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
Netmore and Cibicom Enter Strategic Partnership for Denmark and Introduce Unified Roaming Across the Nordics15.9.2026 09:00:00 EEST | Press release
Netmore Group, the leading network operator for Massive IoT, today announced that Cibicom has selected Netmore’s Operator Platform-as-a-Service (PaaS) to operate, optimize, and scale its nationwide LoRaWAN® network for Internet of Things (IoT) deployments. Cibicom is the largest LoRaWAN network operator in Denmark and provides critical communication infrastructure for nationwide broadcast and LTE450 services as well as tier 3 data center solutions and B2B fiber connectivity. The partnership means that Cibicom will replace its existing LoRaWAN Network Server with Netmore’s ThingPark Platform and that the Parties will work strategically together to ensure Danish customers can benefit from comprehensive and reliable LoRaWAN connectivity across Denmark. By leveraging Netmore's carrier-grade platform, Cibicom gains enhanced network scalability, seamless roaming, and high-availability features, improving its delivery of reliable, cost-effective connectivity to customers in utilities, energy
PSG Equity Holds Final Close of Third European Fund at Over €4.4 Billion15.9.2026 09:00:00 EEST | Press release
PSG Equity (“PSG”), a leading growth equity firm that specializes in partnering with software and technology-enabled services companies to drive transformational growth, today announced the final close of PSG Europe III (“PSGE III” or the “fund”) at over €4.4 billion in total committed capital. The fund reached its hard cap, receiving strong support from new and returning investors. PSGE III surpasses its €2.6 billion predecessor fund, which held its final close in October 2023. The Europe-focused fund saw commitments from state pension funds, sovereign wealth funds, insurance companies, family offices and high net worth individuals. PSGE III will continue the firm’s strategy of partnering with ambitious European software and technology companies, helping them to scale up as they seek to become pan-European category leaders with global reach. The fund aims to support businesses that are harnessing AI to redefine enterprise software and the next generation of AI-native companies, with r
Adabas & Natural Appoints Hans Roth as Chief Executive Officer15.9.2026 09:00:00 EEST | Press release
Adabas & Natural (A&N) today announced the appointment of Hans Roth as Chief Executive Officer, effective November 1. The appointment marks a defining moment as A&N enters its next chapter positioned for sustained, accelerating growth. Following the carveout of webMethods, StreamSets, Alfabet, Cumulocity, TrendMiner, and ARIS from Software GmbH, A&N is now back to its original roots as the multi-decade leading mission-critical database and infrastructure software suite. Roth joins from Red Hat, where he most recently served as Senior Vice President and General Manager for Europe, Middle East, and Africa (EMEA) and previously led Red Hat’s EMEA services business. Before joining Red Hat, Roth served as Vice President of the service delivery unit at Hewlett-Packard Enterprise for central Europe. “I’m thrilled to help build on A&N’s decades-strong foundation of mission-critical reliability and to drive continued growth, serving a customer base that entrusts us with operating the systems on
TreviPay Partners with Dynatos to Add e-Invoicing Capabilities to its B2B Payments Infrastructure15.9.2026 08:00:00 EEST | Press release
TreviPay, a global B2B payments infrastructure partner, today announced a partnership with Dynatos to expand e-invoicing capabilities for TreviPay clients operating across Europe and other markets. Through the partnership, Dynatos Routty Cloud proposition will provide embedded e-invoicing technology and compliance support, helping TreviPay clients exchange invoices across different formats, networks and country requirements in Europe and other global markets. E-invoicing requirements continue to expand across Europe and other global markets, adding complexity for businesses managing invoices across more than 60 countries with mandates announced or already in place. At the same time, invoicing has become an increasingly important part of the B2B buyer experience. TreviPay research found 68% of B2B buyers are more likely to choose a supplier offering invoice terms, up from 51% in 2023. As businesses expand across markets, delivering the invoicing experience buyers expect also requires na
Meiji Group to Showcase Japanese-Quality CMO/CDMO Services and a Global Manufacturing Network at CPHI Milan 202615.9.2026 08:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (HQ: Chuo-ku, Tokyo; President and CEO: Toshiaki Nagasato) will debut as the Meiji Group’s Pharmaceutical Segment at CPHI Milan 2026, at Fiera Milano, Milan, Italy, October 6–8, 2026. At the exhibition, the Meiji Group’s Pharmaceuticals Segment will showcase 80 years of expertise in Japanese standard quality control, manufacturing, and supply network from Japan to Europe, India, and Southeast Asia. It will also highlight group-wide contract manufacturing, from development to supply, tailored to customer needs. Through the exhibition, Meiji Seika Pharma aims to raise global awareness of the Meiji Group’s Pharmaceutical Segment, its brands, capabilities, production capacity, and contract manufacturing services, and to forge new global partnerships to expand its CMO/CDMO business. “CPHI Milan 2026” Exhibition Overview Exhibition Name: CPHI Milan 2026 Dates: October 6 (Tue) – 8 (Thu), 2026 Venue: Fiera Milano (Milan, Italy) Exhibition Area: CMO Area Booth Numbe
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