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
LTM Has Issued an Offer to Acquire Randstad’s Technology and Consulting Services Business in Europe and Australia to Scale Domain-Driven Solutions and AI Services22.5.2026 07:09:00 CEST | Press release
The deal would be part of a 360° partnership with Randstad involving: Proposed acquisition of USD 500M+ (€469M) business, primarily across Aerospace & Defence, Automotive, Utilities and BFS Five-year IT services partnership to drive AI-enabled transformation for Randstad’s India Global Capability Center Strategic talent MSP to support LTM’s expanding global workforce LTM and Randstad announced that LTM has issued an offer to acquire Randstad’s Technology and Consulting Servicesbusiness in France, Germany, Belgium, Luxembourg and Australia, representing USD 500+ million (€469M) in annual revenue, to scale domain-driven solutions and AI services in the region. The proposed acquisition would expand LTM’s presence in key markets, primarily across Aerospace & Defence, Automotive, Utilities and BFS. It would enable local domain expertise and complementary regional capabilities in domain-driven digital engineering, cybersecurity and IoT, supported by onshore and nearshore delivery through cen
Polpharma Biologics and Tuteur Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases22.5.2026 07:00:00 CEST | Press release
Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, today announced the signing of a landmark licensing agreement with Argentina-based Tuteur. Under this strategic partnership, Tuteur will obtain exclusive rights to commercialize a biosimilar for autoimmune diseases across Latin America (LATAM), excluding Brazil. Polpharma Biologics will retain full responsibility for the development and manufacturing of the biosimilar. Tuteur will be responsible for commercialization, marketing, and distribution in the licensed territories. This collaboration reflects a shared commitment to expanding patient access to high-quality, affordable biological therapies across the region. “Partnering with Tuteur represents an important step in advancing our mission to broaden access to biosimilars globally,” said Anjan Selz, CEO of Polpharma Biologics. “With their strong regional expertise and commercial capabilities in LATAM, we are well
Global Stars Ahn Hyo-seop and Khalid Release New Cross-Market Single “Something Special” via FANDOM Today22.5.2026 06:00:00 CEST | Press release
Produced by Woo “RAINSTONE” Rhee and Grammy Award-Winning Producer Troy “R8DIO” JohnsonStream the Single HERE For approved imagery, please download HERE Today marks the official release of “Something Special,” the highly anticipated cross-market collaboration from international star Ahn Hyo-seop and multi-platinum recording artist Khalid, available now via FANDOM on all major streaming platforms. Stream the single HERE. Musicow will also release an official music video in June, highlighting the unique chemistry between Ahn Hyo-seop and Khalid while bringing the song’s cross-cultural collaboration to life on screen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522928365/en/ Ahn Hyo-seop, globally recognized for his breakout role as “Jinu,” the leader of demon boy band Saja Boys in Netflix’s animated phenomenon KPop Demon Hunters, joins forces with Grammy-nominated artist Khalid for a genre-blending release that bridges t
Lenovo Group: Q4 and Full Year Financial Results 2025/2622.5.2026 01:47:00 CEST | Press release
Lenovo delivers exceptional fourth quarter results – maintaining growth and concluding strongest year in the Group’s history Lenovo GroupLimited (HKSE: 992) (ADR: LNVGY), together with its subsidiaries (‘the Group’), today reported fourth quarter and full year results for fiscal year 2025/26, marking an exceptional Q4 and the strongest year in the Group’s history. During the quarter, overall Group revenue reached an all-time fourth quarter high of US$21.6 billion, up 27% year-on-year, marking the highest year-on-year growth rate in five years, with adjusted net income[1]doubling year-on-year to US$559 million. AI-related revenue[2] stood out as a leading growth engine, growing 84% year-on-year to account for 38% of total Group revenue in Q4. For the full year, the Group delivered record revenue of US$83.1 billion, with adjusted net income growing 42% year-on-year to US$2 billion. All business groups achieved solid double-digit year-on-year revenue growth, with a notable record full-yea
Andersen Global styrker sine globale mobilitetskompetencer med samarbejdspartneren Graebel22.5.2026 00:05:00 CEST | Pressemeddelelse
Andersen Global fortsætter med at styrke sin multidimensionelle platform gennem en samarbejdsaftale med Graebel, en global leder inden for medarbejdermobilitet og managed services med hovedkvarter i USA og globale aktiviteter på tværs af Nord- og Sydamerika, Europa og Asien. Graebel blev stiftet i 1950 og samarbejder med mange af verdens mest anerkendte organisationer om en mere simpel tilgang til mobilitet og talentstyring. Virksomheden hjælper organisationer med at støtte medarbejdere gennem hele ansættelsen – fra praktikophold og onboarding til national og international mobilitet samt karriereskift – gennem tjenester, der spænder over strategisk planlægning, hjælp til afrejse og på destinationen, assistance under udstationering, hjemsendelse og design af mobilitetsprogrammer. Gennem strategisk rådgivning og intelligent teknologi gør Graebel det muligt for organisationer at træffe mere informerede beslutninger og afstemme talentmobilitet med en bredere forretnings- og arbejdsstyrkest
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