Corporate

Validation of Alternative Test Method for Botulinum Neurotoxin

Frankfurt am Main,November 7, 2014

Merz, the pharmaceuticals company, has successfully completed validation of an in vitro assay for testing the potency and stability of its botulinum neurotoxin. The cell culture-based assay has been submitted to the Bundesinstitut für Arzneimittel und Medizinprodukte in Germany and the FDA…

Intensive research has enabled Merz to develop a cell culture-based alternative method for testing its botulinum neurotoxin. To become a substitute for the test method previously approved by the drug regulatory authorities, the alternative assay must achieve a level of precision comparable to that of the LD50 bioassay. Extensive testing during what is known as the validation process has ensured just such comparability.

By successfully completing validation, Merz has cleared the way to obtaining approval for a non-animal test. The company has submitted the assay to the regulatory authorities in the U.S. and Germany several months earlier than anticipated.

Merz is strongly committed to avoiding animal testing wherever drug safety and statutory or regulatory requirements permit it. Since its botulinum neurotoxin was approved in 2005, Merz has been working hard on a cell culture-based alternative to the LD50 animal test, and has been partnering for the past three years with Ipsen, a competing botulinum toxin provider.

With the validation of an alternative test method the company has taken a major step toward its goal of replacing the previous test method in a short time.

Merz’s botulinum neurotoxin is used in minimally invasive aesthetic medicine and treatments for neurologically induced movement disorders like torticollis, eyelid spasms, and spasticity of the upper extremities after a stroke.

About the Merz Pharma Group

Merz is a privately held pharmaceutical company based in Frankfurt, Germany. The company is active in research, development and distribution of innovative products in the areas of aesthetic medicine and dermatology as well as in the field of neurologically induced movement disorders. Merz Aesthetics offers a tailored and harmonized portfolio of products for minimally invasive treatments. With the fillers Radiesse®, Belotero®, Glytone® and the neurotoxin Bocouture®/Xeomin®, the company is an important player in the aesthetics market. For the treatment of neurologically induced movement disorders, Merz developed Xeomin®, the first botulinum neurotoxin that is free of complex proteins.
In the consumer products segment, Merz Consumer Care is the leading provider of OTC medication, dietary supplements and skincare products in the German-speaking countries with its well-known tetesept® and Merz Spezial® brands.

The Merz Pharma Group employs 2,738 people worldwide (prior year: 2,443). The Company generated revenue of EUR 994 million in fiscal year 2012/13 (prior year: EUR 980.2 million).