FRANKFURT, Germany–(BUSINESS WIRE)–Merz Therapeutics, a leader in the field of neurotoxins and a business under the Merz Group, and Teijin Pharma Limited, the core company of Teijin Group’s healthcare business, jointly announced today that Teijin Pharmaceuticals has won Additional approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to use Xeomin® (incobotulinumtoxinA) in 50, 100 or 200 units of intramuscular injection for the treatment of lower limb spasms.
Lower limb spasm is a symptom of upper motor neuron syndrome, which is mainly manifested by increased muscle tone of the limbs and excessive excitement of the stretch reflex as a sequelae of stroke. The main symptoms are difficulty in walking normally and an increased risk of falls due to unstable trunk, complicated or obstructed activities in daily life. Conventional treatment for leg spasms includes physical rehabilitation and the use of oral muscle relaxants or neuromuscular blockers, such as botulinum toxin type A.
Stefan Brinkmann, CEO of Merz Therapeutics, said: “The extended approval marks an important milestone for Merz Therapeutics and is the result of our close cooperation with Teijin Pharmaceuticals. We hope that our partners will successfully introduce this important spasticity indication to Japanese doctors and patients.”
Dr. Stefan Albrecht, Senior Vice President of Global R&D, Merz Therapeutics: “This label expansion in Japan is another outstanding example of the benefits that Xeomin ® provides to many patients with post-stroke spasticity. Doctors can now choose to treat lower and upper extremity spasticity, or they can be flexible as needed Apply individual doses carefully. We are proud of this achievement, especially the excellent cooperation with our partner Teijin.”
Teijin Pharmaceutical President Ichiro Watanabe said: “Teijin Pharmaceutical provides a variety of drugs, including osteoporosis treatments and medical devices, such as the sound wave accelerated fracture healing system for patients with musculoskeletal diseases. In response to demographic changes and increased health awareness , We are launching effective new drugs and solutions, including the realization of a more sustainable society. Teijin Pharmaceuticals continues to contribute to improving the quality of life (QOL) of patients by providing new treatment options for diseases with unmet needs. ”
Xeomin® effectively treats peripheral cholinergic nerve endings by weakening the contraction of voluntary muscles, and relieves muscle tension by inhibiting the release of a neurotransmitter called acetylcholine. The highly purified neurotoxin is the only active ingredient in Xeomin®. It is made by removing complex proteins from the type A botulinum toxin produced by Clostridium botulinum using the purification technology developed by Merz Pharma GmbH & Co. KGaA. The lack of complex proteins allows Xeomin® to reduce the production of neutralizing antibodies that can reduce efficacy. Significant improvement in the plantar flexor modified ashworth scale (MAS) score was observed in a phase III clinical trial in Japan.
Xeomin® is distributed by Merz Pharmaceuticals GmbH in more than 70 countries and is used to treat patients with upper limb spasm, cervical dystonia, blepharospasm or excessive salivation. Teijin Pharmaceuticals signed an exclusive license and joint development agreement for Xeomin® in Japan with Merz in 2017, and began exclusive sales of Xeomin® in December 2020 after obtaining approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan. Based on Merz’s Phase III clinical trial in Japan, the newly obtained additional approvals have changed some of the approved approvals.
Generally, for adults, Xeomin® should be injected into multiple rigid muscles. *The maximum dose per administration is 400 units, but it should be appropriately reduced to the minimum dose according to the type and number of target tonic muscles. If the effect of the previous dose diminishes, repeat doses are allowed. The dosing interval should be 12 weeks or longer, but it may be shortened to 10 weeks depending on symptoms.
* Myotonic: gastrocnemius (medial head, lateral head), soleus, posterior tibialis, flexor digitorum longus, etc.
Merz Therapeutics is a business of Merz Pharmaceuticals GmbH dedicated to improving the lives of patients around the world. With its unremitting research, development and innovation culture, Merz Therapeutics strives to meet unmet patient needs and achieve better results. Merz Therapeutics seeks to meet the unique needs of people suffering from movement disorders, neurological diseases, liver diseases, and other health conditions that seriously affect the quality of life of patients. Merz Therapeutics is headquartered in Frankfurt, Germany, with representative offices in more than 90 countries, and a North American branch in Raleigh, North Carolina. Merz Pharmaceuticals GmbH is part of the Merz Group, a privately held family-owned company that has been committed to developing innovations that meet the needs of patients and customers for more than 110 years.
Teijin (Tokyo Stock Exchange code: 3401) is a technology-driven global group that provides advanced solutions in the field of environmental value; safety, security, and disaster reduction; as well as demographic changes and increased health awareness. Teijin was originally established in 1918 as the first rayon manufacturer in Japan, and has now developed into a unique enterprise covering three core business areas: high-performance materials including aramid, carbon fiber and composite materials, as well as resin and plastic processing, Film, polyester fiber and product processing; medical care, including medicines and home health equipment for bone/joint, respiratory system, and cardiovascular/metabolic diseases, nursing and pre-symptomatic care; and IT, including medical, corporate and B2B solutions for public systems, as well as packaged software and B2C online services for digital entertainment. As expressed in the brand statement “Human Chemistry, Human Solutions”, Teijin is deeply committed to its stakeholders and aims to become a company that supports the future society. The group is composed of more than 170 companies and has approximately 20,000 employees in 20 countries/regions around the world. In the fiscal year ending March 31, 2021, Teijin announced consolidated sales of 836.5 billion yen ($7.7 billion) and total assets of 1.036.4 billion yen ($9.5 billion).
Post time: Sep-10-2021