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A meeting between the ECEAE (European Coalition to End Animal Experiments) and executives from Allergan has been declared as positive and productive.
The meeting which took place recently in London was held to discuss the significant progress made by Allergan, the leading manufacturer of botulinum toxin products, towards ending the use of mice for the commercial release of BOTOX® and VISTABEL® (Allergan’s brands of botulinum toxin type A in Europe). A recent announcement by Allergan that the U.S. Food and Drug Administration has approved a non-animal, cell-based assay for use in the stability and potency testing of its leading brands (BOTOX® and BOTOX® Cosmetic) has already been welcomed by the ECEAE. Allergan has stated that this will enable the company to reduce animal testing of BOTOX®, BOTOX® Cosmetic and VISTABEL® by up to 95% in three years. The meeting with Allergan confirmed the company aims to end animal testing for the commercial (batch) release of BOTOX®, Botox Cosmetic and VISTABEL® once all stages of regulatory approval has been cleared.
Botulinim toxin is licensed in the EU as a medical treatment mainly for relatively rare conditions, but it is more commonly known for its use in cosmetic procedures. The traditional animal test for the batch release of all botulinum products, regardless of end use, to date uses several hundred mice per batch of botulinum toxin, and is designed like the Lethal Dose 50 (LD50) tests. LD50 tests determine the dose at which 50% of the mice would die and involve severe suffering for the animals. Mice are injected into their abdominal cavities with the toxin and then, over three days, are observed to see if they have died or are showing signs that they will die shortly from the toxin. Regulators worldwide currently require LD50 testing before the commercial batch release of botulinum toxin products for use in humans.
During the meeting, Allergan discussed their research which led to a validated, fully in-vitro cell-based potency assay. They also discussed their plans to work with the European medicines regulators so that this assay can be used for the commercial batch release of BOTOX® and VISTABEL® vials sold in Europe. The company confirmed they have already filed for approval throughout the EU. It’s important to note that this assay is specific for the products made and sold by Allergan (BOTOX®, BOTOX® Cosmetic and VISTABEL®) and does not apply to other botulinum toxins. In the US, Allergan have already made the switch and has started selling BOTOX® and BOTOX® Cosmetic that has been tested using the alternative method.
The ECEAE have long campaigned for an end to the cruel use of animals in botulinum toxin tests and welcomed the chance to discuss the next steps in this effort with Allergan.
Michelle Thew, Chief Executive, ECEAE stated: “We were pleased for the opportunity to meet with Allergan. The use of mice to test botulinum toxin is an issue of strong public concern and we welcome this development by Allergan of a non-animal alternative for its batch release testing and the resulting large reduction in animal testing that is foreseen. This is a significant step forward. Allergan has shown that it is possible to replace the cruel mouse bioasssay. We now call on the European medicines regulators and other companies manufacturing botulinum toxin products, including Ipsen and Merz, to follow suit.”
Douglas Ingram, President of Allergan Europe, Africa and the Middle East commented: “As a company, we have been deeply committed to finding an alternative assay to the LD50 tests for BOTOX®, BOTOX® Cosmetic and VISTABEL and have dedicated more than $60 million dollars and a decade of research and development to this challenge. The breakthrough from our scientists, currently being evaluated by the health agencies in Europe, will allow us to offer the only botulinum toxin products that do not require animal testing for commercial release.”