Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leader in the field of neurotoxins, jointly announced that Teijin Pharma has received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for XEOMIN (incobotulinumtoxinA) for the treatment of chronic sialorrhea. XEOMIN has become the first-ever drug approved for this indication in Japan.

The approval by MHLW is based on Phase III clinical trials conducted by Merz Therapeutics in Germany and Poland and conducted by Teijin in Japan. XEOMIN is effective in suppressing saliva secretion by inhibiting the release of acetylcholine from cholinergic nerve endings and reducing the secretion of water and electrolytes from the salivary glands. A highly purified neurotoxin, the only active ingredient in XEOMIN, is made by removing complexing proteins from botulinum toxin type A, which is produced from Clostridium botulinum using purification technology developed by Merz Pharma GmbH & Co. KGaA.

Teijin Pharma President Masaki Taneda said, “Teijin Pharma has set a long-term vision of becoming a company that solves the challenges of patients, families and communities who need more support with rare and intractable diseases. We are pleased to offer this new treatment option to patients in Japan with chronic sialorrhea. Our continued collaboration with Merz Therapeutics has played a great role in achieving this milestone, which can expand the potential of XEOMIN for achieving positive patient outcomes.”

Stefan König, CEO of Merz Therapeutics said, “At Merz Therapeutics, we are committed to bringing better outcomes to patients with neurological diseases, and with strong partnerships like Teijin, we can maximize our efforts and reach. I am proud that Teijin has achieved this important milestone in providing the first treatment in Japan for people living with chronic sialorrhea. The ability to manage this distressing condition can improve the quality of life for many patients in Japan.”

Chronic sialorrhea can be caused by a variety of factors, especially underlying nervous system conditions including Parkinson's disease, atypical parkinsonism, stroke, brain injury, cerebral palsy, amyotrophic lateral sclerosis and muscular dystrophy. Patients with chronic sialorrhea refrain from going out due to the symptoms of drooling, and have difficulty speaking and eating, which interferes with their daily lives. It also places a heavy burden not only on patients but also on their families and caregivers to manage hygiene and health issues.

XEOMIN is approved in 81 countries worldwide for therapeutic and/or aesthetic indications, and in 51 countries for the treatment of chronic sialorrhea. Teijin Limited signed an exclusive license and co-development agreement in Japan for XEOMIN® with Merz in 2017, and launched exclusive sales of XEOMIN® in Japan in December 2020 after receiving manufacture and sale approval.