Allergan's cell-based assay for botulinum toxin type A products receives positive opinions

Allergan is pleased to announce the company has received two positive opinions regarding its fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® and VISTABEL® (Allergan's botulinum toxin type A products). Upon approval, the new assay will be implemented as quickly as possible for the release of product for sale in the relevant countries. Allergan estimates that use of the new assay will reduce the use of animal-based assay testing for BOTOX® and VISTABEL® by 95 percent or more over the next three years, as other regulatory agencies around the world approve this new assay. The result of years of research and development commitment, this new assay is the first to be developed and approved for any botulinum toxin currently available worldwide and is specific to Allergan's botulinum toxin type A products, BOTOX® and VISTABEL®. This approval does not extend to botulinum toxins made by other manufacturers, who will continue to use their animal-based release assays.

“I know that my patients will welcome this initiative, and that they will continue to feel confident about the ethos and efficacy of these products. The time has definitely come for people interested in medical aesthetics to select very carefully what is used to treat them.”

The first positive opinion, from Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), relates to VISTABEL® and paves the way for approval in 29 countries in the European Union. The second positive opinion was granted by the Irish Medicines Board (IMB) for BOTOX® and covers 14 European Union countries involved in the Mutual Recognition Process. The Medicines and Healthcare products Regulatory Agency (MHRA) have already approved the assay for BOTOX® vials sold in the UK.

"We are pleased that Allergan has achieved these significant milestones with the European regulators for the first non-animal based assay for the potency and stability testing of BOTOX® and VISTABEL®. This represents a significant scientific breakthrough in the manufacturing of neurotoxins and is the right and necessary step forward in eliminating the use of animals for release of the product. Allergan's cell-based assay now sets the standard for all other botulinum toxin manufacturers and demonstrates that with commitment and perseverance, it is possible to find validated, robust alternative methods of testing medicines while maintaining the highest level of patient safety. We now call on other companies manufacturing botulinum toxin products, including Ipsen and Merz, to follow Allergan's ethical lead," said Michelle Thew, Chief Executive of the British Union for the Abolition of Vivisection (BUAV).

These approvals follow more than a decade of Allergan research and development and an investment of approximately $65 million directed toward minimizing to the greatest degree possible the need for animal-based assays in the manufacture of BOTOX® and VISTABEL®. Until Allergan's cell-based assay, the mouse LD₅₀ potency assay has been the standard for potency and stability testing for all botulinum toxin products and was required by regulatory agencies around the world for testing final product for release to assure its safety and efficacy. Limitations associated with the mouse LD₅₀ assay include the necessary involvement of animals due to the current structure of the assay, the complexity of the procedures involved, lack of specificity to botulinum toxin type A, as well as variability between assays and laboratories.

"We are proud to have achieved this major scientific milestone demonstrating how BOTOX® and VISTABEL® are leading the way in toxin innovation," said Douglas Ingram, President of Allergan in Europe, Africa and the Middle East. "The decisions by the MHRA, AFSSAPS and the IMB will allow us to replace the current animal testing requirements with the new cell-based assay for the release and stability testing of BOTOX® and VISTABEL®. Along with the relevant European regulatory agencies, we are committed to securing national approvals and releasing the product using the new assay as rapidly as possible."

Currently all pharmaceutical manufacturers are required by the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and by other worldwide health regulatory agencies to protect patients and consumers by assuring product safety and efficacy through animal testing and other methods. BOTOX® is a unique and complex biological product with many different approved medical uses, and is derived from natural sources - in this case from the bacterium C. botulinum. When manufacturing biological products, testing is particularly critical to ensuring the consistent safety and efficacy of each batch of product. BOTOX® and VISTABEL® are the same product, manufactured in exactly the same way, and therefore the potency and stability of each batch must be determined before release, regardless of whether the batch is intended for medical or aesthetic use. BOTOX® and VISTABEL® are Allergan's only products that have required use of an animal-based assay for commercial release, as mandated by global regulatory authorities to ensure safe product use in humans.

"I applaud Allergan's long-term dedication to putting research and patient safety before profit in developing a ground-breaking new method for testing BOTOX® and VISTABEL®" said Mr Rajiv Grover, Consultant Plastic Surgeon, King Edward VII Hospital in London and President Elect of the British Association of Aesthetic Plastic Surgeons. "I know that my patients will welcome this initiative, and that they will continue to feel confident about the ethos and efficacy of these products. The time has definitely come for people interested in medical aesthetics to select very carefully what is used to treat them."