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 BELKYRA™
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
About KYBELLA®
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.
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.
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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CONTACTS:
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Allergan:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(862)
261-7558
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SOURCE Allergan plc