The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that its Perrigo Israel Pharmaceuticals subsidiary has been granted tentative approval from the U. S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%. The reference listed drug (Olux® Foam, 0.05%, Connetics Corporation) is subject to a period of patent protection. Perrigo filed its ANDA with a paragraph IV patent certification stating that the patent is invalid, unenforceable, or will not be infringed under this ANDA.
Final approval will not be granted until the expiration of the 30-month period provided under the Hatch-Waxman Act, unless, before that time, the patent expires or is judged to be invalid or not infringed. On October 19, 2005, Connetics filed suit in the U. S. District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. Litigation is currently ongoing.
If successful in the legal action, and upon final approval, Perrigo expects to be granted 180 days of generic marketing exclusivity. Sales for the brand were approximately $78 million, according to Wolters Kluwer data for the twelve months ending July 2006.
The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by food, drug, mass merchandise, dollar store and club store retailers under their own labels. The Company also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products, and operates manufacturing facilities in the United States, Israel, United Kingdom, Mexico, Germany and China. 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 particular, statements about the Company's expectations, beliefs, plans, objectives, assumptions or future events or performance contained in this press release are 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 the negative of those terms 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 July 1, 2006, 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
CONTACT: Arthur J. Shannon, Vice President, Investor Relations and
Communication, +1-269-686-1709, E-mail: ajshannon@perrigo.com , or Ernest J.
Schenk, Manager, Investor Relations and Communication, +1-269-673-9212,
E-mail: eschenk@perrigo.com , both of Perrigo Company
Web site: http://www.perrigo.com/