ALLEGAN, Mich., June 11, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has agreed to settle its Hatch-Waxman litigation relating to Clobetasol propionate emulsion foam, 0.05% brought by Stiefel Research Australia Pty. Ltd., a GSK Company. Under the terms of the settlement, Perrigo can launch in the U.S., a generic version of Olux-E® (clobetasol propionate) Foam 0.05% on February 1, 2013, or earlier under certain circumstances. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity upon launch. Perrigo received tentative approval for this ANDA in October 2011 and this product was the result of a collaboration with Cobrek Pharmaceuticals.
Olux-E® Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older, and has annual sales of approximately $40 million, as measured by Wolters Kluwer.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This settlement further proves our commitment to launching new products to consumers. Perrigo continues its focus on bringing quality, affordable healthcare to the marketplace."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. 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).
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 25, 2011, 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