Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the Hatch-Waxman litigation relating to Duac® Gel (clindamycin phosphate (1%) and benzoyl peroxide (5%) gel) filed by the Stiefel Laboratories division of Glaxo SmithKline has been dismissed with prejudice. Earlier this year, KV Pharmaceuticals had been sued by Stiefel for infringement of a patent related to KV's filing of an Abbreviated New Drug Application (ANDA) for a generic to Duac® Gel in the United States District Court for the District of Delaware. In September 2009 Perrigo acquired all rights in the KV Pharmaceutical's ANDA.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's commitment to continue bringing new topical generic products to the market at the earliest possible entry date. Perrigo is working every day to make quality healthcare more affordable."
This product is the AB-rated equivalent to Stiefel Laboratories' Duac® gel, indicated for the topical treatment of inflammatory acne vulgaris. Annual sales for the brand were approximately $165 million according to Wolters Kluwer data. The dismissal of the lawsuit ends the 30 month Hatch-Waxman stay period, which was originally set to expire towards the end of 2011. Upon receiving final regulatory approval, Perrigo expects to launch this product. The Company expects this launch to have 180 day first-to-file exclusivity.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. 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 manufacturing and logistics operations are the United States, Israel, Mexico and the United Kingdom. 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 27, 2009, 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.
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