The Science Behind XEOMIN

State-of-the-art proprietary manufacturing

Clostridium botulinum is a naturally occurring toxin. Manufacturers use a selected strain, bred biologically in optimal conditions, to produce therapeutic botulinum toxin products.3 Botulinum toxin type A has a combined (neurotoxin + accessory proteins) molecular weight of 900 kDa, of which 150 kDa is the neurotoxin.3

XEOMIN is made from a purified botunlinum toxin type A that is produced from fermentation of Hall strain Clostridium botulinum serotype A.1 The molecular weight of XEOMIN is 150 kDa because the proprietary manufacturing process of XEOMIN isolates the active toxin from accessory proteins and reduces the proteins. As a result, XEOMIN has been formulated to have high biologic activity with a low protein load.10

The clinical significance of a lack of accessory proteins, including any impact on safety or efficacy, has not been established. This information about the XEOMIN manufacturing process and the properties of incobotulinumtoxin A is not intended to imply superiority over other botulinumtoxinA products.

Purifying botulinum toxin type A into XEOMIN® (incobotulinumtoxinA)

WARNINGS AND PRECAUTIONS

  • The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.

XEOMIN® (incobotulinumtoxinA) mechanism of action

XEOMIN blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine. Impulse transmission is re-established by the formation of new nerve endings.1

References

  1. XEOMIN® [package insert]. Raleigh, NC: Merz North America, Inc; 2015.
  2. Frevert J. Pharmaceutical, biological, and clinical properties of botulinum neurotoxin type A products. Drug R D. 2015(1):1-9.
  3. Dressler D, Benecke R. Pharmacology of therapeutic botulinum toxin preparations. Disabil Rehabil. 2007;29(23):1761-1768.
  4. Bigalke H. Properties of pharmaceutical products of botulinum neurotoxins. In: Jankovic J, Albanese A, Atassi MZ, et al, eds. Botulinum Toxin: Therapeutic Clinical Practice & Science. Philadelphia: Saunders Elsevier; 2009.
  5. Wenzel R, Jones D, Borrego JA. Comparing two botulinum toxin type A formulations using manufacturers’ product summaries. J Clin Pharm Ther. 2007;32(4):387-402.
  6. Botox [package insert]. Irvine, CA: Allergan, Inc; 2014.
  7. Dysport [package insert]. Wrexham, UK: Ipsen Biopharm Ltd; 2014.
  8. Aoki KR. Preclinical update on BOTOX® (botulinum toxin type A)-purified neurotoxin complex relative to other botulinum neurotoxin preparations. Eur J Neurol. 1999;6(suppl S4):S3-S10.
  9. Thistle F. Greenhouse gas emissions and botulinum neurotoxin packaging. Hosp Pharm Eur. 2012:64.
  10. Dressler D. Botulinum toxin drugs: future developments. J Neural Transm. 2008;115(4):575-577.