Licence and co-development agreement signed to develop botulinum toxin in Japan

Teijin announced it has signed an exclusive licence and co-development agreement with Merz Pharma for Xeomin (incobotulinumtoxinA), the novel type A botulinum neurotoxin, covering all expected indications for ethical pharmaceutical use in Japan

Xeomin (incobotulinumtoxinA) has been approved since 2005 in Europe and launched in more than 50 countries worldwide, including the US. Today, Xeomin (incobotulinumtoxinA) is being prescribed in the EU and US to treat patients with upper limb spasticity, cervical dystonia and blepharospasm.

Merz is currently conducting phase 3 clinical trials with Xeomin (incobotulinumtoxinA) for upper and lower limb spasticity, as the first expected indications in Japan. Merz will be responsible for completing and funding these clinical trials already underway.

Teijin Pharma, the core company of the Teijin Group’s healthcare business, will be solely responsible for executing and funding regulatory and commercialisation activities for Xeomin (incobotulinumtoxinA) in any form of administration in all expected indications for therapeutic pharmaceutical use in Japan.

Botulinum toxin is administered by intramuscular injections and interferes with the release of acetylcholine at the neuromuscular junction, thereby causing a neuromuscular paralysis, which is manifested as persistent (but not permanent) muscle relaxation.

Xeomin (incobotulinumtoxinA) is a highly purified formulation of Botulinum toxin type A. The toxin is synthesised using a natural wild type strain of the bacterium Clostridium botulinum. The neurotoxin is produced as part of a high molecular weight complex.

During the manufacturing process of the drug substance incobotulinumtoxinA, the neurotoxin is purified from the complexing proteins. The active ingredient thus represents the pure botulinum neurotoxin type A, which is the essential protein for the pharmacological effects.

Xeomin (incobotulinumtoxinA) is expected to improve the activity of daily life, enhance the rehabilitation outcomes and reduce nursing care burdens by relieving the symptom of excessive muscle contraction. 

Hemiparesis is the most common post-stroke symptom and many patients also suffer spasticity, such as locking arms and fingers in a bent position and keeping legs in straight position due to excessive muscular tension. 

Japan has an estimated 1.2 million patients with cerebrovascular disease receiving continuous treatment and it is the most common (about 20%) reason for nursing care.1–2

Approximately 40% of these patients suffer from post stroke spasticity. Abnormal posture and limitation of joint movement lead to difficulties in their daily lives, impede rehabilitation, and increase burdens on caregivers, such as helping patients to dress and repositioning them in bed.

Teijin Pharma has contributed to improve the quality of life for patients with musculoskeletal diseases. The company is expanding its lineup of rehabilitation related  devices for hemiparesis with ReoGo-J, a robot for rehabilitating paralysed upper limbs and WalkAide, a neuromuscular electrical stimulation device for walking support.

The Teijin group is also developing allogeneic regenerative medical products such as SB623 for chronic strokes and JTR-161 for acute strokes. Through the development and commercialisation of Xeomin (incobotulinumtoxinA), Teijin looks forward to providing comprehensive solutions from onset to prognosis leading to enhanced quality of life for stroke patients.

References

  1. "Overview of Patient Survey 2014," Labor and Welfare, Ministry of Health
  2. “The 2017 White paper of aged society,” Cabinet Office
   

Companies