The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the U.S. Food & Drug Administration (FDA) has granted tentative approval to Dexcel Pharma Technologies, Ltd. (Dexcel) for its new drug application (NDA) for 20 mg omeprazole delayed- release tablets. Once final approval has been granted by the FDA, Perrigo will be the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States.
The reference listed drug (Prilosec OTC®, Omeprazole delayed-release tablets, 20 mg, AstraZeneca) is subject to a period of patent protection. Dexcel filed its NDA with a paragraph IV patent certification stating that the patents are invalid, unenforceable, or will not be infringed under this NDA. On May 30, 2006, AstraZeneca filed a patent infringement suit in the U.S. District of Delaware to prevent Dexcel from proceeding with the commercialization of its product. 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 patents in suit expire, or are held invalid, unenforceable, or not infringed. Litigation is currently ongoing, with trial set for later this year.
Prilosec OTC® is indicated for the treatment of frequent heartburn and had annual sales of approximately $700 million through food, drug, and mass merchandisers, for the 12 months ended May 13, 2007, based upon sales data as measured by Information Resources, Inc. and AC Nielsen.
Headquartered in Or Akiva, Israel, Dexcel Pharma Technologies, Ltd. is a privately-held, international specialty pharmaceutical company which focuses on the development, manufacture and marketing of innovative prescription, generic prescription, and OTC products, based on its proprietary drug delivery systems.
The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter 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, the 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.
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