`
`Allergan Introduces RESTASIS
`MULTIDOSE™ (Cyclosporine
`Ophthalmic Emulsion) 0.05%, a New
`Delivery System for the One and Only
`FDA Approved Treatment to Help
`Patients Produce More of Their Own
`Tears
`RESTASIS® has Been Prescribed for 6.4 Million Patients Since its Launch
`and is Now Available in a Preservative Free, Multi-Dose Bottle
`
`NEWS PROVIDED BY
`Allergan plc
`○
`28 Oct, 2016, 09:47 ET
`
`DUBLIN, Oct. 28, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN) announced today
`that it has received approval from the U.S. Food and Drug Administration (FDA) for
`RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05%, a
`preservative-free, multi-dose bottle offering the same preservative-free formulation
`
`http://www.prnewswire.com/news-releases/allergan-introduces-restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-new-delivery-system-for-the-one-and-only-fda-app...
`
`MYLAN - EXHIBIT 1066
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`
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`Page 2 of 6
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`of RESTASIS since the launch in 2003. RESTASIS® is the one and only prescription
`treatment FDA approved to help patients with a type of Chronic Dry Eye make
`more of their own tears.
`
`Logo - http://photos.prnewswire.com/prnh/20150612/222796LOGO
`
`RESTASIS® helps increase your eyes' natural ability to produce tears, which may be
`reduced by inflammation due to Chronic Dry Eye. RESTASIS® did not increase tear
`production in patients using anti-inflammatory eye drops or tear duct plugs.
`
`"RESTASIS MULTIDOSE™ will be an important addition to the Allergan family of
`dry eye products, as it will enable healthcare providers to offer an additional option
`for those patients who may prefer their eye drops in a multi-dose bottle versus
`single-use vials," said Neda Shamie, MD, fellowship-trained cornea and cataract
`specialist, of Advanced Vision Care, of Los Angeles, Calif.
`
`RESTASIS MULTIDOSE™ is designed with a patented unidirectional valve and air
`filter technology that eliminates the need for a preservative. The new multi-dose
`bottle uses less plastic than a package of single-use vials and will be available for
`the same price.
`
`"RESTASIS MULTIDOSE™ exemplifies Allergan's commitment to innovation and
`customer responsiveness," said David Nicholson, Chief R&D Officer at Allergan.
`"Through our Open Science model, we drive to deliver advancements in highly
`engineered developments, such as the new multi-dose bottle."
`
`About Chronic Dry Eye
`
`http://www.prnewswire.com/news-releases/allergan-introduces-restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-new-delivery-system-for-the-one-and-only-fda-app...
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`Page 3 of 6
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`One type of chronic dry eye is caused by reduced tear production due to
`inflammation. Dry eye is often a chronic disease that can be caused by advanced
`age, contact lens wear, certain medications, eye diseases, other medical conditions
`or environmental factors. Without enough tears, the film protecting the eye can
`break down, creating dry spots on the cornea.
`
`About RESTASIS
`
`RESTASIS® and RESTASIS MULTIDOSE Ophthalmic Emulsion help increase your
`TM
`eyes' natural ability to produce tears, which may be reduced by inflammation due
`to Chronic Dry Eye. RESTASIS® and RESTASIS MULTIDOSE did not increase tear
`TM
`production in patients using anti-inflammatory eye drops or tear duct plugs.
`
`Important Safety Information
`Do not use RESTASIS® and RESTASIS MULTIDOSE Ophthalmic Emulsion if you
`TM
`are allergic to any of the ingredients. Be careful not to touch the container tip to
`your eye or other surfaces, to help avoid eye injury and contamination. RESTASIS®
`and RESTASIS MULTIDOSE should not be used while wearing contact lenses. If
`TM
`contact lenses are worn, they should be removed prior to use of RESTASIS® and
`RESTASIS MULTIDOSE and may be reinserted after 15 minutes.
`TM
`
`The most common side effect is a temporary burning sensation. Other side effects
`include eye redness, discharge, watery eyes, eye pain, foreign body sensation,
`itching, stinging, and blurred vision.
`
`You are encouraged to report negative side effects of prescription drugs to the
`FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
`
`Please click here http://www.allergan.com/assets/pdf/restasis-multidose_pi
`
`http://www.prnewswire.com/news-releases/allergan-introduces-restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-new-delivery-system-for-the-one-and-only-fda-app...
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`Page 4 of 6
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`About Allergan plc
`
`Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
`pharmaceutical company and a leader in a new industry model – Growth Pharma.
`Allergan is focused on developing, manufacturing and commercializing branded
`pharmaceuticals, devices and biologic products for patients around the world.
`
`Allergan markets a portfolio of leading brands and best-in-class products for the
`central nervous system, eye care, medical aesthetics and dermatology,
`gastroenterology, women's health, urology and anti-infective therapeutic
`categories.
`
`Allergan is an industry leader in Open Science, the Company's R&D model, which
`defines our approach to identifying and developing game-changing ideas and
`innovation for better patient care. This approach has led to Allergan building one
`of the broadest development pipelines in the pharmaceutical industry with 70+
`mid-to-late stage pipeline programs in development.
`
`Our Company's success is powered by our more than 16,000 global colleagues'
`commitment to being Bold for Life. Together, we build bridges, power ideas, act
`fast and drive results for our customers and patients around the world by always
`doing what is right.
`
`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 every day.
`
`For more information, visit Allergan's website at www.Allergan.com.
`
`http://www.prnewswire.com/news-releases/allergan-introduces-restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-new-delivery-system-for-the-one-and-only-fda-app...
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`Page 5 of 6
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`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 June 30, 2016 (certain of 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.
`
`CONTACTS:
`Investors:
`Lisa DeFrancesco
`(862) 261-7152
`
`Media:
`Mark Marmur
`(973) 906-1526
`
`Fran DeSena
`(973) 517-3132
`
`http://www.prnewswire.com/news-releases/allergan-introduces-restasis-multidose-cyclosporine-ophthalmic-emulsion-005-a-new-delivery-system-for-the-one-and-only-fda-app...
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`Page 6 of 6
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`SOURCE Allergan plc
`
`Related Links
`http://www.allergan.com
`
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