Teijin Receives Additional Approval in Japan for Merz’s Xeomin® Botulinum Toxin Type A
23.6.2021 11:00:00 EEST | 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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005073/en/
Contact information
Press Contact
Merz Therapeutics, a business of Merz Pharmaceuticals GmbH
Global Communications
+49 69 1503 2129
Agnes.tesch@merz.de
Press Contact
Corporate Communications
Teijin Limited
+81 3 3506 4055
pr@teijin.co.jp
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Johnson & Johnson Receives CE Marking for ACUVUE OASYS MAX Reusable Contact Lenses10.9.2026 14:45:00 EEST | Press release
Johnson & Johnson (NYSE: JNJ) today announced that it has received CE Marking for ACUVUE OASYS MAX 2-Week,*** a new reusable contact lens featuring proprietary MAX technologies designed to deliver superior comfort and visual clarity, even at day 14.*†i¥1 The lens will be rolled out in select European countries later this year with wider market rollout in 2027. Globally, 140 million people wear contact lenses, with one in two choosing a reusable lens,2 and comfort remains their leading priority.3 With the continued rise in everyday use of digital devices and exposure to blue-violet light, more demands are being placed on patients’ eyes, often leading to reduced visual clarity and symptoms of dryness.4,5,6,7 ACUVUE OASYS MAX 2-Week brings Johnson & Johnson’s advanced MAX contact lens technologies to reusable contact lens wearers, helping address their evolving vision, comfort, and digital lifestyle needs. “People who choose reusable contact lenses should not have to compromise on comfort
Virtual Installation The Kuutar Garden by Jakob Kudsk Steensen Opens in Oulu, Finland, in September10.9.2026 14:37:00 EEST | Press release
Deep underneath the city centre of Oulu, Danish artist Jakob Kudsk Steensen’s site-specific installation The Kuutar Garden comes to life on 18 September as part of the Oulu2026 European Capital of Culture programme, featuring musical collaborations with Danny L Harle and vocalist yeule. “The Kuutar Garden evokes a new ecological reality, unrooted from our physical boundaries, into a rhythmic and ghost-like world nurtured by a moonlight illuminated botanical garden. I hope audiences feel connected to the emergence of new worlds, and the caring of overlooked plant life,” says Steensen. The Kuutar Garden emerges from over four years of ecological fieldwork within the Botanical Garden of the University of Oulu, one of the world's northernmost botanic gardens, where Steensen bore witness to subarctic winters set against the artificial glow of greenhouse architecture. From this encounter, Steensen has conjured a virtual replica of that architecture, carrying audiences into an otherworldly re
New Circularity Data: Nine Out of Ten Returned Items Lose Value for Retailers10.9.2026 14:33:00 EEST | Press release
New research from ReBound Returns and Advanced Supply Chain (ASC) has revealed a gap between retailers’ circularity ambitions and the value they are recovering from returned products. The Circularity Index, based on research among 150 senior leaders at mid-to-large UK and European retailers, found that 86% have an established approach to circularity in returns, with practices including resale, refurbishment, repair and recycling regularly used across the business. For 27%, circularity is a core part of how returns are managed. However, translating those strategies into commercial value remains difficult. On average, 12% of returned items generate no value, while only 9% of retailers resell more than half of their returned products at full price. There is also a significant opportunity still to be captured. 82% of retailers believe that up to half of their returned stock could generate additional value through enhanced recommerce strategies, while 62% already make regular efforts to rec
One Biosciences Receives €3,3 Million Funding Under i-Démo 5 From France 2030 to Accelerate Development of First Single-Cell Diagnostic for Triple-Negative Breast Cancer, in Collaboration With Institut Curie10.9.2026 14:02:00 EEST | Press release
One Biosciences, a techbio company spun off from Institut Curie pioneering clinical-grade single-cell tumor profiling, and Institut Curie, the leading French center for the fight against cancer, today announced support from Bpifrance through the France 2030 i-Démo1 program for the CAST project (Cancer Single-cell Analysis for Therapy), securing €3,3 Million in funding. This milestone marks a major step forward in the development of single-cell tumor profiling technology for routine cancer care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910763012/en/ Triple-negative breast cancer (TNBC) represents approximately 15–20% of breast cancer cases. Patients face high relapse rates, rapid disease progression and limited treatment options, while clinicians still lack reliable biomarkers to predict which patients will respond to immunotherapy or chemotherapy combinations. Current diagnostic approaches average signals across mil
New WSJ Intelligence Survey Highlights the Human Skills Companies Must Protect as AI Enters the Workplace10.9.2026 14:00:00 EEST | Press release
Philip Morris International (PMI) (NYSE: PM) and WSJ Intelligence, the in-house thought leadership consultancy for The Wall Street Journal's commercial sales organization, today unveiled The Cognition Index Research Report, a comprehensive study exploring the evolving role of human cognition in an AI-driven workplace. Surveying more than 2,500 business professionals across the United States, United Kingdom, Italy, South Africa, and Brazil, the report reveals that while business professionals are increasingly optimistic about AI’s role in improving decision-making, they continue to see human judgment, ethics, critical thinking and empathy as essential capabilities that must be actively protected and developed as AI becomes embedded in workplace workflows. “Human cognition is a bit like a muscle: use it or lose it,” says Moira Gilchrist, Chief Global Communications Officer at Philip Morris International. “AI can help us work more efficiently, but we need to be careful not to outsource ou
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