-- New indication for Allergan’s Market-Leading Neurotoxini Can Now Help Treat Three Facial Areasii --
-- First Step in Securing National Licenses in 30 European Countries --
DUBLIN, IRELAND – December 18, 2017 – Allergan plc (NYSE:AGN), a global biopharmaceutical company, today announced that VISTABEL® has received a Positive Opinion from the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) for the temporary improvement in the appearance of moderate to severe forehead lines in adults when the severity of the facial lines has an important psychological impact.ii This is an important step towards securing national licences in the 28 countries of the European Union as well as Norway and Iceland.
This positive opinion, which follows the recent approval by the U.S. Food and Drug Administration (FDA) for BOTOX® Cosmetic as a treatment for forehead lines, means that VISTABEL® is indicated for the temporary improvement in the appearance of moderate to severe forehead lines and/or glabellar (frown) lines and/or crow’s feet lines in adult patients when the severity of upper facial lines has an important psychological impact in adult patients.iii,iv This Positive Opinion is specific to Allergan’s botulinum toxin type A product and is based on Allergan’s international phase III studies in forehead and glabellar lines treated simultaneously.ii
“Allergan is proud to continue its leadership in medical aesthetics and this additional indication for VISTABEL® broadens the options available to practitioners when treating forehead lines. The appearance of horizontal lines caused by muscle contraction, especially on the forehead, can have a considerable impact on patients. Once licensed, Allergan will be able to train physicians effectively to improve the appearance of upper facial lines that worry their patients,” said Marc Princen, Executive Vice President and President, International Business at Allergan.
The Positive Opinion is based on the results of two randomised, placebo-controlled clinical studies involving more than 822 patients.ii Thirty days after treatment with VISTABEL® the proportion of patients achieving mild or no forehead lines at maximum eyebrow elevation was significantly greater than patients receiving placebo (p=0.0003).ii VISTABEL® injections significantly reduced the severity of forehead lines for up to six months (P<0.05) as seen at maximum eyebrow elevation compared to placebo. Treatment efficacy was measured by the proportion of patients achieving a forehead lines severity rating of none or mild at maximum eyebrow elevation in the two pivotal studies.ii
The recommended doses are based on clinical evidenceiii,v and all three areas were treated with VISTABEL 64U and evaluated simultaneously in one of Phase III studies, the severity of all three areas (GL, FHL, LCL) at maximum contraction was significantly reduced compared to placebo. Patients treated with VISTABEL 64U, saw statistically significant differences compared to placebo at their first post-treatment visits (week 1) and these remained significant through Day 120 of treatment cycle 1 (p≤0.0001).vi For a single administration of VISTABEL®, when treating all three facial areas simultaneously (forehead lines, glabellar lines and crow’s feet lines), the total dose is 64 units comprised of 20 units for forehead lines, 20 units for glabellar and 24 units for crow’s feet lines; these doses were shown to be statistically superior to placebo.iii
“VISTABEL® is a well established and trusted product that has been used widely in current practice for many years. The Positive Opinion of VISTABEL® for use in moderate to severe forehead lines is good news as it means dosing guidance will now be available for trained physicians prescribing and administering the treatment in the forehead. Correct dosing helps with optimum treatment duration and patient satisfaction,” said Dr. Koenradd De Boulle, Dermatologist at Aalst Dermatology Clinic in Belgium.
Patients treated with VISTABEL® reported improvements in how bothered they were by their forehead lines, looking older than their actual age and attractiveness compared to placebo at 30 days following treatment.vii Of patients treated with botulinum toxin type A for forehead, glabellar and crow’s feet lines, 68.8% who previously rated themselves as looking their current age or older, believed they looked younger up to six months after treatment at day 30 (p<0.0001)vii In the same study, 83% of patients believed they looked more attractive up to six months after treatment (p≤0.0073) compared to placebo.vii
In these studies, Allergan’s botulinum toxin type A product was generally well tolerated. Like all medicines, Allergan’s botulinum toxin type A product may cause side effects although in general, adverse reactions occurred within the first few days following injection and were mild or moderate in severity and temporary.viii Please refer to the VISTABEL® Summary of Product Characteristics for full list of side effects.
Allergan: Nana Hilbourne
+44 (0) 1628 494 415
Media: Abigail Last
+44 (0) 7773 483 879
Notes to Editors
VISTABEL® (botulinum toxin type A) is a prescription medication that works by temporarily relaxing the specific muscles that cause crow’s feet lines, glabellar lines or forehead lines to form. By decreasing muscle activity, it’s possible to temporarily soften the appearance of these lines and wrinkles.ix
About Allergan’s botulinum toxin type A
Allergan’s botulinum toxin type A is a prescription-only medical product that contains tiny amounts of a purified botulinum toxin protein refined from the bacterium, Clostridium botulinum.viii,ix
Over the past 26 years, approximately 68 million vials of Allergan’s botulinum toxin type A for cosmetic and therapeutic use, have been distributed worldwide (1990-2016). In addition, the safety and efficacy of Allergan’s botulinum toxin type A have been well- established in 81 randomised, placebo-controlled clinical trials and in approximately 19,000 patients and, with more than 3,200 articles in scientific and medical journals, Allergan’s neurotoxin is one of the most widely researched medicines in the world.x
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women’s health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 55+ mid-to-late stage pipeline programs currently in development.
Allergan’s success is powered by our more than 18,000 global colleagues’ commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended September 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
i Allergan Data on file. INT/0827/2017. Allergan BOTOX market share report
ii Allergan Data on file. INT/0866/2017e. Vistabel FHL Positive Opinion DoF FVAR
iii VISTABEL® 4 Allergan Units/0.1 ml, Powder for solution for injection - Summary of Product Characteristics (SPC), December 2017.
iv PRNewswire.com. (2017). FDA Approves BOTOX® Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines Associated with Frontalis Muscle Activity In Adults. [online] Available at: https://www.prnewswire.com/news-releases/fda-approves-botox-cosmetic-onabotulinumtoxina-for-the-temporary-improvement-in-the-appearance-of-moderate-to-severe-forehead-lines-associated-with-frontalis-muscle-activity-in-adults-300529648.html [December 2017]
v Solish N. Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial. Surg: 2016; 42:410-419
vi Allergan Data on file. INT/0866/2017f. Vistabel FHL Positive Opinion DoF Clinical study summary: 191622-143
vii Allergan Data on File. INT/0681/2017c. September 2017
viii Medicines.ie. (2015). VISTABEL® 4 Allergan Units/0.1 ml, Powder for solution for injection – Summary of Product Characteristics (SPC). [Online] Available at: http://www.medicines.ie/medicine/14328/SPC/Vistabel/ [November 2017]
ix Brin, M. F., James, C., & Maltman, J. (2014). Botulinum toxin type A products are not interchangeable: a review of the evidence. Biologics: targets & therapy, 8, 227. Chicago
x Allergan Data On File. INT/0681/2017a. September 2017