Merz Pharmaceuticals GmbH, a leading neurotoxin company, and a 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, the 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 is 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 the 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.”