DUBLIN and SOUTH SAN FRANCISCO, Calif., July 6, 2015 /PRNewswire/ -- Allergan plc (NYSE:
AGN), a leading global pharmaceutical company, and Oculeve, a
development-stage medical device company focused on developing
novel treatments for dry eye disease, today announced that they
have entered into an agreement under which Allergan will acquire
Oculeve in an all-cash transaction. Under the terms of the
agreement, Allergan will acquire Oculeve for a $125 million upfront payment and
commercialization milestone payments related to Oculeve's lead
development program OD-01. The agreement also includes the
acquisition of an additional earlier-stage dry eye device
development program. Allergan's 2015 earnings-per-share forecast
provided on May 11, 2015 is unchanged
as a result of the acquisition. The Company remains committed to
de-levering to below 3.5x debt to Adjusted EBITDA by the end of the
first quarter of 2016.
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The acquisition of Oculeve adds novel, complementary dry eye
development programs to Allergan's current eye care research and
development programs, including OD-01, a non-invasive nasal
neurostimulation device that increases tear production in patients
with dry eye disease. Oculeve has completed four clinical studies
of OD-01 to date in more than 200 patients, showing positive safety
and efficacy of the device. Allergan plans to conduct two
additional pivotal trials prior to FDA submission, which is
expected in 2016 with potential commercial launch in 2017.
"Allergan is committed to developing a broad range of
innovations that help patients address dry eye," said David Nicholson, Executive Vice President,
Global Brands Research and Development at Allergan. "The OD-01
program has been shown to provide a strong safety and efficacy
profile, and if approved, would provide an exciting new treatment
option for patients that is complementary to our existing product
offerings in this important treatment area."
"Allergan's position and expertise in eye care will maximize the
development and potential commercialization of the OD-01
technology," said Michael Ackermann,
President and CEO of Oculeve. "I am extraordinarily appreciative
and proud of the Oculeve team that has worked so hard to develop
our exciting technology, and I am thrilled for us to partner with
the Allergan team on the continued development, potential approval
and availability of OD-01 to patients worldwide."
Chronic dry eye is a disease that can be caused by advanced age,
contact lens wear, certain medications, eye diseases, other medical
conditions or environmental factors. One type of chronic dry eye is
caused by decreased tear production due to inflammation. Without
enough tears, the film protecting the eye can break down, creating
dry spots on the cornea. Chronic dry eye is estimated to affect 25
million patients in the U.S.i
The transaction is subject to the expiration or termination of
the waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976. Pending approvals, Allergan
anticipates closing the transaction in the third quarter of
2015.
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.
About Oculeve
Oculeve, Inc. is a medical device
company located in South San Francisco,
CA, focused on new technologies for dry eye disease.
The company was founded out of a multi-disciplinary collaboration
with the Stanford Biodesign Center and Department of Ophthalmology
at Stanford University, spun-out by
Michael Ackermann, CEO, Jim Loudin, VP of Research and Development,
Professor Mark Blumenkranz, who
serves on the Oculeve Board of Directors, and Professor
Daniel Palanker, who serves on the
Scientific Advisory Board. The company is backed by investors
Kleiner Perkins Caufield and Byers
(who also seeded the company), New Enterprise Associates and
Versant Ventures, and is represented legally by Wilson, Sonsini,
Goodrich & Rosati, and Morrison Forester.
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; risks associated with
acquisitions, mergers and joint ventures; 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 March 31, 2015. Except as expressly required by
law, Allergan disclaims any intent or obligation to update these
forward-looking statements.
i Market Scope®, 2011 Report on the Global
Market for Dry Eye Products; 2011, 1-148.
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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David
Belian
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(862)
261-8141
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Mark
Marmur
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(862)
261-7558
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Oculeve:
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Media:
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media@oculeve.com
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(415)
580-6107
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SOURCE Allergan plc