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
SBC Medical Group Holdings Announces First Quarter 2026 Financial Results14.5.2026 12:30:00 CEST | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a Medical Services Organization providing management support across a wide range of healthcare fields, today announced its financial results for the three months ended March 31, 2026. First Quarter 2026 Highlights Total revenues were $43 million, representing a 9% year-over-year decrease. Net income attributable to SBC Medical Group Holdings Incorporated was $11 million, representing a 47% year-over-year decrease. Net income margin was 26% for the first quarter of 2026, representing a year-over-year decrease of 19 percentage points. Earnings per share, which is defined as net income attributable to the Company divided by the weighted average number of outstanding shares, was $0.11 for the three months ended March 31, 2026, representing a 48% year-over-year decrease. EBITDA1, which is calculated by adding depreciation and amortization expense to income from operations was $18 million, representing a
Compass Pathways to Participate in RBC Capital Markets Global Healthcare Conference on May 19-20, 202614.5.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will attend the RBC Capital Markets Global Healthcare Conference on May 19-20, 2026 and will participate in a fireside chat on May 19 at 10:00am ET. A live audio webcast of this event will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of
FPT Strengthens Bavarian Presence with New Munich Office, Accelerating AI Transformation14.5.2026 11:13:00 CEST | Press release
Global technology corporation FPT officially cut the ribbon on its latest office in Germany. This milestone reinforces the company's long-term commitment to delivering AI-driven services to its growing customer base across Germany and the wider European market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514689341/en/ The inauguration ceremony was attended by H.E. Mr Nguyen Dac Thanh, Ambassador of Vietnam to Germany, alongside representatives from the local government, FPT executives, and key partners. Situated in one of Europe’s most dynamic technological and manufacturing hubs, the Munich office strengthens FPT’s delivery capabilities and enables faster, more scalable engagement across the region. The move underscores the company’s strategic focus on investing in key innovation hubs to meet rising demand for AI transformation and accelerate time-to-value for clients. "Our expanded presence in Munich allows us to sta
Reply Launches Model Factory, the Production Line for Creating Industrial-Grade Generative AI Models14.5.2026 10:00:00 CEST | Press release
Reply [EXM, STAR: REY] announces Reply Model Factory, an industrial production line for buildingfrontier generative AI modelsgrounded in corporate knowledge and designed to power AI systems and agents aligned with each organisation’s operational context. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514524231/en/ Reply Model Factory is an industrial production line for building frontier generative AI models grounded in corporate knowledge and designed to power AI systems and agents aligned with each organisation’s operational context. AI models are often built to operate across a wide range of tasks, drawing largely on public data. Enterprises, however, rely on internal knowledge: technical standards, regulatory requirements, operating procedures, proprietary systems and domain expertise. Reply Model Factory addresses this gap by enabling organisations to train models that understand their own context and operate consist
Stitch Raises $25M Series A Led by Andreessen Horowitz14.5.2026 09:00:00 CEST | Press release
In a16z’s first investment in the GCC, the Riyadh-based fintech positions itself as the unified infrastructure layer for financial institutions worldwide Stitch, the operating system built for modern financial institutions, today announced it has raised $25 million in Series A funding led by Andreessen Horowitz (a16z). The investment marks a16z’s first in the GCC and brings Stitch’s total funding to $35 million. In addition to a16z, existing investors Arbor Ventures, COTU Ventures, Raed Ventures, and SVC also participated in the round. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514070694/en/ Mohamed Oueida - Founder & CEO, Stitch (Photo: AETOSWire) Despite spending over $1 trillion on digital transformation in the last three years, most financial institutions are still running on the same fragmented, legacy infrastructure that has defined the sector for decades. Globally, banks spend $700 billion a year on technology
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