The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that the U. S. Food & Drug Administration (FDA) has issued an approvable letter for Dexcel Pharma Technologies, Ltd.'s New Drug Application (NDA) for 20 mg omeprazole delayed-release tablets. As previously disclosed, Perrigo will be Dexcel Pharma Technologies, Ltd.'s exclusive marketer and distributor of this product for the store brand over- the-counter (OTC) market in the United States once the product has been approved for marketing by FDA.
An approvable letter is one of several intermediate steps in the FDA review process of new products. Joseph Papa, Perrigo's President and CEO stated, "This is an important milestone on Dexcel's path to receive FDA approval for the marketing of 20 mg omeprazole delayed-release tablets. The approval and market introduction of a store brand OTC omeprazole product will mean that consumers will save many millions of dollars by having the choice of a lower cost 20 mg omeprazole delayed-release product available."
There is currently one FDA approved 20 mg omeprazole magnesium tablet on the OTC market, Prilosec OTC®. Prilosec OTC is indicated for the treatment of frequent heartburn and had annual sales of approximately $600 million through food, drug and mass merchandisers, for the twelve months ended November 26, 2006, based upon sales data as measured by Information Resources, Inc. and ACNielsen.
Dexcel Pharma Technologies, Ltd. filed its NDA for 20 mg omeprazole tablets with the U.S. FDA and notified AstraZeneca, the NDA holder and patent owner for Prilosec OTC, of its filing. On May 30, 2006, AstraZeneca filed suit alleging patent infringement in the U.S. District Court of Delaware and, on May 31, 2006, in the U.S. District Court for the Eastern District of Virginia, to prevent Dexcel Pharma Technologies, Ltd. from proceeding with the commercialization of its product. The litigation is still pending.
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 drugs based on its proprietary drug delivery systems, generic prescription and OTC pharmaceutical products.
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, 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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