Tokyo, Japan — Teijin Pharma Limited, the core company of the Teijin Groups healthcare business, announced today that it starts exclusive sales of Xeomin (incobotulinumtoxinA) for intramuscular injection in 50, 100 or 200 units on December 4 for the treatment of upper limb spasticity. The drugs have been listed in the National Health Insurance (NHI) drug price list on November 18.

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 of wrist flexion was observed in the phase-III clinical trials in Japan.

Teijin Pharma signed an exclusive license and co-development agreement for Xeomin in Japan with Merz Pharma GmbH & Co. KGaA in 2017 and was granted approval by Japans Ministry of Health, Labor and Welfare (MHLW) to market it for the treatment of upper limb spasticity.

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.

Teijin Pharma already provides various pharmaceuticals including osteoporosis treatment and medical devices such as sonic accelerated fracture healing system that supports patients suffering from musculoskeletal diseases. The company has also developed motor functions rehabilitation products such as electric stimulation device and portable robotic arm that supports the rehabilitation of paralyzed upper limbs. 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.

About Xeomin

Brand name

Xeomin 50 units for intramuscular injection

Xeomin100 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 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

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