Tuesday, 28 June 2011 18:25

Allergan Receives FDA Approval for cell-based in vitro-assay for BOTOX Featured

Allergan Inc. (NYSE:AGN) got the approval for a fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic from the United States Food and Drug Administration (FDA).

BOTOX® is a prescription-only medical product that contains tiny amounts of highly purified botulinum toxin protein refined from the bacterium Clostridium botulinum. The newly approved assay will be implemented immediately in the United States. Allergan estimates that use of the new assay will reduce the use of animal-based assay testing for BOTOX® and BOTOX® Cosmetic by up to 95 percent or more over the next three years, as other regulatory agencies around the world approve this new assay.

BOTOX® is a unique and complex biological product with 21 different approved medical uses, for instance to treat the abnormal head position and neck pain that happens with cervical dystonia, muscle stiffness in adult patients with upper limb spasticity and treatment of headaches in adults with Chronic Migraine. But the same formulation is used for cosmetical purposes (severe glabellar lines).

Because of the amount of neurotoxin in BOTOX® is extremely small (less than one gram per year is required to supply the entire world), a suitable replacement potency assay to the LD50 assay must therefore be sensitive enough to measure the complex mode of action of extremely small amount of the neurotoxin used in BOTOX® in the cellular level.

The new assay is specifically applicable to Allergan's botulinum toxin type A product. By now, the mouse LD50 potency assay is required by the FDA, the Medicines and Healthcare products. In Germany in the last three years 28,000 mice were dying of respiratory and muscle paralysis for the test purpose.

More information: http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=587234