MERZ-THERAPEUTICS
23.6.2021 10:02:09 CEST | Business Wire | Press release
Merz Therapeutics , a business of the Merz Group and a leader in the field of neurotoxins, and Teijin Pharma Limited , the core company of the Teijin Group ’s healthcare business, jointly announced today that Teijin Pharma has been granted additional approval by Japan’s Ministry of Health, Labor and Welfare (MHLW) to market Xeomin ® (incobotulinumtoxinA) for intramuscular injection in 50, 100 or 200 units for the treatment of lower limb spasticity.
Lower limb spasticity is a symptom of upper motor neuron syndrome, which is expressed mainly by increased muscle tone of limbs and the hyperexcitability of the stretch reflex as a sequela of stroke. The main symptoms are difficulty in normal walking and increased risk of falling due to trunk instability, complicating or impeding activities in daily life. Conventional treatment of lower limb spasticity includes physical rehabilitation and the use of oral muscle relaxants or neuromuscular blockers such as botulinum toxin type A.
Stefan Brinkmann, CEO Merz Therapeutics: “The extended approval marks an important milestone for Merz Therapeutics and is the result of our close and trustful partnership with Teijin Pharma in Japan. We wish our partner a successful introduction of this important spasticity indication to the Japanese doctors and patients.”
Dr. Stefan Albrecht, Senior Vice President Merz Therapeutics Global R&D: “This label extension in Japan is another outstanding example for the benefits Xeomin ® offers to many post-stroke spasticity patients. Physicians now have the choice to treat lower and upper limb spasticity, also in combination and with the flexibility to apply the individual dosage as needed. We are proud of this achievement and in particular of the excellent collaboration with our partner Teijin.”
Teijin Pharma President Ichiro Watanabe said: “Teijin Pharma provides various pharmaceuticals including for osteoporosis treatment and medical devices such as a sonic-accelerated fracture healing system for patients suffering from musculoskeletal diseases. In response to demographic change and increased health consciousness, we are launching effective new drugs and solutions, including to realize more sustainable societies. Teijin Pharma continues to contribute to enhancing the quality of life (QOL) of patients by providing new treatment options for diseases with high unmet needs.”
Xeomin ® is effective in treating peripheral cholinergic nerve endings by weakening the contraction of voluntary muscles, and it relieves muscle tone by inhibiting the release of a neurotransmitter called acetylcholine. The highly purified neurotoxin, the only active ingredient in Xeomin ® , is made by removing complexing proteins from botulinum toxin type A, which is produced by Clostridium botulinum, using purification technology developed by Merz Pharma GmbH & Co. KGaA. The lack of complexing proteins enables Xeomin ® to reduce the production of neutralizing antibodies capable of lowering efficacy. A significant improvement in the modified ashworth scale (MAS) score for the plantar flexors was observed in phase-III clinical trials in Japan.
Xeomin® is being distributed by Merz Pharmaceuticals GmbH in more than 70 countries to treat patients with upper limb spasticity, cervical dystonia, blepharospasm or hypersalivation. Teijin Pharma signed an exclusive license and co-development agreement for Xeomin ® in Japan with Merz in 2017, and launched exclusive sales of Xeomin® in December 2020 after receiving approval granted by Japan’s Ministry of Health, Labor and Welfare (MHLW). The newly received additional approval for partial changes in the obtained approval based on the phase-III clinical trials conducted by Merz in Japan.
About Xeomin®
Brand name |
Xeomin® 50 units for intramuscular injection Xeomin® 100 units for intramuscular injection Xeomin® 200 units for intramuscular injection |
Nonproprietary name |
incobotulinumtoxinA |
Dosage form |
Injection (vial) |
Indication |
Lower limb spasticity |
Dosage and administration |
(for the treatment of lower limb spasticity) In general, for adults, Xeomin® should be injected into multiple tonic muscles.* The maximum dose per administration is 400 units, however, the dose should be appropriately reduced to the minimum depending on the type and number of targeted tonic muscles. Repeated doses are permissible if the effect of a previous dose diminishes. The dosing interval should be 12 weeks or longer but may be shortened to 10 weeks depending on the symptoms.
*Tonic muscles: gastrocnemius (medial head, lateral head), soleus muscle, tibialis posterior muscle, flexor digitorum longus muscle, etc. |
Xeomin ® is the registered trademark of Merz Pharma GmbH & Co. KGaA.
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
About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the fields of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Originally established as Japan's first rayon manufacturer in 1918, Teijin has evolved into a unique enterprise encompassing three core business domains: high-performance materials including aramid, carbon fibers and composites, and also resin and plastic processing, films, polyester fibers and products converting; healthcare including pharmaceuticals and home healthcare equipment for bone/joint, respiratory and cardiovascular/metabolic diseases, nursing care and pre-symptomatic healthcare; and IT including B2B solutions for medical, corporate and public systems as well as packaged software and B2C online services for digital entertainment. Deeply committed to its stakeholders, as expressed in the brand statement “Human Chemistry, Human Solutions,” Teijin aims to be a company that supports the society of the future. The group comprises more than 170 companies and employs some 20,000 people across 20 countries worldwide. Teijin posted consolidated sales of JPY 836.5 billion (USD 7.7 billion) and total assets of JPY 1,036.4 billion (USD 9.5 billion) in the fiscal year that ended on March 31, 2021.
Please visit www.teijin.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005073/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
Carnegie Mellon University and Cleveland Clinic Develop AI System to Interpret Cardiac MRI Scans with Enhanced Accuracy21.5.2026 14:05:00 CEST | Press release
Trained on more than 13,000 patient studies, novel system significantly outperforms existing models by up to 35% A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s Cardiovascular Innovation Research Center, has developed an artificial intelligence (AI) system capable of interpreting some of the most complex heart scans in medicine, cardiac magnetic resonance imaging (MRI), without the need for manually labeled training data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521762286/en/ A team of researchers from Carnegie Mellon University, in collaboration with Cleveland Clinic’s Cardiovascular Innovation Research Center, has developed an artificial intelligence (AI) system capable of interpreting some of the most complex heart scans in medicine, cardiac magnetic resonance imaging (MRI), without the need for manually labeled training data. The novel system, called CMR-CLIP, is d
The Live Moment Effect: Genius Sports and MediaScience Study Finds Specific Moments in Live Sports Can Double Unaided Brand Recall21.5.2026 14:00:00 CEST | Press release
New research shows that brands aligned with emotionally heightened moments in live sports can improve ad effectiveness Genius Sports Limited (NYSE: GENI), a global leader in real-time sports data, today released new biometric research conducted with MediaScience showing that ads delivered immediately after emotionally heightened moments in live sports can double unaided brand recall. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521475265/en/ The Live Moment Effect report from Genius Sports and MediaScience. The study, The Live Moment Effect, finds that advertising effectiveness is significantly influenced by a viewer’s emotional state immediately before an ad is shown. In controlled biometric testing, ads shown after high-intensity sporting moments, such as near-scoring plays or crucial momentum shifts, delivered approximately double the unaided brand recall of baseline conditions. The Moment Before the Ad Matters The r
Merck Announces First Patient Dosed in Phase 3 Study for Investigational Antibody-Drug Conjugate in Colorectal Cancer21.5.2026 14:00:00 CEST | Press release
Precemtabart tocentecan (Precem-TcT) is investigated as a potential first-in-class anti-CEACAM5 ADC, for the treatment of metastatic CRC (mCRC) CEACAM5 is overexpressed in the majority of colorectal tumors (~90%), and requires no patient selection Significant unmet need remains for clinically meaningful innovation in colorectal cancer (CRC), the second leading cause of cancer death worldwide Not intended for Canada-, UK- or US-based media Merck, a leading science and technology company, today announced that the first patient has been dosed in the Phase 3 PROCEADE®-CRC-03 trial (NCT07549412). The study is evaluating precemtabart tocentecan (Precem‑TcT), a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer (mCRC). “Leveraging our novel payload‑linker technology, Precem‑TcT is the first CEACAM5‑targeted ADC in clinical studies with an exatecan payload, rationally designed for stability and enhanced cancer
Baszucki Group Funds Oxford University Clinical Trial of Ketogenic Therapy for Early Psychosis21.5.2026 13:00:00 CEST | Press release
Randomized controlled trial will evaluate both symptom progression and underlying biology Baszucki Group today announced a £1.17 million grant to support a randomized controlled trial at the University of Oxford assessing the feasibility, safety, and efficacy of a ketogenic diet for patients at clinical high risk of psychosis (CHR-P). Researchers will test this nutritional therapy's ability to improve patients' mental and physical health. This project builds on a growing body of research suggesting the potential of metabolic therapies in treating serious mental illness. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260521877110/en/ Baszucki Group Funds £1.17 Million for University of Oxford Trial of Ketogenic Therapy for Early Psychosis Psychotic disorders carry a massive personal burden and are associated with a lower life expectancy. Psychosis does not develop immediately, but typically emerges following a period of early
Unpack ’26 sommerrejsetrends: Flere vælger indenlandske rejser, når de tænker mere bevidst over deres rejsevalg21.5.2026 12:35:00 CEST | Pressemeddelelse
Rejsebranchens førende databrevne trendrapport lancerer sin første sommerudgave nogensinde – Unpack ’26 Summer: The Trends in Travel I dag har Hotels.com udgivet Unpack ’26 Summer: The Trends in Travel, den nyeste udgave af virksomhedens førende trendrapport i rejsebranchen, som viser, hvordan rejseadfærd former sommerens rejsevalg. Efterspørgslen på indenlandske rejser præger sommerens ferieplanlægning. Interessen på sociale medier for indenlandske ferier er globalt steget med 77% sammenlignet med sidste år, og 44% af danske rejsende planlægger en indenlandsk rejse denne sommer*. Fra store sportsbegivenheder og koncerter til rejser inspireret af film og tv bygger Unpack ’26 Summer på indsigter fra den årlige hovedrapport Unpack ’26: The Trends in Travel™ for at fremhæve, hvor rejsende tager hen denne sommer. HHver tendens bygger på førstehåndsdata fra Hotels.com® kombineret med indsigter fra rejsende og overvågning af sociale medier. “Denne sommer bliver der stadig rejst – men på nye
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