DUBLIN, June 13, 2016 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO; TASE) announced that it has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for ingenol mebutate gel (0.015% and 0.05%), the generic versions of Picato® gel (0.015% and 0.05%). Perrigo has notified Leo Pharma A/S and Leo Laboratories, Ltd., the owners of the New Drug Applications (NDAs) and patents listed in FDA’s Orange Book, of its filings.
On June 10, 2016, Leo Pharma A/S, Leo Laboratories Limited and Leo Pharma, Inc. filed suit in the United States District Court for the District of Delaware alleging patent infringement. This action formally initiates the litigation process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, making it eligible for 180 days of generic exclusivity.
Picato® gel (ingenol mebutate gel) is a prescription medicine indicated for the topical treatment of actinic keratosis. Branded sales for the twelve months ending April 2016 were approximately $69 million.
Perrigo’s CEO John T. Hendrickson stated, “This filing illustrates Perrigo’s commitment to providing Quality Affordable Healthcare Products®. The Rx team continues to invest in the development of important products that strengthen our extended topicals portfolio and drive savings for our customers and consumers.”
About Perrigo
Perrigo Company plc, a top five global over-the-counter (“OTC”) consumer goods and pharmaceutical company, offers patients and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of generic home remedies, Perrigo, headquartered in Ireland, has grown to become the world’s largest manufacturer of OTC products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products and receives royalties from Multiple Sclerosis drug Tysabri®. Perrigo provides Quality Affordable Healthcare Products® across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other markets, including Israel, China and Latin America. Visit Perrigo online at (http://www.perrigo.com).
Forward-Looking Statements
Certain statements in this press release are “forward-looking statements.” 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 the negative of those terms 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, including the timing, amount and cost of share repurchases, future impairment charges, our ability to achieve our guidance and the ability to execute and achieve the desired benefits of announced initiatives. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-KT for the six-month period ended December 31, 2015, and form 10-Q for the quarter ended April 2, 2016 as well as the Company’s subsequent filings with the SEC, 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.
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SOURCE Perrigo Company plc
