DUBLIN and WESTLAKE VILLAGE, Calif., July 27, 2015 /PRNewswire/ -- Allergan plc (NYSE:
AGN) and KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) today
announced that the U.S. Federal Trade Commission (FTC) has granted
early termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (HSR Act) with respect to
Allergan's pending acquisition of KYTHERA.
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On July 6, 2015, each of Allergan
and KYTHERA filed a Pre-Merger Notification and Report Form
pursuant to the HSR Act with the Antitrust Division of the U.S.
Department of Justice and the FTC.
The early termination of the waiting period under the HSR Act
satisfies one of the conditions to the closing of the pending
acquisition, which remains subject to other customary closing
conditions, including receipt of approval by KYTHERA's
stockholders.
About KYBELLA™
KYBELLA™ is the first and only approved non-surgical treatment
for contouring 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 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
http://www.allergan.com.
About KYTHERA®
KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery, development and commercialization of
novel prescription products for the aesthetic medicine market. In
addition to its lead product KYBELLA™, KYTHERA also licensed the
worldwide rights to setipiprant (KYTH-105), an early-stage
potential treatment for hair loss. KYTHERA's longer-term strategy
is to leverage its biotechnology and aesthetics experience to
expand its product portfolio and pipeline. KYTHERA has received
regulatory approval for BELKYRA™ in Canada and has submitted regulatory filings
for ATX-101 in Switzerland and
Australia. Find more information
at http://www.kythera.com.
Allergan Cautionary Statement Regarding Forward-Looking
Statements
Statements contained in this communication that refer to
Allergan's estimated or anticipated future results 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 communication. Forward looking statements
generally will be accompanied by words such as "anticipate,"
"believe," "plan," "could," "should," "estimate," "expect,"
"forecast," "outlook," "guidance," "intend," "may," "might,"
"will," "possible," "potential," "predict," "project," or other
similar words, phrases or expressions. Such forward-looking
statements include, but are not limited to, statements about the
benefits of the KYTHERA acquisition, including future financial and
operating results, Allergan's or KYTHERA's plans, objectives,
expectations and intentions and the expected timing of completion
of the transaction. It is important to note that Allergan's goals
and expectations are not predictions of actual performance. Actual
results may differ materially from Allergan's current expectations
depending upon a number of factors affecting Allergan's business,
KYTHERA's business and risks associated with acquisition
transactions. These factors include, among others, the inherent
uncertainty associated with financial projections; successful
closing of the KYTHERA acquisition; subsequent integration of the
KYTHERA acquisition and the market potential of KYBELLA™; the
ability to obtain required regulatory approvals for the transaction
and the timing of obtaining such approvals; the ability to obtain
the requisite KYTHERA stockholder approval; the risk that a
condition to closing of the KYTHERA acquisition may not be
satisfied on a timely basis or at all; the failure of the proposed
transaction to close for any other reason; risks relating to the
potential dilutive effect of the Allergan shares to be issued in
the transaction; the anticipated size of the markets and continued
demand for Allergan's and KYTHERA's products; the impact of
competitive products and pricing; access to available financing
(including financing for the acquisition or refinancing of debt) on
a timely basis and on reasonable terms; the risks of fluctuations
in foreign currency exchange rates; the risks and uncertainties
normally incident to the pharmaceutical industry, including product
liability claims and the availability of product liability
insurance on reasonable terms; the difficulty of predicting the
timing or outcome of pending or future litigation or government
investigations; periodic dependence on a small number of products
for a material source of net revenue or income; variability of
trade buying patterns; changes in generally accepted accounting
principles; risks that the carrying values of assets may be
negatively impacted by future events and circumstances; the timing
and success of product launches; the difficulty of predicting the
timing or outcome of product development efforts and regulatory
agency approvals or actions, if any; market acceptance of and
continued demand for Allergan's and KYTHERA's products; costs and
efforts to defend or enforce intellectual property rights;
difficulties or delays in manufacturing; the availability and
pricing of third party sourced products and materials; successful
compliance with governmental regulations applicable to Allergan's
and KYTHERA's facilities, products and/or businesses; changes in
the laws and regulations affecting, among other things, pricing and
reimbursement of pharmaceutical products; changes in tax laws or
interpretations that could increase Allergan's consolidated tax
liabilities; the loss of key senior management or scientific staff;
and such other risks and uncertainties detailed in Allergan's
periodic public filings with the Securities and Exchange Commission
(the "SEC"), including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2014, Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2015 (such periodic
public filings having been filed under the "Actavis plc" name), 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 or revise these forward-looking
statements.
KYTHERA Cautionary Statement Regarding Forward-Looking
Statements
This communication contains "forward-looking statements"
relating to the acquisition of KYTHERA by Allergan. Such
forward-looking statements are based on current expectations and
involve inherent risks and uncertainties, including factors that
could delay, divert or change any of them, and could cause actual
outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among
other risks, there can be no guarantee that the transaction will be
completed, or if it is completed, that it will close within the
anticipated time period. Forward-looking statements in the press
release should be evaluated together with the many uncertainties
that affect Allergan's business, particularly those identified in
the cautionary factors discussion in Allergan's periodic public
filings with the SEC, including but not limited to its Annual
Report on Form 10-K for the year ended December 31, 2014 and Quarterly Report on Form
10-Q for the quarterly period ended March
31, 2015 (such periodic public filings having been filed
under the "Actavis plc" name).
Except for the historical information presented herein, matters
discussed herein may constitute forward-looking statements that are
subject to certain risks and uncertainties that could cause actual
results to differ materially from any future results, performance
or achievements expressed or implied by such statements. Statements
that are not historical facts, including statements preceded by,
followed by, or that include the words "future"; "anticipate";
"potential"; "believe"; or similar statements are forward-looking
statements. Risks and uncertainties include uncertainties as to the
timing of the Merger; the possibility that various closing
conditions for the transaction may not be satisfied or waived,
including that a governmental entity may prohibit, delay or refuse
to grant approval for the consummation of the transaction; the
effects of disruption from the transaction making it more difficult
to maintain relationships with employees, licensees, other business
partners or governmental entities; the ability of KYBELLA™ to be a
first-in-class submental contouring injectable drug; anticipated
commercial availability of KYBELLA™; the ability of KYBELLA™ to be
a less-invasive, non-surgical option for the treatment of submental
fullness; expectations regarding KYTHERA's longer-term strategy; as
well as risks detailed from time to time in KYTHERA's periodic
public filings with the SEC, including, but not limited to, its
Annual Report on Form 10-K for the year ended December 31, 2014 and Quarterly Report on Form
10-Q for the quarterly period ended March
31, 2015. Such forward-looking statements involve
substantial risks and uncertainties that could cause KYTHERA's
clinical development programs, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the clinical drug development process, including the regulatory
approval process, KYTHERA's substantial dependence on KYBELLA™, and
other matters that could affect the availability or commercial
potential of KYTHERA's drug candidate. The forward-looking
statements made herein speak only as of the date hereof. KYTHERA
undertakes no obligation to update or revise any forward-looking
statements.
Important Information for Investors and
Shareholders
This communication does not constitute an offer to sell or the
solicitation of an offer to buy any securities or a solicitation of
any vote or approval, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. In connection with the
proposed acquisition by Allergan of KYTHERA, Allergan has filed
with the SEC a registration statement on Form S-4 that includes a
preliminary proxy statement of KYTHERA that also constitutes a
preliminary prospectus of Allergan. The registration statement is
not complete and will be further amended. The definitive proxy
statement/prospectus will be delivered to stockholders of KYTHERA.
INVESTORS AND SECURITY HOLDERS OF KYTHERA ARE URGED TO READ THE
PRELIMINARY PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT
HAVE BEEN FILED OR WILL BE FILED WITH THE SEC CAREFULLY AND IN
THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR
WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders
are able to obtain free copies of the registration statement and
the preliminary proxy statement/prospectus and other documents
filed with the SEC by Allergan and KYTHERA through the website
maintained by the SEC at http://www.sec.gov. Copies of the
documents filed with the SEC by Allergan are available free of
charge on Allergan's internet website at http://www.allergan.com or
by contacting Allergan's Investor Relations Department at (862)
261-7488. Copies of the documents filed with the SEC by KYTHERA are
available free of charge on KYTHERA's internet website at
http://www.kythera.com or by contacting KYTHERA's Investor
Relations Department at (818) 587-4559.
Participants in the Merger Solicitation
Allergan, KYTHERA, their respective directors and certain of
their executive officers and employees may be considered
participants in the solicitation of proxies in connection with the
proposed transaction. Information regarding the persons who may,
under the rules of the SEC, be deemed participants in the
solicitation of the KYTHERA stockholders in connection with the
proposed merger is set forth in the preliminary proxy
statement/prospectus and will be set forth in the definitive proxy
statement/prospectus when it is filed with the SEC. Information
about the directors and executive officers of KYTHERA is set forth
in its proxy statement for its 2015 annual meeting of stockholders,
which was filed with the SEC on April 23,
2015 and certain of its Current Reports on Form 8-K.
Information about the directors and executive officers of Allergan
is set forth in Allergan's proxy statement for its 2015 annual
meeting of shareholders, which was filed with the SEC on
April 24, 2015 and certain of its
Current Reports on Form 8-K (such proxy statement and certain of
such periodic public filings having been filed under the "Actavis
plc" name). Additional information regarding the participants in
the proxy solicitations and a description of their direct and
indirect interests, by security holdings or otherwise, are
contained in the preliminary proxy statement/prospectus filed with
the above-referenced registration statement on Form S-4 and will be
contained in the definitive proxy statement/prospectus and other
relevant materials to be filed with the SEC when they become
available.
CONTACTS:
Allergan:
Investors:
Lisa
DeFrancesco
(862) 261-7152
Media:
David Belian
(862) 261-8141
KYTHERA:
Investors:
Heather Rowe
(818) 587-4559
Media:
Ashley Cadle
(310) 463-0143
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SOURCE Allergan plc