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`Perrigo and Synthon Announce FDA Final Approval and the Launch
`of the Generic Version of Xyzal®
`
`Nov 29, 2010
`
`ALLEGAN, Mich., Nov. 29, 2010 /PRNewswire-FirstCall/ -- Perrigo (Nasdaq: PRGO;TASE) today
`announced that its licensor and supplier Synthon has received final approval from the U.S. Food
`and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal® tablets
`from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis. Perrigo has the exclusive
`rights from Synthon to sell and distribute the product in the U.S. The Synthon product is the only
`approved generic product having a label containing all indications as the brand product and is
`entitled to 180 days of exclusivity for a product labeled for both allergy and hives. Product
`shipments commenced immediately upon FDA approval.
`
`Levocetirizine tablets (Xyzal®) are indicated for the treatment of indoor and outdoor allergies.
`According to Wolters Kluwer Health, sales for Xyzal Tablets for the 12 month period ending
`September 2010, were $224 million, a 12% increase over the previous 12 month period.
`
`Perrigo's Chairman and CEO Joseph C. Papa stated, "This is a terrific example of Perrigo
`leveraging its strong partnerships in bringing new products to market. We are excited to see the
`continued expansion of our generic Rx portfolio of products."
`
`Synthon's CEO Rudy Mareel commented, "Levocetirizine is one of several ANDAs for which
`Synthon has obtained 'First-Filer'-status with 180 days Hatch-Waxman marketing exclusivity. We
`are proud of this achievement and of our cooperation with Perrigo."
`
`Perrigo Company is a leading global healthcare supplier that develops, manufactures and
`distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional
`products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic
`products. The Company is the world's largest store brand manufacturer of OTC pharmaceutical
`products and infant formulas. The Company's primary markets and locations of manufacturing
`and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.
`Visit Perrigo on the Internet (http://www.perrigo.com).
`
`Synthon Pharmaceuticals, Inc., with its U.S. headquarters and laboratories located in Research
`Triangle Park, North Carolina, markets generic drugs through partnerships with other leading
`pharmaceutical companies. Synthon currently holds several approved, or tentatively approved,
`drug applications and has a pipeline containing more than a dozen products that are expected to
`be filed with the FDA within the next few years. Synthon Pharmaceuticals, Inc. is part of the
`Synthon group, a global privately held specialty pharma company with offices, laboratories and
`manufacturing sites in the Netherlands, Spain, Czech Republic, Australia, Argentina, Chile,
`Mexico, Russia and the USA. Visit Synthon on the Internet (http://www.synthon.com).
`
`Note: Certain statements in this press release are forward-looking statements within the meaning
`of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe
`harbor created thereby. These statements relate to future events or the Company's future
`financial performance and involve known and unknown risks, uncertainties and other factors that
`may cause the actual results, levels of activity, performance or achievements of the Company or
`its industry to be materially different from those expressed or implied by any forward-looking
`statements. In some cases, forward-looking statements can be identified by terminology such as
`"may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe,"
`"estimate," "predict," "potential" or other comparable terminology. The Company has based these
`forward-looking statements on its current expectations, assumptions, estimates and projections.
`While the Company believes these expectations, assumptions, estimates and projections are
`reasonable, such forward-looking statements are only predictions and involve known and
`unknown risks and uncertainties, many of which are beyond the Company's control. These and
`other important factors, including those discussed under "Risk Factors" in the Company's Form
`10-K for the year ended June 26, 2010, as well as the Company's subsequent filings with the
`Securities and Exchange Commission, may cause actual results, performance or achievements
`to differ materially from those expressed or implied by these forward-looking statements. The
`forward-looking statements in this press release are made only as of the date hereof, and unless
`otherwise required by applicable securities laws, the Company disclaims any intention or
`obligation to update or revise any forward-looking statements, whether as a result of new
`information, future events or otherwise.
`
`SOURCE Perrigo
`
`Exhibit 1104
`IPR2017-00807
`ARGENTUM
`http://perrigo.investorroom.com/2010-11-29-Perrigo-and-Synthon-Announce-FDA-Final-Approval-and-the-Launch-of-the-Generic-Version-of-Xyzal
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`Perrigo InvestorRoom - Press Releases
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`Quality Affordable Healthcare Products®
`
`Consumer Healthcare
`
`Core Values
`
`Perrigo Company plc, a leading global healthcare company,
`delivers value to its customers and consumers by providing
`Quality Affordable Healthcare Products®. Founded in 1887
`as a packager of home remedies, Perrigo has built a unique
`business model that is best described as the convergence of
`a fast-moving consumer goods company, a high-quality
`pharmaceutical manufacturing organization and a world-class
`supply chain network. Perrigo is the world's largest
`manufacturer of over-the-counter ("OTC") healthcare
`products and supplier of infant formulas for the store brand
`market. The Company also is a leading provider of branded
`OTC products throughout Europe and the U.S., as well as a
`leading producer of "extended topical" prescription drugs.
`Perrigo, headquartered in Ireland, sells its products primarily
`in North America and Europe, as well as in other markets,
`including Australia, Israel and China. Visit Perrigo online at
`(http://www.perrigo.com).
`
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