Allergan's BELKYRA® (Deoxycholic Acid) Receives Marketing Authorisation In Sweden For The Treatment Of Moderate To Severe Fullness Under The Chin (Double Chin)

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DUBLIN, Oct. 13, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) a leading global pharmaceutical company, announced that Sweden has received the Marketing Authorisation for BELKYRA® (deoxycholic acid) after being granted approval by the Swedish Medical Products Agency (MPA). BELKYRA® is a prescription medicine for the treatment of moderate-to-severe convexity or fullness associated with submental fat (often called double chin) in adults when the presence of submental fat has a psychological impact for the patient.³ Fullness under the chin can impact how a person feels about themselves and, for both women and men, can lead to feelings of negative self-impression.⁴

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"BELKYRA® provides physicians with one of the first clinically evaluated and approved treatments for their patients who are bothered by fullness under the chin. We are very excited to receive the marketing authorisation for BELKYRA^® in Sweden and we are expecting more countries to follow in the next months," said Bill Meury, Chief Commercial Officer, Allergan. "We believe BELKYRA® will be a breakthrough treatment in Europe, as it has been in the United States and Canada, and it complements our established medical aesthetics portfolio. We look forward to introducing BELKYRA^® to other countries around Europe over the coming months, as we secure the additional national approvals."

BELKYRA® is the only non-surgical injectable treatment for reduction of fullness under the chin that has undergone rigorous clinical evaluation, including four Phase 3 clinical studies involving more than 2,600 patients worldwide.⁵ Until now, treatment options for submental fullness have been limited to surgical options such as liposuction and non-surgical in-clinic procedures using handheld devices or aggressive weight-loss regimens with potentially limited improvement.⁶ When injected into fat under the chin, BELKYRA^® permanently causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.¹

Fullness under the chin (or double chin) is a concern for many people. In fact, according to data from the American Society for Dermatologic Surgery (ASDS) in 2015, fat under the chin/neck was one of the top troublesome conditions for patients, with 67% reporting being concerned or bothered about the condition.³ This is similar in number to the percentage of people who are bothered by lines and wrinkles.³ There is a common misperception that fullness under the chin only appears in those who are overweight, when in reality it can occur in any body type and may be related to ageing, genetics or weight gain.⁷ 

"In my practice, I see many patients – both women and men – who were bothered by their double chin but who were reluctant to undergo surgery," said Shannon Humphrey, Cosmetic Dermatologist at Carruthers & Humphrey Cosmetic Dermatology, Vancouver, Canada and BELKYRA® Clinical Investigator. "In the few months since BELKYRA® was approved by Health Canada, many of my current patients have started treatment, and it's also opened a door for patients who have never seen an aesthetic practitioner before but who are concerned about their double chin. BELKYRA® has been a valuable addition to my treatment portfolio, as I can offer patients new ways to achieve the results they desire."

Treatment with BELKYRA^® takes place in-clinic by a trained medical aesthetic physician. Many people experience improvement after two to four treatment sessions spaced at least 4 weeks apart. A maximum of six treatments may be given.³ A patient's physician will carry out a full facial assessment to help them determine how many treatment sessions they may need based on the amount and distribution of the fat under their chin and their personal treatment goals.³

Four phase III clinical studies have evaluated the efficacy and safety of BELKYRA^® in adults with moderate-to-severe fullness under the chin; two in North America and two in Europe.³ In these studies, BELKYRA^® was shown to have a high overall efficacy rate, demonstrated by a 1-grade improvement in fullness under the chin as assessed by the clinician in the study at 12 weeks after the last treatment (63.8% in European studies and 78.5% in the North American studies, respectively). Importantly, 44.6% of people treated with BELKYRA^® in the European studies and 48.6% in the North American studies reported improvement in the psychological impact due to the fullness under their chin (compared with 18% and 17.3% of people treated with placebo, respectively) during the same time period.³ In the clinical studies, BELKYRA^® was generally well tolerated. Most side effects (including injection site pain/swelling and bruising) were mild or moderate in severity, primarily associated with the treatment area and resolved without intervention.⁸

As a next step, Allergan will begin to train appropriate healthcare professionals on the safe and effective use of this new treatment to ensure optimal patient satisfaction and outcomes.

BELKYRA® was evaluated through a Decentralised Procedure, with the Swedish agency (MPA) acting as the Reference Member State and included 20 other countries in the European Union, as well as Iceland and Norway.  Allergan will continue to work with other health regulatory agencies around the world to bring this valuable treatment option to people with fullness under the chin. BELKYRA^® is already licensed in Canada, Australia, Iceland, Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria and Norway, as well as in the U.S. as KYBELLA®.

Note to Editors:
Countries Involved in the Decentralised Procedure
For BELKYRA®, Sweden served as the Reference Member State in the Decentralised Procedure. The other 22 Concerned Member States are Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovenia, Slovakia and Spain. Allergan has now received the Marketing Authorisation in Iceland, Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria and Norway. Allergan will launch the product in the other cluster of countries in the latter half of 2016 or early 2017, following additional approvals.

About Submental Fullness (or double chin)
Fullness under the chin, or a double chin, can detract from an otherwise balanced and harmonious facial appearance ⁹ frequently leading to an older and heavier look which can impact how a person feels about themselves and lead to feelings of negative self-impression.⁴ The condition can affect adults – both women and men – of all ages, weight and gender. Influenced by multiple factors including ageing and genetics, fullness under the chin is often resistant to diet and exercise.^7,10

About BELKYRA^®
BELKYRA^® contains a synthetic version of deoxycholic acid¹ which imitates naturally-occurring deoxycholic acid.² When injected into subcutaneous fat, BELKYRA^® causes the destruction of fat cells.¹ Once destroyed, those cells cannot store or accumulate fat.¹

About Allergan
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 pharmaceuticals, devices and biologic 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, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.

Our Company's success is powered by our more than 16,000 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.

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

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 Annual Report on Form 10-K for the year ended December 31, 2015 and 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. Rzany B, et al, Reduction of unwanted submental fat with ATX-101 (deoxycholic acid), an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study*. British Journal of Dermatology. 2014; 170, pp445–453
2. American Society for Dermatologic Surgery (ASDS). 2015 ASDS Consumer Survey on Cosmetic Dermatologic Procedures. April 2015.
3. BELKYRA^® Summary of Product Characteristics.
4. Ascher B, et al Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study. Journal of the European Academy of Dermatology and Venereology. 2014; 28(12)
5. Belkyra Data on File 01: INT/0532/2016
6. McDiarmid J. Results from a Pooled Analysis of Two European, randomized, Placebo-Controlled, Phase 3 Studies of ATX-101 for the Pharmacologic Reduction of Excess Submental Fat. Aesthetic Plastic Surgery. 2014; 38(5)
7. DeFatta R, Ducic Y. Liposuction of the face and neck. Operative Techniques in Otolaryngology. 2007; 18:261-266.
8. Allergan Data on file 02: INT/0533/2016
9. Rohrich R, et al. Neck Rejuvenation Revisited. Plastic and Reconstructive Surgery. 2006; 118, Number 5.
10. Schlessinger J et al, Perceptions and Practices in Submental Fat Treatment: A Survey of Physicians and Patients. SKINmed. 2013;11:27-31

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