Allergan's BOTOX® (botulinum toxin type A) Receives National Marketing Authorisation for Treatment of Moderate to Severe Crow's Feet Lines in Adult Patients

MARLOW, England, January 9, 2014 /PRNewswire/ --



New aesthetic indication for market-leading neuromodulator which can now help improve appearance of lines around the eyes, as well as treating glabellar frown lines

Today, Allergan, Inc. announced that BOTOX® has received the licence from the Medicines and Healthcare products Regulatory Agency (MHRA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet lines) seen at maximum smile, either alone or when treated at the same time as glabellar (or frown) lines seen at maximum frown, in adult patients where these facial lines have an important psychological impact. This marketing authorisation is specific to Allergan's botulinum toxin type A product and is based on Allergan's successful global Phase III clinical trial programme in Crow's Feet Lines.

"This latest approval for BOTOX® demonstrates Allergan's continued commitment to excellence in neuromodulator innovation and our long-term leadership in medical aesthetics," said Paul Navarre, President of Allergan Europe, Africa & Middle East. "We are proud to deliver this important innovation to medical aesthetics practitioners in the UK, allowing them for the first time to treat the glabellar and crow's feet areas either alone or simultaneously."

The MHRA licence for the use of BOTOX® to treat crow's feet lines is based on the results of two randomised, multi-centre, placebo-controlled clinical studies involving more than 1,350 patients.^[1] These studies met their primary endpoint, demonstrating that patients who received treatment with BOTOX® achieved none or mild lines according to investigator assessment at day 30, compared to those patients who did not receive botulinum toxin type A treatment and this significant reduction in the appearance of crow's feet lines lasted an average of four months post-treatment.^[1] In general, patients treated with BOTOX® reported that they looked younger and more attractive.^[1] In these studies, Allergan's botulinum toxin type A product was generally well tolerated.^[1] Like all medicines, Allergan's botulinum toxin type A product may cause side effects, although the incidence rate is variable. In general, adverse reactions occurred within the first few days following injection and were temporary.^[1]

"Crow's Feet Lines are amongst the top ageing concerns for people in the UK and Europe. Whilst these lines form a natural part of our eye expressions, over time they can become fixed or elongated even when our faces are relaxed, which can make us look tired or stressed," said David Eccleston, Clinical Director, MediZen Clinic. "Softening the appearance of Crow's Feet Lines as well as the glabellar lines with BOTOX® can deliver a refreshed and natural look, helping patients to look like themselves again and improve their self-confidence."

Notes to Editor

About BOTOX®

BOTOX® (botulinum toxin type A) is a prescription medication that works by relaxing the specific muscles that cause crow's feet lines or frown lines to form. By decreasing muscle activity, it's possible to soften the appearance of these lines and wrinkles without radically changing facial appearance or making a patient look as if they have had "work done". The temporary effect lasts for up to four months.^[1] Patient satisfaction data shows that following treatment with BOTOX®, patients reported looking more relaxed and confident, as well as looking as young as they feel.^[2] BOTOX® should only be administered in a clinical setting by an appropriately trained physician.

About Allergan's botulinum toxin type A

Worldwide, approximately 35 million vials of Allergan's botulinum toxin type A products have been distributed over the past 21 years (1990-2012). The safety and efficacy of Allergan's botulinum toxin type A product has been well-established with approximately 65 randomised, placebo-controlled clinical trials involving approximately 15,000 patients and, with more than 2,500 articles in scientific and medical journals, Allergan's neurotoxin is one of the most widely researched medicines in the world.^[3]

About Allergan

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 approximately 11,100 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 eye care, neurosciences, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention and urologics, Allergan is proud to celebrate more than 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.

Forward‐Looking Statement

This press release contains "forward‐looking statements", including but not limited to the statements by Mr Paul Navarre and Mr David Eccleston and other statements regarding the use of BOTOX® to treat Crow's Feet Lines. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.  Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2012 Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q.  

© Allergan, Ltd. BOTOX® is a registered trademark owned by Allergan Inc.

References

1. UK SmPC for BOTOX® 50 Units

2. Stotland MA et al. J Plas Recons Surg: 2007; 120(5):1386-1393

3. Allergan Data On File