MERZ-THERAPEUTICS
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
Stallergenes Greer Expands Venom Immunotherapy Production Capacity With Acquisition of Entomon s.r.l.7.1.2026 11:07:00 CET | Press release
Stallergenes Greer, a global leader in allergy therapeutics, today announced that it has entered into an agreement to acquire Entomon s.r.l., an Italian company specialising in the production of certified stinging-insect venom extracts, notably of the Hymenoptera order, used for the manufacture of diagnostic preparations and Venom Immunotherapy (VIT). The transaction is expected to close by the end of January. Entomon, currently recognised as the only company in Europe capable of extracting pure venom from Hymenoptera insects, produces pharmaceutical-grade insect venom using proprietary techniques (Entomon Capillary Extracted Venom®) for medical use. Through this acquisition, Stallergenes Greer bolsters its venom manufacturing capabilities and supply of raw materials for life-saving VIT treatments, whilst safeguarding patient care continuity. Hymenoptera venom allergy is the most common trigger of severe anaphylaxis in adults1. According to the EAACI guidelines on venom immunotherapy,
ARIS Announces New CEO to Lead Agentic AI-led Strategy7.1.2026 10:00:00 CET | Press release
CEO Appointment ARIS, a global leader in process intelligence and transformation software, today announced the appointment of Guillaume Bacuvier as Chief Executive Officer. Guillaume will lead ARIS through its next phase of growth as a fully standalone company, accelerating its evolution from a market leader in Process Intelligence into a foundational platform for enterprises deploying and governing Agentic AI. Guillaume brings deep international leadership experience across technology, data, and software-enabled businesses, with a proven track record of scaling global platforms and leading complex organisations. After starting as a strategic consultant at Booz Allen Hamilton, Guillaume spent over a decade at Google, rising to Vice President in EMEA where he built and scaled some of Google’s largest data-driven businesses in Europe and held P&L responsibility across multiple countries. In the last decade, Guillaume has served as CEO of multi-continent, data-centric companies including
I Squared Capital Acquires Ramudden Global, a Leader in Traffic Management and Infrastructure Safety7.1.2026 09:00:00 CET | Press release
Acquisition will accelerate Ramudden’s ambitious growth plan across North America and Europe supported by strong infrastructure spending tailwinds I Squared Capital, a leading global infrastructure investment manager, today announced that, through its flagship fund, it has agreed to acquire Ramudden Global, from funds advised by Triton Partners (“Triton”), a leading European mid-market sector-specialist investor. Ramudden Global is a leading international provider of traffic management and infrastructure safety services supporting the maintenance and upgrade of essential transport and utility networks. The company operates more than 190 depots across 13 countries in Europe and North America delivering mission-critical services that help to ensure safety, regulatory compliance and continuity of service across road, utility and broader infrastructure works. This investment underscores I Squared Capital’s commitment to investing in essential, regulated, infrastructure businesses that unde
RoslinCT and BOOST Pharma Announce Strategic Manufacturing Agreement to Advance Cell Therapy for Infants with Osteogenesis Imperfecta7.1.2026 09:00:00 CET | Press release
RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for the treatment of infants with Osteogenesis Imperfecta (OI), also known as brittle bone disease. Under the service agreement, BOOST Pharma has transferred its manufacturing process to RoslinCT’s state-of-the-art facilities in Edinburgh, Scotland. The partnership will progress toward GMP manufacturing of starting materials and clinical drug product, supporting Phase III clinical development of BT-101. The therapy is an allogeneic mesenchymal stem cell (MSC) product designed to address the underlying cause of OI at the earliest stages of life. BOOST Pharma was founded on pioneering science originating from Karolins
Daiichi Sankyo and GENESIS Pharma Enter Exclusive Agreement for VANFLYTA® Commercialization in Central and Eastern Europe7.1.2026 08:30:00 CET | Press release
Exclusive agreement covers 13 Central and Eastern European markets Collaboration will help expand access to VANFLYTA for patients with newly diagnosed FLT3-ITD positive AML Daiichi Sankyo (TSE: 4568) and GENESIS Pharma have entered into an exclusive license and supply agreement for the distribution and commercialization of VANFLYTA® (quizartinib) in 13 markets across Central and Eastern Europe for the treatment of adult patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML). Under the terms of the agreement, Daiichi Sankyo will be responsible for the manufacturing and supply of VANFLYTA while GENESIS Pharma will lead medical affairs, market access and commercialization efforts in Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Romania, Slovakia and Slovenia. Financial terms of the agreement are not being disclosed. VANFLYTA was approved in the EU in November 2023 for the treatment of adult patients with newly diagnose
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