Allergan Inc. (AGN), said Friday that the U.S. Food and Drug Administration has approved a fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX (onabotulinumtoxinA) and BOTOX Cosmetic. The company said the newly approved assay will be implemented immediately for release of product for sale in the U.S.
The new assay is indicated to be the first developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan's botulinum toxin type A product.
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.
"We are proud to have achieved this major scientific milestone in the development of a safe and effective alternative test capable of eliminating the need for an animal-based assay for BOTOX." said Scott Whitcup, Allergan's Executive Vice President, Research and Development and Chief Scientific Officer.
BOTOX is a unique and complex biological product with 21 different approved medical uses, and is derived from natural sources - in this case from the bacterium C. botulinum. BOTOX is Allergan's only product that has required use of an animal-based assay for stability and potency testing to ensure safe product use in humans.
AGN closed Friday's regular trade at $80.87, down $0.11 or 0.14%, on a volume of 1.6 million shares on the NYSE.
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