo Arpe, President of Tinaba with Banca Profilo, announces the expanded partnership with Alipay+ in Milan, Italy Starting today, users can pay in the Chinese mainland at over 80 million merchants simply by scanning a QR code directly from the Tinaba App. This innovation is particularly significant in a country where digital payments are the everyday standard and cash is increasingly less used. The servi
Andersen Consulting indgår samarbejde med Africa International Advisors22.1.2026 22:10:00 CET | Pressemeddelelse
Andersen Consulting udbygger sine kompetencer inden for strategi og forretningstransformation i Afrika gennem en samarbejdsaftale med Africa International Advisors (AIA), en Johannesburg-baseret virksomhed, der fokuserer på at forbedre virksomheders konkurrenceevne gennem sektorspecifik indsigt, innovation og rådgivning. AIA blev stiftet i 2002 og er et panafrikansk managementkonsulentfirma, der leverer strategibaserede rådgivningsydelser med fokus på digital transformation og ai-drevne forretningsresultater. Firmaet rådgiver kunder på tværs af sektorer, herunder energi og ressourcer, olie og gas, infrastruktur, handel og logistik, finansielle tjenesteydelser, bankvæsen og telekommunikation. AIA's strategiske perspektiv, lokale troværdighed og markedsadgang gør det muligt at udvikle og implementere løsninger, der samkører mennesker, processer og teknologi med henblik på at skabe meningsfuld forandring. "Vores mission har fra begyndelsen været at fremme udviklingen gennem en Afrika-cent
iQmetrix Announces First-Ever "Telecom Retail Summit" at MWC Barcelona 202622.1.2026 19:48:00 CET | Press release
Leading software provider challenges the industry on the growing disconnect between telecom innovation and the store experience. iQmetrix, the only global provider of Interconnected Commerce solutions for telecom retail, today announced its return to Mobile World Congress (MWC) Barcelona with the first-ever Telecom Retail Summit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260122446809/en/ As the industry converges for MWC Barcelona 2026, iQmetrix prepares to host the first-ever Telecom Retail Summit, transforming the conversation from network intelligence to the intelligent storefront. The exclusive half-day summit designed to spark an overdue conversation: telecom sells the most advanced technology on earth, yet delivers one of the least inspiring retail experiences in modern commerce. Bringing together telecom industry leaders, futurists, and retail innovators, the Telecom Retail Summit challenges the industry to rethi
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