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
Yamaha to Acquire Disguise, Expanding Its Capabilities in Integrated Audio, Video, Lighting and Media13.11.2026 09:00:00 EET | Press release
Yamaha Corporation today announced an agreement to acquire Disguise Technologies Limited (“Disguise”), a London-based provider of software and media server technologies for live and immersive experiences. Yamaha will acquire the company by purchasing all shares in its parent, Butterfly Topco Limited. The acquisition will expand Yamaha’s capabilities beyond audio into integrated audio, video, lighting and media solutions, in line with its strategy to expand beyond hardware into software and services. By combining Yamaha’s audio expertise and global reach with Disguise’s software, technologies and worldwide partner network, the companies will be better positioned to deliver immersive experiences across live entertainment, sports and other venues. Disguise’s technology powers live and immersive experiences worldwide, including tours by Beyoncé and Taylor Swift and venues such as New York’s Radio City Music Hall and Intuit Dome in California. “People are seeking richer and more immersive e
Mexico Becomes the First Market Worldwide to Receive Approval for Galderma’s Restylane ® Shaype™ for Both Chin and Its First Jawline Indication13.11.2026 08:00:00 EET | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that Restylane Shaype has been approved for temporary augmentation in the chin area and improvement of jawline definition in Mexico.1 This is the product’s first approval globally for the jawline, and further expands its availability for chin augmentation, where it is already approved across various markets globally including Europe, Brazil, Canada and Thailand. Restylane Shaype has been purposefully developed as a firmer gel to deliver a unique bone-mimicking effect and enable natural-looking structural enhancement without surgery.3-6 The lower face plays a pivotal role in overall facial balance, influencing proportions and profile,4 with recent market research conducted by Galderma finding that the chin is the third most treated area in existing HA injectable users.7 In the chin, genetic factors and age-related changes can lead to reduced definition and poor projection.4,8 In the jawline, factors such as
vVARDIS Announces Pricing of Initial Public Offering13.11.2026 07:02:00 EET | Press release
vVARDIS Holding AG (“vVARDIS”), a Swiss healthcare company operating in the dental med-tech sector, today announced the pricing of its initial public offering of 9,722,223 Class A ordinary shares at a public offering price of $18.00 per share. In connection with the offering, vVARDIS has granted the underwriters a 30-day option to purchase up to an additional 1,458,333 Class A ordinary shares at the initial public offering price to cover over-allotments. The Class A ordinary shares are expected to begin trading on the New York Stock Exchange on November 13, 2026 under the symbol “VVVV.” The closing of the offering is expected to occur on or about November 16, 2026 subject to the satisfaction of customary closing conditions. Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint bookrunning managers for the offering, with William Blair, UBS Investment Bank and Deutsche Bank Securities acting as bookrunners. A registration statement on Form F-1 relating to the offering has been file
Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4*13.11.2026 00:07:00 EET | Press release
The Empire State Building (ESB) is the gateway to Mount Olympus in Percy Jackson’s world, and now fans can experience the magic like never before. On Nov. 16, the Empire State Building Observation Deck (ESBOD) will unveil “Olympus Awaits,” a multi-level “Percy Jackson and the Olympians” takeover, in partnership with Disney+. The immersive takeover – included with every Observation Deck ticket – will feature an epic Throne Room, interactive photo opportunities, surprise giveaways, ESB x “Percy Jackson” merch, and more, available through Dec. 4, 2026.* This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112442266/en/ Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4* “This immersive NYC experience brings Percy Jackson’s adventures off the screen and into the ‘World’s Most Famous Building,’ where guests ca
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 19:09:00 EET | Press release
VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks to regulatory approval. To remove this barrier, Veristat uses its AI-enhanced platform to compress the timeline to submission-ready TLFs from weeks to days, with every output validated by stati
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