Oct. 12, 2017

Teijin Limited

Teijin Limited announced today that it has signed an exclusive license and co-development agreement with Merz Pharma GmbH & Co. KGaA regarding 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 United States. 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 Limited, the core company of the Teijin Group’s healthcare business, will be solely responsible for executing and funding regulatory and commercialization 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 synthesized 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 million1 patients with cerebrovascular disease receiving continuous treatment and it is the most common (about 20%) reason2 for nursing care. 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.

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

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 paralyzed 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 commercialization of Xeomin® (incobotulinumtoxinA), Teijin looks forward to providing comprehensive solutions from onset to prognosis leading to enhanced quality of life for stroke patients.

About the Teijin Group

Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has some 170 companies and around 19,000 employees spread out over 20 countries worldwide. It posted consolidated sales of JPY741.3 billion (USD 6.5 billion) and total assets of JPY 964.1 billion (USD 8.5 billion) in the fiscal year ending March 31, 2017. Please visit www.teijin.com

About Merz

With approximately 3,000 employees and 34 subsidiaries, Merz is a leading global provider in the fields of Aesthetics and Neurotoxins. Privately held for more than 100 years, the company is distinguished by its in-house research and development, solid financial strength and continuous growth. In addition to its unique portfolio of products for minimally invasive and non-invasive skin rejuvenation and tightening, Merz also develops neurotoxin therapy to treat neurologically induced movement disorders. OTC medicines, dietary supplements and skincare products round off the offerings from the company, which is headquartered in Frankfurt, Germany. In fiscal year 2015/16, the Merz Pharma Group generated revenue of EUR 1,092.9 million. More information is available at www.merz.com.

Merz Contact
Merz Pharma GmbH & Co. KGaA
Global Corporate Communications
Mariana Smith Bourland
Phone: +49 151 4249 1466
Email: mariana.smith@merz.com

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