ALLEGAN, Mich., April 5 Perrigo Company (Nasdaq: PRGO; TASE) today announced that together with its partner Cobrek Pharmaceuticals, Inc. final approval has been received from the U.S. Food and Drug Administration to manufacture and market Clindamycin Phosphate Foam 1%, a generic version of EvoclinŽ Foam 1% of Stiefel. As the ANDA was first to file with a Paragraph IV certification against EvoclinŽ, 180 days of generic exclusivity was granted by the U.S. Food and Drug Administration. Perrigo commenced shipping of the product immediately following Food and Drug Administration approval on March 31, 2010. In addition, Perrigo and Cobrek have reached an agreement to settle the underlying Hatch Waxman litigation brought by Stiefel Laboratories, a GSK Company. In accordance with the terms of the settlement Perrigo and Cobrek could continue to ship product until April 2, 2010. In addition, Perrigo can recommence shipments of the product on or after October 1, 2010. The agreement with Stiefel includes payments from Perrigo to Stiefel of license fees as well as royalties.
EvoclinŽ (clindamycin phosphate) Foam 1% is a topical antibiotic indicated for topical application in the treatment of acne vulgaris, and had sales of approximately $44 million for the 12 months ended February 2010, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This launch reflects our continuing investment in new products. It is an example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business. Perrigo will manufacture, sell and market Clindamycin exclusively in the U.S. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
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, Australia, 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.
SOURCE Perrigo Company