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Allergan Receives FDA Approval

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Allergan, Inc. (NYSE:AGN) announced Friday the United States Food and Drug Administration (FDA) has approved a fully in vitro, cell-based assay for use in the stability and potency testing of BOTOX® (onabotulinumtoxinA) and BOTOX® Cosmetic.  The newly approved assay will be implemented immediately for release of product for sale 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.  The new assay is the first to be developed and approved for any botulinum neurotoxin currently available worldwide, and is specifically applicable to Allergan’s botulinum toxin type A product. 

“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, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer.  “Following the FDA approval, we will work hard to secure approval of the new assay to replace the current animal testing requirements for the release and stability testing of BOTOX® and BOTOX® Cosmetic in countries in which we market and distribute the product.”

The FDA approval follows more than a decade of Allergan research and development and an approximately $65 million investment directed toward minimizing to the greatest degree possible the need for animal-based assays in the manufacture of BOTOX® and BOTOX® Cosmetic.  The mouse LD50 potency assay is required by the FDA, the Medicines and Healthcare products Regulatory Agency (MHRA) in Europe and regulatory agencies around the world for testing final product for release to assure its safety and efficacy.  Limitations associated with the current mouse LD50 assay, which has been the standard for potency and stability testing of BOTOX® and BOTOX® Cosmetic and other botulinum neurotoxin type A products, include the necessary involvement of animals due to the current structure of the assay, the complexity of the procedures involved, lack of specificity, as well as variability between assays and laboratories.

“The new cell-based potency assay we have developed for BOTOX® and BOTOX® Cosmetic has many advantages over current methods including the potential for greater precision and consistency in stability and potency testing, making this a significant breakthrough in both the science and manufacturing of neurotoxins,” said Timothy Terrell, DVM, Ph.D, DACVP, Allergan’s Senior Vice President, Drug Safety Evaluation. 

Currently all pharmaceutical manufacturers are required by the 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 21 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 BOTOX® Cosmetic 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® is Allergan’s only product that has required use of an animal-based assay for stability and potency testing, as mandated by global regulatory authorities to ensure safe product use in humans. 

About Allergan, Inc.

Allergan is a multi-specialty health care company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential.  Today, we have more than 9,000 highly dedicated and talented employees, global marketing and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing and safety surveillance that help millions of patients see more clearly, move more freely and express themselves more fully. From our beginnings as an eye care company to our focus today on several medical specialties, including ophthalmology, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate 60 years of medical advances and proud to support the patients and physicians who rely on our products and the employees and communities in which we live and work.

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