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10.02.2015 | Investors

KYBELLA® Injection Wins Allure Magazine "Best of Beauty" Award

The First and Only FDA-approved Injectable Treatment for "Double Chin" Recognized as "2015 Breakthrough" at Allure Awards Ceremony

DUBLIN, Oct. 2, 2015 /PRNewswire/ -- Allergan, plc (NYSE: AGN) is pleased to announce that KYBELLA® (deoxycholic acid) injection, the first and only FDA-approved injectable treatment for improving the appearance of moderate to severe submental fullness, also known as "double chin," received a "2015 Breakthrough Award" from Allure Magazine. The publication honored KYBELLA®, along with other winners from their annual "Best of Beauty" list, which included hundreds of luxury, mass market and specialty beauty and aesthetic brands, on September 21 at an awards ceremony held at One World Trade Center in New York.

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Products compete to receive the coveted beauty award, and undergo rigorous analysis by Allure editors and top industry experts such as dermatologists, cosmetic chemists and makeup artists.

"It is an honor to receive this prestigious award and to have KYBELLA® recognized as a beauty breakthrough by the world-renowned experts at Allure," said David Moatazedi, Vice President, Sales and Marketing U.S. Facial Aesthetics at Allergan.  "We are proud to offer men and women seeking a non-surgical approach to improve their chin profile a first-in-class aesthetic treatment with results supported by science and high patient satisfaction."

As the first and only FDA-approved injectable drug that improves the appearance of moderate to severe submental fullness due to submental fat in adults, KYBELLA® has generated significant interest from the aesthetic community, consumers and the media since its FDA approval in April 2015.

KYBELLA® is administered by injections into the fat under the chin, tailored to the overall treatment goals of the patient and the physician. Patients are assessed before each treatment session; this includes ensuring there is sufficient submental fat...[1] Up to six treatments may be administered, which are typically 15-20 minute sessions scheduled at least one month apart. Once the aesthetic response is achieved with KYBELLA®, retreatment is not expected.

The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema and formation of areas of hardness around the treatment area.

Health care practitioners and consumers can visit www.mykybella.com for further product and prescribing information.

Important Safety Information

KYBELLA® should only be administered by a trained healthcare professional.

KYBELLA® is contraindicated in the presence of infection at the injection sites.

Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials. KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve; all cases resolved spontaneously (range 1-298 days, median 44 days).

Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area; all cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Avoid use of KYBELLA® in these patients as current or prior history of dysphagia may exacerbate the condition.

In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.

To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.

The most commonly reported adverse reactions in the pivotal clinical trials were injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.

About Submental Fullness

Submental fullness, also referred to as double chin, is a common yet under-treated condition that can detract from an otherwise balanced and harmonious facial appearance[2] – leading to an older and heavier look.[3] Submental fullness can affect adults – both women and men – of all ages, weight and gender. Influenced by multiple factors including aging and genetics, submental fullness is often resistant to diet and exercise.

About KYBELLA®

KYBELLA® is the first and only approved injectable drug for contouring moderate to severe submental fullness, a condition that is commonly referred to as a double chin. KYBELLA® is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat.[4] When injected into subcutaneous fat, KYBELLA® causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.[5]

KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.

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 commercializing 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.

Forward-Looking Statements

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 risks associated with acquisition transactions; the difficulty of predicting the timing or outcome of FDA and other regulatory 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 June 30, 2015 (such periodic public filings having been filed under the "Allergan plc" or "Actavis plc" names) and from time to time in Allergan's other investor communications . Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

[1] KYBELLA Prescribing Information April 2015. 
[2] Swift A, Remington K. BeautiPHication: a global approach to facial beauty. Clin Plast Surg. 2011; 38:347-77.
[3] Dayan S. Neck rejuvenation. In: Hirsch, Aesthetic Rejuvenation: A Regional Approach. 1st ed. New York, NY: McGraw Hill Professional Publishing; 2008: 123-147.
[4] Stryer L, ed. Biochemistry. 4th Edition. New York, NY: WH Freeman and Co.; 1995: 691-707.
[5] FDA Approved Package Insert April 2015.

CONTACTS: 
Investors:
Lisa DeFrancesco  
(862) 261-7152

Media:
Mark Marmur
(862) 261-7558

Ember Garrett
(714) 246-3525

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SOURCE Allergan plc

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