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Perrigo Company (PRGO) Confirms Patent Challenge for Generic Version of Axiron® Topical Solution


5/29/2013 10:27:16 AM

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ALLEGAN, Mich., May 29, 2013 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for testosterone topical solution, the generic version of Axiron® Topical Solution.

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO )

Perrigo previously notified Eli Lilly, the owner of the New Drug Application and Acrux DDS PTY Ltd., owners of patents listed in FDA's Orange Book and Lilly and Acrux filed suit in the United States District Court for the Southern District of Indiana on May 24, 2013. To our knowledge Perrigo is the only company that has been sued at this time.

Axiron® topical solution (testosterone) is a prescription medicine used to treat adult males who have low or no testosterone. Axiron® is not intended for use in women or anyone under 18 years of age. Annual sales were approximately $229 million annually, as measured by Symphony Health Solutions.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our long-term investment in bringing new products to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers."

From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia. Visit Perrigo on the Internet (http://www.perrigo.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 30, 2012, 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 Company



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