Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has purchased the ANDA for clindamycin phosphate (1%) and benzoyl peroxide (5%) gel from KV Pharmaceutical for $14 million in cash at closing and a $2 million milestone payment upon the completion of a successful technical transfer. This product is the AB-rated equivalent to Stiefel Laboratories' (a subsidiary of Glaxo SmithKline) 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.
KV Pharmaceutical was the first to file its ANDA for clindamycin phosphate (1%) and benzoyl peroxide (5%) gel containing a Paragraph IV Certification with the U.S. Food & Drug Administration. After KV Pharmaceutical notified Stiefel Laboratories, the patent owner and New Drug Application holder for Duac gel of their filing, Stiefel filed suit in May 2009 in the United States District Court for the District of Delaware, alleging patent infringement against KV Pharmaceutical. Perrigo has assumed responsibility for this litigation. Subsequent to the acquisition, Perrigo will immediately begin working on the transfer of production to a Perrigo site with the intention to amend the ANDA accordingly.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This acquisition is another example of Perrigo's commitment to make the investments to build our product portfolio and deliver quality affordable healthcare products, as well as solidify our leadership position in the generic topical space."
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 28, 2008, 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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