XEOMIN^® (incobotulinumtoxinA) receives three new therapeutic indications in Australia

Frankfurt, Germany, November 22nd, 2023 – Merz Therapeutics, a business of the Merz Group and leader in the field of neurotoxins, has received approval from the Therapeutic Goods Administration (TGA) in Australia for the use of XEOMIN^® for the treatment of chronic sialorrhea in adults and children. This marks a significant milestone as XEOMIN^® is the first approved neurotoxin for the treatment of this condition in the australian market. Additionally, XEOMIN ^® is now approved for the treatment of pediatric spasticity of the upper and lower limb in children.

A new era in sialorrhea treatment

Sialorrhea, also known as drooling, is one of the most common chronic conditions that can occur as a result of neurological damage to the brain and is one of the most common chronic conditions in stroke survivors and children living with chronic neurological conditions like cerebral palsy. People living with sialorrhea cannot control their saliva and may produce excess amounts. The consequences range from quality-of-life issues, such as social isolation and unintelligible speech, to facial skin maceration and even increased morbidity due to choking, aspiration, dehydration and an increased risk of pneumonia.

Until recently, only oral medications were approved for the treatment of sialorrhea, and these were associated with a number of systemic side effects. “We are proud to contribute to the improvement of treatment options available to people living with sialorrhea. With the new approvals we can address a dire medical need and deliver better outcomes for more patients,” explains Stefan König, Chief Executive Officer Merz Therapeutics. “Moving forward, we will focus on spreading awareness of the new treatment option among healthcare professionals, train them in the proper injection of XEOMIN^® and thus empower them to include it in their practice”. Andrea von der Lippe, Head of Region International Markets, adds: “We are excited to extend our portfolio of treatment options in Australia and hope to build on this success in other markets in the APAC region.”

Enabling comprehensive treatment for children living with spasticity

“A full-label approval for both lower and upper limb spasticity is a fantastic achievement in itself and we are especially proud that this was based on our own clinical study data with XEOMIN^®,” says Stefan Albrecht, Chief Scientific and Medical Officer. “This will enable healthcare professionals to treat children living with multiple patterns of spasticity more comprehensively.”

Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes (‘muscle tone’) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex.¹ Spasticity is a chronic condition being a part of so-called upper motor neuron (UMN) syndrome, which is also characterized by muscle spasms, increased deep tendon reflexes, as well as loss of muscle strength, dexterity and endurance. In children and adolescents, the most common cause of UMN syndrome is cerebral palsy (CP), whose incidence in developed countries is 0.20-0.35% neonates. Approximately 80-90% of CP patients suffer from spasticity. Children and adolescents living with spasticity require treatment and rehabilitation throughout their lives. The degree of disability may however differ among individuals, depending on symptoms intensity, number of involved body parts, and concomitant disorders.

About XEOMIN^®

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. XEOMIN^® is free from complexing proteins and has a low risk of neutralising antibody formation. XEOMIN^® is being distributed by Merz Therapeutics in more than 70 countries to treat patients with upper limb spasticity, cervical dystonia, blepharospasm or chronic sialorrhea.

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to improving the lives of patients around the world. With its relentless research, development, and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions, liver disease, and other health conditions that severely impact patients’ quality of life.

Merz Therapeutics is headquartered in Frankfurt am Main, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 115 years to developing innovations that serve unmet patient and customer needs.

Please visit https://merztherapeutics.com/

About Merz

Merz Group is a global, diversified company with its headquarters in Frankfurt, Germany. Its commitment to innovation, long-term perspective, and focus on profitable growth depict the privately owned company that has been founded 115 years ago. Merz Group focusses on the businesses Merz Aesthetics, Merz Therapeutics, Merz Lifecare, Merz Real Estate and Merz Financial Investments. The company employs 4.337 people in 28 countries worldwide.
To learn more, please visit www.merz.com.

References

¹Lance, J.W. (1980) Pathophysiology of Spasticity and Clinical Experience with Baclofen. In: Lance, J.W., Feldman, R.G., Young, R.R. and Koella, W.P., Eds., Spasticity: Disordered Motor Control, Year Book, Chicago, 185-204.