Allergan Receives Positive Opinion Through European Decentralised Procedure For BELKYRA® (Deoxycholic Acid) For Patients With Submental Fullness

DUBLIN, July 1, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that it has received a Positive Opinion from the Swedish Medical Products Agency (MPA) for BELKYRA^® (deoxycholic acid). BELKYRA^® will be the first prescription medicine to be licensed in Europe 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.¹ BELKYRA^® is being evaluated through the Decentralised Procedure, with the Swedish MPA acting as the Reference Member State for 20 other countries in the European Union, as well as Iceland and Norway.

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"We are delighted to receive the Positive Opinion from the Swedish Medical Products Agency (MPA) for BELKYRA^®, which provides men and women who are bothered by submental fullness with a new minimally invasive treatment option," said David Nicholson, Chief R&D Officer at Allergan. "Because of the extensive evidence behind the product, we see BELKYRA^® as a breakthrough treatment that will complement other aesthetic treatments. We look forward to our continued work with the 20 EU member states, Norway and Iceland to secure marketing authorizations to make this important new treatment option available to customers and patients."

Submental fullness (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 topped the list of most troublesome conditions for patients, with 67% reporting being concerned or bothered about the condition.² 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 aging, genetics or weight gain.³

"In my practice, I see many patients – both men and women – whose self-esteem has been negatively impacted by fullness under their chin; often the way they feel on the inside is contrary to what they see when they look in the mirror," said Leading Cosmetic Physician David Eccleston. "I would welcome the addition of a minimally invasive, clinically proven, authorized prescription medicine that meets Good Manufacturing Practice Standards to my practice, and it would give me confidence to be able to offer an effective and proven solution for double chin (submental fullness) to my patients."

"Once approved, BELKYRA^® will provide a complementary fit to our broader medical aesthetics portfolio. We are looking forward to bringing the product to market and training physicians on how to best use this new treatment," said Paul Navarre, President, Allergan International. 

BELKYRA^® has been the focus of a global clinical development programme involving over 20 clinical studies with more than 2,600 patients worldwide.⁴ Four phase III clinical studies have assessed the efficacy and safety of BELKYRA^® in adults with moderate to severe fullness under the chin; two in the US and two in Europe.¹ In the clinical studies, clinicians assessed that 63.8% of people treated with BELKYRA^® in the European studies and 78.5% of patients in the North America studies achieved a 1-grade improvement in the appearance of the area beneath their chin at 12 weeks after their last treatment. 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 their submental fullness (compared with 18% and 17.3% of people treated with placebo, respectively) during the same time period.¹ BELKYRA^® was generally well tolerated. Most side effects were mild or moderate in severity, primarily associated with the treatment area and resolved without intervention.⁵

As a next step, Allergan will work to secure the national Marketing Authorisations in the Concerned Member States. Once the national licenses have been granted, Allergan will begin to train healthcare professional customers on the safe and effective use of this new treatment. Allergan is already working with other health regulatory agencies around the world to bring this valuable treatment option to people with submental fullness. BELKYRA^® is already licensed in Canada, as well as in the U.S. as KYBELLA^®.

Note to Editors:
About Submental Fullness
A double chin is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance – frequently leading to an older and heavier look.⁶  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.^3,7 Submental fullness is the result of aging on the foundation of the skin, muscle, bone and fat.⁶

Countries Involved in the Decentralised Procedure
For BELKYRA^®, Sweden serves 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 expects to finalise the Marketing Authorisations and launch the product in most of these countries in the latter half of 2016 or early 2017.

About BELKYRA^® 
BELKYRA^® contains a non-human, non-animal version of deoxycholic acid which is identical to naturally-occurring deoxycholic acid. When injected into subcutaneous fat, BELKYRA^® causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat, so re-treatment is not expected once the patient's treatment goal is achieved.¹

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 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 BELKYRA® Summary of Product Characteristics. EU
² American Society for Dermatologic Surgery (ASDS). 2015 ASDS Consumer Survey on Cosmetic Dermatologic   Procedures. April 2015.
³ DeFatta R, Ducic Y. Liposuction of the face and neck. Operative Techniques in Otolaryngology. 2007; 18:261-266. 
⁴ Data on File: NDA Section 5.1, page 18.
⁵ BELKYRA® summary of clinical safety, pgs 61-62
⁶ 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, 445–453.  
⁷ 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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