Perrigo Confirms Filing for Generic Version of Clobex Spray and Announcement of Lawsuit by Galderma and Dermalogix
ALLEGAN, Mich., Dec. 9 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has filed an Abbreviated New Drug Application for Clobetasol Propionate Topical Spray, 0.05%, a generic form of Clobex® Spray.
Clobex® (clobetasol propionate) spray is indicated for the treatment of moderate to severe plaque psoriasis, and has estimated brand sales at retail of approximately $55 million annually.
Perrigo filed its ANDA for Clobetasol Topical Spray, 0.05%, containing a Paragraph IV certification with the U.S. Food & Drug Administration and notified Galderma Laboratories LP, the New Drug Application holder for Clobex® Spray, and Dermalogix Partners, Inc., the owner of the patent in suit, of its filing. On December 4, 2009, Galderma filed suit alleging patent infringement in the United States District Court for the Northern District of Texas to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the process under the Hatch-Waxman Act.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and focus on the expansion of the breadth of products in our portfolio. 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, 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