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.
Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
"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
- ISAPS Global statistics 2014.
http://www.isaps.org/news/isaps-global-statistics Last accessed
May 2016
- ISAPS Global statistics 2010.
http://www.isaps.org/Media/Default/global-statistics/ISAPS-Results-Procedures-2010.pdf
Last accessed May 2016
- BOTOX Vista® 50 Units Japanese PI
- Web Allergan press release 2014.
http://www.multivu.com/mnr/7203552-allergan-inc-botox-25-th-anniversary.
Last accessed May 2016.
- Ref 1,2 – vial – trial pts
- Ref 3 – BTX studies
CONTACTS:
Investors:
Lisa DeFrancesco
+1 (862) 261-7152
Lisa.defrancesco@allergan.com
Media:
Mark Marmur
+1 (862) 261-7558
mark.marmur@allergan.com
Janet Kettels
+44 773 850 6476
Kettels_janet@allergan.com
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SOURCE Allergan plc