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.”
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/
Contact information
Press Contact
Merz Therapeutics, a business of Merz Pharmaceuticals GmbH
Global Communications
+49 69 1503 1265
Elisa.Antz@merz.de
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Ingenic Semiconductor Integrates Allegro DVT Encoding IP into Next-Generation Smart-Video System-On-Chip Solutions3.7.2020 12:46:00 CEST | Press release
Allegro DVT, the leading provider of video semiconductor IP solutions, today announced that Ingenic Semiconductor, one of the leading system-on-chip companies in China has integrated the AL-E150 high-performance video encoding IP into its latest generation of Smart Video products. The Smart Video product family from Ingenic Semiconductor features highly integrated Video Processor system-on-chip (SoC) solutions targeted at various video applications such as consumer and professional video surveillance and battery-operated cameras. One of Ingenic latest video processors, includes Allegro DVT’s AL-E150 H.264/HEVC/JPEG encoder to handle compression of multiple video channels at resolutions up to 5Mpixels. This chip is now shipping in mass-volume. Brad Liu, VP of Smart Video BU, Ingenic commented, “With the AL-E150,Allegro DVT is able to offer a multi-format and feature-rich encoder IP which perfectly meets our requirements and represents the best trade-off between silicon area, high-video
Imaweb-IDF Group Completes Its Acquisition of Serinfer3.7.2020 11:16:00 CEST | Press release
Imaweb/IDF Group (“The Group”), one of the largest developers of customer relationship management (“CRM”) solutions and dealership management systems (“DMS”) for the automotive industry in Europe, announced today that it has completed the acquisition of Serinfer Servicios Informáticos S.L. (“Serinfer”), the computer software segment of the Alvariño Group, a Spanish developer, distributor and supplier of DMS for automobile dealers. The Group is backed by Providence Strategic Growth (“PSG”), the growth equity affiliate of premier asset management firm Providence Equity Partners (“Providence”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200703005051/en/ Serinfer develops a range of sophisticated products to address the evolving needs of automobile dealers. Its flagship offering is SERAUTO, a complete DMS solution that works modularly and can also be integrated to the existing technology of any dealership or workshop. SERAUT
Taiwan’s COVID-19 response win applause, friendship from around the world3.7.2020 10:52:00 CEST | Press release
Once considered the most vulnerable to the COVID-19 outbreak because it’s so close to China, Taiwan has turned out to be a model for the world’s fight against the pandemic, thanks to quick decisions and early measures by its government, and to the high standard of the island nation’s public health system and its people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200703005042/en/ The management of Grand Hotel in Taipei asks its guests to help form Zero on the building’s facade to celebrate no new COVID-19 cases for the sixth day in a row on May 1, 2020. (Hsu Chao-chang, CNA) According to real-time data released on Worldometer (https://www.worldometers.info/coronavirus/), a website tracking global COVID-19 figures, as of June 30, Taiwan, with only 447 cases, ranked 155th among 215 countries in terms of the number of infections. Only three entities with fewer cases have a larger population than Taiwan’s, which currently sta
Northern Data announces new Block.one backed customer3.7.2020 08:27:00 CEST | Press release
Northern Data AG (XETRA: NB2, ISIN: DE000A0SMU87), one of the world's largest providers of high-performance computing (HPC) solutions, continues to enjoy a very successful 2020 with the signing of 180 MW of capacity with a new customer. Northern Data's most recent customer is a Bitcoin mining operation backed by Blockchain Powerhouse Block.one with an initial 180 MW volume and an upsize option to 300 MW, which the company signed today and which shall go live in early 2021. Brendan Blumer, CEO of Block.one, says: "Block.one's focus on leveraging EOSIO to bring increased scalability and transparency to the greater blockchain industry led us to Northern Data and their strategic market positioning and strong leadership. We're excited to be collaborating with them to introduce unprecedented Bitcoin mining solutions, powered by EOSIO." Aroosh Thillainathan, CEO of Northern Data AG adds, "We are pleased that Block.one is convinced of our services and that we have won the company as another bl
ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir), a First-in-Class Treatment for HIV in Adults With Few Treatment Options Available2.7.2020 22:39:00 CEST | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations. Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at risk of progressing to AIDS and
Vertex Files Registration Statement for Proposed Initial Public Offering2.7.2020 22:31:00 CEST | Press release
Vertex, Inc.,a leading provider of tax technology and services, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of its common stock. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Vertex intends to list its common stock on the NASDAQ Global Market under the ticker symbol “VERX.” Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers and as representatives of the underwriters for the proposed offering. BofA Securities, Citigroup and Jefferies are also acting as book-running managers and JMP Securities, Stifel, William Blair and CastleOak Securities, L.P. are acting as co-managers for the proposed offering. The proposed offering will be made only by means of a prospectus. When available, copies of the preliminary prospectus relating to these securities may be obtained