-- KYBELLA® First FDA-Approved Non-Surgical Injection for Submental Fullness Bolsters Allergan's World-Class Facial Aesthetics Portfolio --
-- Acquisition Adds Setipiprant (KYTH-105), Novel Compound and Potential Treatment for Male Pattern Hair Loss --
-- Acquisition Positions Allergan Aesthetics Portfolio for Significant Market Opportunity in Growing Use of Aesthetics Products by Men --
DUBLIN, Oct. 1, 2015 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that it has successfully completed the acquisition of Kythera Biopharmaceuticals, Inc., a company focused on the discovery, development and commercialization of novel prescription products for the medical aesthetics market. Allergan acquired Kythera in an all-cash transaction valued at approximately $2.1 billion.
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The acquisition of Kythera adds KYBELLA® (deoxycholic acid) injection, the first FDA approved non-surgical injection for improvement in the appearance of moderate to severe submental fullness, commonly referred to as double-chin, in adults. KYBELLA is administered by a trained physician who injects the product under a patient's chin to destroy fat cells, improving the appearance of the patient's chin area. Up to six treatments may be administered per patient no less than one month apart, and each in-office treatment session lasts approximately twenty minutes.
"The completion of the Kythera acquisition is an important moment for Allergan and our world-class aesthetics business, adding highly differentiated products and development programs that enhance our product offering to global customers and their patients," said Brent Saunders, CEO and President of Allergan. "KYBELLA is a game-changing product in facial aesthetics, and builds on our leadership in the facial aesthetics market. We now can provide a broader range of market-leading aesthetics products to our customers, with KYBELLA joining BOTOX® Cosmetic, JUVEDERM® XC, JUVEDERM VOLUMA® XC and LATISSE®. KYBELLA, a product I have been treated with myself, is also a key entry point for expanding the use of our aesthetics products in men, a growing market opportunity in both the U.S. and around the world."
KYBELLA has been studied as part of a global clinical development program involving more than 20 clinical studies with more than 1,600 patients treated. KYBELLA was approved by the U.S. Food and Drug Administration (FDA) on April 29, 2015 and launched on June 19, 2015. Internationally, Kythera recently received marketing authorization from Health Canada for KYBELLA (marketed as BELKYRATM in Canada) for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults. Kythera also recently announced the submission of a Marketing Authorization Application (MAA) in the European Union (EU), seeking approval for ATX-101 (deoxycholic acid) injection as a treatment for the reduction of submental fat when the presence of submental fat has a psychological impact for the patient. Additionally, Allergan will pursue the relevant clinical trial requirements and the regulatory pathways to license and commercialize this treatment in other countries.
"In my practice, I see many patients - both men and women of varying ages - who complain about submental fullness of the chin, even those who have an otherwise balanced facial appearance, eat healthy and are physically fit. This condition is many times resistant to lifestyle changes such as diet and exercise, and may simply be a result of the aging process or a patient's genetics," said Dr. Derek H. Jones, Associate Professor of Dermatology, UCLA, Founder and Medical Director, Skin Care and Laser Physicians of Beverly Hills. "KYBELLA offers a new, exciting option for medical aesthetics professionals and their patients who are seeking a non-surgical option for the bothersome condition of double-chin."
The acquisition also adds KYTHERA's development product setipiprant (KYTH-105), a novel compound for the prevention of androgenetic alopecia (AGA), or male pattern hair loss, as well as additional early-stage development candidates. KYTHERA has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for setipiprant for the treatment of AGA. Allergan plans to conduct a human proof-of-concept study to evaluate the efficacy and safety of setipiprant in male subjects with AGA.
About Submental Fullness
Submental fullness is a common yet undertreated condition that can detract from an otherwise balanced and harmonious facial appearance - leading to an older and heavier look. 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. According to a 2015 survey by the American Society for Dermatologic Surgery, 67 percent of consumers are bothered by submental fullness.i
KYBELLA® is the first FDA approved non-surgical injection for improving the appearance of moderate to severe submental fullness, commonly referred to as 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. When injected into subcutaneous fat, KYBELLA® causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.
KYBELLA® (deoxycholic acid) injection 10 mg/mL 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.
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 during clinical trials. To avoid the potential for nerve injury, KYBELLA should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve. All marginal mandibular nerve injuries reported from the trials resolved spontaneously (range 1-298 days, median 44 days).
Difficulty swallowing (dysphagia) occurred in the clinical trials in the setting of administration site reactions, e.g., pain, swelling, and induration of the submental area. Cases of dysphagia spontaneously resolved (range 1-81 days, median 3 days). Subjects with current or prior history of dysphagia were excluded from clinical trials. 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 injection site 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. Please see full Prescribing Information.
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.
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.
i American Society For Dermatologic Surgery 2015 Consumer Survey on Cosmetic Dermatologic Procedures (N=7315); Exact survey language was "How bothered are you by excess fat under the chin/neck?"
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SOURCE Allergan plc