Teijin Receives Marketing Approval for Merz’s Xeomin® Botulinum Toxin Type A in Japan
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.”
Xeomin® 50 units for intramuscular injection
Xeomin® 100 units for intramuscular injection
Xeomin® 200 units for intramuscular injection
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Merz Therapeutics, a business of Merz Pharmaceuticals GmbH
+49 69 1503 1265
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
Adagio Therapeutics Partners with Biocon Biologics to Bring Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets26.7.2021 23:05:00 EEST | Press release
Adagio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today announced a partnership agreement with Biocon Biologics Ltd., to combat the ongoing COVID-19 crisis in southern Asia. Biocon Biologics Ltd. is a fully integrated biosimilars company and a subsidiary of Biocon Ltd., a global biopharmaceuticals company, (BSE code: 532523, NSE: BIOCON). Under the terms of the agreement, Adagio will provide Biocon with materials and know-how to manufacture and commercialize an antibody treatment based on ADG20 in India and additional select emerging markets. ADG20, Adagio’s lead product candidate, is designed to be a potent, long-acting and broadly neutralizing antibody for both the treatment and prevention of COVID-19 as either a single or combination agent. Unlike other antibody-based therapies specifically targeting SARS-CoV-2, ADG20 has demons
SpeeDx Launch Solution for SARS-CoV-2 Variant Analysis26.7.2021 19:40:00 EEST | Press release
SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, have launched a new product line of research reagents to support reflex variant analysis for circulating SARS-CoV-2 variants of concern (VOC). The rapid development of Plex Prime® SARS-CoV-2 Genotyping* tests will support investigations and monitoring of the range of emerging and circulating SARS-CoV-2 VOC that have been linked to increased transmissibility, reduced vaccine efficacy, or other characteristics that may require specific public health actions.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005313/en/ SpeeDx unique technology excels in mutation detection applications and can readily be applied to variants reported in the SARS-CoV-2 sequence databases. Compatible with standard qPCR instrumentation, the PlexPrime® SARS-CoV-2 Genotyping research reagents can reduce the manual process of preparing positive samples for sequence analysis
V-Square Appoints Erik Norland as Head of Distribution26.7.2021 18:00:00 EEST | Press release
V-Square Quantitative Management (V-Square) has announced the hiring of Erik Norland as its Head of Distribution. A 20-year industry veteran with asset management, custody, and global markets expertise, Erik’s addition to the team bolsters our strong client-centric approach to deliver customized ESG solutions as we continue to build our reputation as a specialized global asset manager. He will lead the firm's sales, consultant relationship and client service functions across institutional, insurance and wholesale. Mr. Norland, based in Stockholm, will report to Mamadou-Abou Sarr, co-founder and President and will join the global leadership team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005571/en/ Erik Norland, Head of Distribution (Photo: Business Wire) "Erik is a results-focused leader who brings excellent experience in distribution strategy and execution, sales management and client relationship roles. I had th
Private and Public Sector Join Forces Under the Umbrella of the kENUP Foundation: BioNTech Announces Project to Develop the First mRNA-Based Prophylactic Malaria vaccine, and the set-up of Manufacturing Infrastructures in Africa26.7.2021 17:10:00 EEST | Press release
Today, BioNTech SE (“BioNTech”) announced the start of its Malaria project which aims at the development of a safe and highly effective malaria vaccine and the implementation of sustainable vaccine supply solutions on the African continent. The company’s project is part of a programme by the kENUP Foundation to accelerating the eradication of Malaria. This goal was out of reach so far, despite enormous financial and public health efforts of the global community. The scientific and entrepreneurial progress made during the COVID-19 pandemic raise hopes that a highly efficacious vaccine could soon help to eradicate Malaria. BioNTech aims to develop a safe and highly effective mRNA vaccine with durable protective immunity for prevention of malaria and disease associated mortality. To this end, BioNTech will assess multiple vaccine candidates featuring known Malaria targets such as the circumsporozoite protein (CSP), as well as new antigens discovered in the pre-clinical research phase. The
PPG to Expand Production Capacity for PPG ISENSE Gloss Beverage Can Coatings at Delaware, Ohio, Plant26.7.2021 16:02:00 EEST | Press release
PPG (NYSE:PPG) today announced that it is currently adding capacity for the production of overvarnish coatings for beverage can exteriors, including PPG ISENSE™ Gloss coatings, at its Delaware, Ohio, plant. PPG expects the addition of the Delaware plant’s new volume to existing overvarnish capacity at its Oak Creek, Wisconsin, packaging coatings facility will increase the company’s overall production of overvarnish coatings in the U.S. by 40%. “Beverage can manufacturers around the world are facing unprecedented demand for their products,” said Todd White, PPG general manager, U.S. and Canada, and global strategic accounts, packaging coatings. “With this added capacity, we are committed to helping them meet that demand while adding more security to their supply chain for beverage can coatings.” In addition to increasing supply chain security for its customers and the packaging industry, the Delaware plant will provide in-line analytical capabilities for enhanced batch consistency. “PPG
NET ZERO Leaders Summit (Japan Business Conference 2021) - Online Event From Wednesday, July 28 : Latest Information26.7.2021 16:00:00 EEST | Press release
Japan’s Ministry of Economy, Trade and Industry (METI) and the Japan External Trade Organization (JETRO) are pleased to announce the jointly organized “NET ZERO Leaders Summit (Japan Business Conference 2021)” to accelerate innovation in green investment and the realization of carbon neutrality. The event will take place from Wednesday, July 28, and will be held online. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210726005389/en/ Entrance_Lobby_Image (Graphic: Business Wire) Main Program In the main program, panel discussions will be held between 15 leaders of global companies and organizations. In addition, Mr. SASAKI Nobuhiko, Chairman and CEO of the Japan External Trade Organization (JETRO), will present the opening remarks, Mr. TOKURA Masakazu, Chairman of KEIDANREN (Japan Business Federation), will present the keynote speech and Prime Minister SUGA Yoshihide and Minister of Economy, Trade and Industry KAJIYAMA Hirosh
ADM Accelerates Growth of Leading Global Alternative Protein Platform with Planned Acquisition of Sojaprotein26.7.2021 15:05:00 EEST | Press release
Global nutrition leader ADM (NYSE: ADM) announced today that it has reached an agreement to acquire Sojaprotein, a leading European provider of non-GMO soy ingredients. Established in 1977, Serbia-based Sojaprotein has sales into 65 countries, offering a wide array of non-GMO vegetable protein ingredients for an extensive list of European and global customers in the meat alternative, confectionary, protein bar, pharmaceutical, pet food, and animal feed segments. The company had more than $100 million in sales in 2020. “Thirty years ago, ADM invented the soy vegetable burger, giving rise to the plant-based protein segment. Today, alternative proteins represents one of our core growth platforms, and as this $10 billion global industry grows to $30 billion over the next decade, we are investing to expand our unparalleled capabilities,” said Leticia Gonçalves, ADM’s president of Global Foods. “The addition of Sojaprotein – the largest producer of plant-based protein in southern Europe – ad
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