XEOMIN ® (incobotulinumtoxinA) Receives European Approval for the Treatment of Chronic Sialorrhea in Children
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 (Sialorrhea Pediatric Xeomin Investigation). 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
2Berweck 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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Merz Therapeutics, a business of Merz Pharmaceuticals GmbH
+49 69 1503 2129
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
CBRE GLOBAL INVESTORS LANSERER EUROPEAN RESIDENTIAL IMPACT FUND MED EUR 465 MILLIONER I KAPITALFORPLIKTELSER FRA FIRE INVESTORER22.9.2021 13:22:00 CEST | Pressemelding
Dette er markedskommunikasjon. Vennligst les Placement Memorandum-dokumentet for CBRE European Residential Impact Fund S.C.A. SICAV-SIF før du tar investeringsbeslutninger. Dnne pressemeldingen skal ikke oppfattes som tilbud eller oppfordring til kjøp overfor amerikanske investorer. Denne pressemeldingen utgjør ikke et tilbud om å selge eller en oppfordring til kjøp av andeler i CBRE European Residential Impact Fund S.C.A. SICAV-SIF eller noe annet produkt, og skal ikke brukes eller legges til grunn for investeringsbeslutninger av amerikanske investorer. Eventuelle tilbud eller oppfordringer til kjøp vil kun bli fremsatt gjennom et konfidensielt Placement Memorandum-dokument og en tilknyttet tegningsavtale, som kun vil bli gitt til kvalifiserte investorer. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20210922005526/no/ Paul Oremus, Fund Manager for CBRE European Residential Impact Fund (Photo: Business Wire) CBRE Globa
YASA Spin-Out Evolito to Electrify Aerospace Market With Ultra-High Performance, Low-Weight Electric Motors22.9.2021 13:15:00 CEST | Press release
Evolito, a new company developing and manufacturing electric motors and power electronics for aerospace applications, launched publicly today as a privately-owned business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005519/en/ A concept image showing an eVTOL (electric vertical take-off and landing) powered by Evolito's electric propulsion unit. (Photo: Business Wire) Evolito was spun out earlier this year by YASA (the world-leading pioneer of automotive axial-flux electric motors acquired by Mercedes-Benz in July 2021) to exclusively commercialise YASA’s next-generation electric motor technology and IP for the rapidly-growing aerospace market. The business’s axial-flux motor technology has been proven in volume series production in the automotive industry and has even greater advantages in the aerospace market. As such, Evolito is uniquely positioned to drive forward the commercialisation and adoption of electric
Credence MedSystems Secures $39.9 Million Financing to Enable Scaling of Innovative Drug Delivery and Connected Health Systems22.9.2021 13:03:00 CEST | Press release
Credence MedSystems, Inc. announced today that it has closed a funding round with gross proceeds of $39.9 million. Sources of funding include strategic investments from Novartis Pharma AG, Molex Ventures LLC as well as additional investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005044/en/ The investment will be directed towards scaling of production capacity for the Credence Companion® and Dual Chamber Reconstitution Systems as well as development of other members of the Company’s platform of innovative drug delivery systems, including its connected health portfolio. “The funding comes at a great time as we take the manufacturing of our Companion and Dual Chamber systems to the next level to meet pent-up demand in the market,” stated John Merhige, Credence’s Chief Commercial Officer. Jeff Tillack, Credence’s Chief Operating Officer, added, “Our immediate focus is on implementing the production capacity to supp
UPC Hydrogen Acquires Exclusive License in Asia Pacific Region from Proton22.9.2021 13:00:00 CEST | Press release
UPC Hydrogen Pte Ltd ("UPC Hydrogen") is pleased to announce that it has acquired the exclusive license to produce hydrogen from technology developed by Proton Technologies Inc. (“Proton”) for a selection of countries in the Asia Pacific region. UPC Hydrogen is an affiliate of Renewables Asia Pacific Holdings Pte Ltd ("UPC Renewables"), a private company with 8 GW of wind, solar and storage in development, under construction or in operation across the Asia Pacific region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005284/en/ UPC Hydrogen Acquires Exclusive License in Asia Pacific Region from Proton Technologies (Photo: Business Wire) The licenced countries include Indonesia, Vietnam, Australia, Malaysia, the Philippines, Mongolia and Myanmar. UPC Hydrogen believes that the Proton technology can produce hydrogen in these countries at a price of less than US$1.00/KG from new, plugged, abandoned or uneconomic oil well
i2c Outlines Key Growth Opportunities for UK and Europe22.9.2021 12:12:00 CEST | Press release
i2c Inc., a leading provider of digital payment and banking technology, today disclosed what it sees as key opportunities for growth in the UK and European markets, highlighting digital first, B2B commercial payments, cryptocurrency and credit as high-demand areas in which it is favorably positioned to compete. “In the past 18 months, we’ve seen increased opportunities as well as validation and acceptance of our offering in initiatives where these criteria and related use cases play heavily to customers’ requirements,” said Jonathan Vaux, general manager for UK and EU at i2c. He also noted that the driving forces appear to be a combination of continued bank digitization, a surge in payments and financial innovation in the commercial space, heightened competition among crypto players to achieve faster innovation cycles and market expansion, and broad interest in reconstructing credit as an embedded feature. According to the company, its platform features distinct characteristics that UK
TransferMate Global Payments Selects ComplyAdvantage For The Company’s Award-Winning AML And Risk Screening Solutions22.9.2021 10:57:00 CEST | Press release
Today ComplyAdvantage, a global data technology company transforming financial crime detection announced that TransferMate Global Payments, a leading global B2B-payments technology solution provider, has selected the reg tech innovator’s award-winning customer onboarding, transaction screening and monitoring solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005398/en/ Charles Delingpole, CEO of ComplyAdvantage (Photo: Business Wire) Headquartered out of Kilkenny, Ireland, TransferMate is a subsidiary of Clune Technology Group founded by Terry Clune and is a leading global B2B payments technology firm enabling companies to send and receive cross-border payments faster and easier. Now more than ever before, fast growing enterprises like TransferMate are implementing the best technologies and processes not only to reduce their risk profile as it relates to financial crimes but also to help accelerate service expan
Investable Universe Launches Provocative Polar Futures Media Series22.9.2021 10:15:00 CEST | Press release
The real assets news site Investable Universe announces the launch of Polar Futures, a media series that examines the eight-nation Arctic region’s growing geopolitical importance and its potential for attracting hundreds of billions of dollars in direct investment to develop the region and its bounty of natural resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005180/en/ Institutional investors, pension funds and other investors are eyeing the potential of developing infrastructure, shipping, logistics, telecommunications, mining, aquaculture and marine resources and of incubating technologies that aid the transition to renewable energy. Additionally, new trans-Arctic shipping lanes made more accessible by climate change will focus competing political and military interests on the polar zone. Nuanced insights from pivotal figures Against this fluid strategic backdrop, the weekly newsletter and podcast series, c