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

DUBLIN, May 23, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare has approved an additional use for BOTOX Vista® (Allergan's botulinum toxin type A product) as a treatment for crow's feet lines (CFL).³ BOTOX Vista® is now indicated for the temporary improvement in the appearance of lateral canthal lines (CFL) in adult patients under the age of 65.³ This marketing authorisation is specific to Allergan's botulinum toxin type A product.

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"Our market research has shown that women in Japan have a strong desire to look fresh and revitalised as they age, and they want to do it in a natural way," says Rajkumar Narayanan, Senior Vice President & President of Asia Pacific, Allergan International. "When administered by a trained aesthetic practitioner BOTOX Vista® allows women to achieve the natural-look they want. Achieving this milestone and gaining marketing authorisation for CFL in Japan demonstrates Allergan's ongoing commitment to physicians, patients and to our Medical Aesthetics business worldwide."

"CFL are one of the main ageing concerns for many patients around the world, men and women. Whilst these lines form part of our natural eye expression, over time they can become fixed or elongated, even when our faces are relaxed, which can make us look tired or unhappy," said Dr. Furuyama Nobutaka, Japan. "By subtly softening the appearance of CFL and glabellar lines combined with BOTOX Vista®, we can deliver a refreshed and natural look, helping patients to look like themselves again and improve their self-confidence."

The licence for BOTOX Vista® to treat CFL is based on a phase 3 clinical study in Japan involving 300 patients.³ Of the patients who received a single dose of BOTOX Vista® at 12 units or 24 units, over 56.5% and 68.3% respectively achieved an improvement of the appearance of CFL at day 30, compared to those patients who did not receive botulinum toxin type A treatment (8.2% with placebo).³ In a second phase 3 study patients received concurrent treatment of CFL (12 units or 24 units) and glabellar lines (20 units) with BOTOX Vista® in up to 4 treatment cycles. More than 80% of patients reported an improvement in the appearance of CFL at day 30 after each treatment cycle.³  In both studies, adverse reactions were limited and Allergan's botulinum toxin type A product was generally well tolerated.³

Allergan is the global leader in the toxin market with over 25 years of history and experience.⁴ Allergan's BOTOX® product was first approved for therapeutic use by the U.S. FDA in 1989, making it the first botulinum toxin type A product to be approved in the world. It has since been recognized by regulatory authorities as an effective treatment for 26 indications in approximately 94 countries worldwide and is in clinical development for a number of other potential aesthetic uses as well.     

Notes to Editor

About BOTOX^®
BOTOX® is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. When injected at the recommended doses into a specific muscle or gland, BOTOX® neurotoxin is expected to produce a safe, as well as effective result, usually lasting up to approximately three to 10 months, depending on the approved indication and on the individual patient.

Over the past 25 years, approximately 61 million vials of BOTOX® and BOTOX® Cosmetic have been distributed worldwide (1990-2015).⁵ In addition, the safety and efficacy of BOTOX® have been well- established in 81 randomized, placebo-controlled clinical trials and in approximately 19,000 patients treated with BOTOX® and BOTOX® Cosmetic in Allergan's clinical trials.⁵ With more than 3,200 articles on BOTOX® and BOTOX® Cosmetic published in scientific and medical journals,⁶ BOTOX® neurotoxin is one of the most widely researched medicines in the world.

^© 2016 Allergan. ®marks owned by Allergan. APC52KS16

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercialising innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

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.

For more information, visit Allergan's website at www.allergan.com.

Allergan Forward-Looking Statement
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 of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. 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; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

References

1. ISAPS Global statistics 2014. http://www.isaps.org/news/isaps-global-statistics Last accessed May 2016
2. ISAPS Global statistics 2010. http://www.isaps.org/Media/Default/global-statistics/ISAPS-Results-Procedures-2010.pdf Last accessed May 2016
3. BOTOX Vista® 50 Units Japanese PI
4. Web Allergan press release 2014. http://www.multivu.com/mnr/7203552-allergan-inc-botox-25-th-anniversary. Last accessed May 2016.
5. Ref 1,2 – vial – trial pts
6. Ref 3 – BTX studies

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