MERZ-PHARMACEUTICALS
29.6.2020 10:17:09 CEST | Business Wire | Press release
Merz Pharmaceuticals GmbH, a leading neurotoxin company and subsidiary of Merz Pharma GmbH & Co. KGaA, and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, jointly announced today that Teijin Pharma has been granted 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 upper limb spasticity.
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.
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 Pharma GmbH & Co. KGaA in 2017. In August 2019, Teijin Pharma applied for marketing approval based on a significant improvement in the modified ashworth scale (MAS) score of the wrist flexion, which was observed in a phase-III clinical trial conducted by Merz in Japan.
Upper limb spasticity is a symptom of upper motor neuron syndrome, which is expressed mainly by increased muscle tone of upper limbs and the hyperexcitability of the stretch reflex as a sequela of stroke. The main symptoms are motor paralysis, hyperflexion, appearance of pathological reflexes, and sensory disturbances that complicate or impede activities in daily living.
Conventional treatment of upper limb spasticity includes physical rehabilitation and the use of oral muscle relaxants or neuromuscular blockers such as botulinum toxin type A. Injections of botulinum toxin type A are a Grade A recommendation in the Japanese Guidelines for the Management of Stroke 2015.
"At Merz Therapeutics, we do everything to bring better outcomes to more patients. Therefore, we are very proud of our partnership with Teijin to make Xeomin ® available to physicians and patients in Japan,” said Stefan Brinkmann, CEO Merz Therapeutics. “We are confident that this treatment option can help patients with upper limb spasticity in Japan to experience more good days and achieve their unique goals.”
“Teijin Pharma already provides various pharmaceuticals and medical devices that help to contribute to improving quality of life of patients suffering from musculoskeletal diseases,” said Ichiro Watanabe, president of Teijin Pharma Limited. “We, responding to demographic change and increased health consciousness, are launching effective new drugs and providing other solutions to realize more sustainable societies. Teijin Pharma continues to contribute to improving the quality of life (QOL) of patients by providing new treatment options for diseases with high unmet needs.”
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 |
Upper limb spasticity |
Dosage and administration |
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 diminish. The dosing interval should be 12 weeks or longer, but may be shortened to 10 weeks depending on the symptoms.
*Tonic muscles: flexor carpi radialis, flexor carpi ulnaris, flexor digitorum dorsi, flexor digitorum brevis, radial biceps, biceps brachii, brachial musculature, pronation of the pronator, flexor progenitor, flexor pollicis longus, adductor pollicis longus, flexor pollicis brevis/opposite thumb 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 853.7 billion (USD 8.0 billion) and total assets of JPY 1,004.2 billion (USD 9.4 billion) in the fiscal year that ended on March 31, 2020.
Please visit www.teijin.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200629005235/en/
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
From AI to Autonomous Networks: Mobileum Spark Highlights the Next Frontier of Telecom Intelligence15.10.2026 09:00:00 CEST | Press release
Industry leaders get together to explore how trusted AI, Agentic Intelligence and automation are transforming risk management, accelerating autonomous network operations and unlocking new opportunities for value creation Mobileum Inc. ("Mobileum"), a leading global provider of telecom analytics and network solutions, brought together telecom operators and industry leaders during its Mobileum Spark events series in Lisbon (Portugal) and Frankfurt (Germany), to explore how Artificial Intelligence (AI), Agentic AI and automation are transforming network operations and accelerating the evolution toward autonomous networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015172815/en/ Telecom operators, industry leaders, and Mobileum experts at Mobileum Spark 2026. Focused on Risk Management & Fraud Prevention and Network Testing & Assurance, the events featured customer-led discussions, expert insights, and real-world use case
Merz Therapeutics Announces Completion of Recruitment in Two Phase III Trials Investigating XEOMIN® (incobotulinumtoxinA) for Migraine Prevention15.10.2026 08:00:00 CEST | Press release
Patient recruitment completed six months ahead of schedule in two global Phase III trials for migraine prevention MINT-E and MINT-C are evaluating XEOMIN® (incobotulinumtoxinA) for the preventive treatment of episodic and chronic migraine Trials recruited approximately 1,800 adults across 109 study sites in North America and Europe Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, today announced the completion of patient recruitment in two global Phase III clinical trials, MINT-E (NCT07018700) and MINT-C (NCT07018713), evaluating the efficacy and safety of XEOMIN® (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults. The trials recruited approximately 1800 adults across 109 study sites in North America and Europe. Migraine affects around 1.1 billion people worldwide, posing a significant burden on patients, society and healthcare systems.1 Both trials are evaluating the change in monthly migraine days from baseline to Month
Tourism Malaysia and Alipay+ Partner to Accelerate Malaysia’s Digital Tourism Transformation15.10.2026 07:10:00 CEST | Press release
Collaboration will connect seamless payments, in-app digital engagement and AI-powered travel services to enhance the visitor journey, empower businesses of all sizes and unlock wider cross-border commerce opportunities Tourism Malaysia and Alipay+, the unified wallet gateway of Ant International, today signed a Memorandum of Understanding (MoU) to accelerate cross-border commerce and digitalise merchant engagement across Malaysia's tourism economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261014035900/en/ (From left) Mr Mohd Akbal Setia (Head of VM2026 Secretariat and Senior Director, Advertising & Digital Tourism); Mr Mohd Amirul Rizal Abdul Rahim (Director General, Tourism Malaysia); Mr Danny Chung (General Manager of Alipay+ Global Growth Center and Vice President of Ant International); Mr Michael Guo, Alipay+ General Manager of SEA, South Asia and ANZ, Ant International) As Malaysia welcomes visitors for Visit Mal
PeDRA 2026: Nemolizumab Phase II Data Show Long-Term Symptom Relief for Children Aged 2 to 11 Years With Moderate-to-Severe Atopic Dermatitis15.10.2026 07:00:00 CEST | Press release
Patient-reported outcomes from a phase II study of nemolizumab in children aged 2 to 11 with moderate-to-severe atopic dermatitis show meaningful reductions in itch severity, better sleep and improved quality of life, maintained for a year1 Currently, there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis, despite the high unmet need – the disease can significantly reduce quality of life for children and create burden on their families2-8 These findings expand on the clinical evidence base for nemolizumab, which has multiple global approvals for adult and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis, and adults with prurigo nodularis9,10 Galderma (SIX: GALD), the pure-play dermatology category leader, today announced new phase II data showing that nemolizumab provided meaningful improvements in itch, sleep disturbance, and quality of life in children aged 2 to 11 years with moderate-to-severe
Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 115.10.2026 02:30:00 CEST | Press release
− ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) − Discovered by Takeda scientists in Japan, ORZEYFUL is the lead medicine in Takeda’s orexin franchise, with multiple programs for sleep-wake disorders and conditions where orexin biology plays a role − ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwide Takeda (TSE:4502/NYSE:TAK)announced today that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. ORZEYFUL is a first-in-class orexin receptor 2 (OX2R) agonist, in tablet form, designed to treat the underlying orexin deficiency associated with NT1. “We’re ex
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