Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.
The product is a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand, Olux® Foam, 0.05%, were approximately $85 million according to Wolters Kluwer data for the 12 months ending January 2008. As the first filer, Perrigo will be eligible for 180 days of generic marketing exclusivity once it launches the product.
Perrigo's Chairman and CEO Joseph C. Papa stated, "We are obviously excited about this approval. This approval reflects our on-going efforts to make quality healthcare more affordable for our customers and drive value for our shareholders."
In late 2005, Connetics Corporation, which sells the brand drug, filed a patent infringement suit against Perrigo in the United States District Court for the District of New Jersey following Perrigo's paragraph IV patent certification in its ANDA stating that the Connetics' patent is invalid, unenforceable, or will not be infringed by Perrigo's ANDA. In response to a motion filed by Connetics last Thursday, the Court temporarily restrained Perrigo, as of March 7, 2008, from manufacturing, using, offering to sell, selling or importing into the United States its product pending the outcome of a hearing on March 19, 2008. On that date, the Court will hear arguments on Perrigo's pending Summary Judgment Motion as well as Connetics' Motion for a Preliminary Injunction.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and 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 facilities 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 30, 2007, 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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