Perrigo Announces that Dexcel's Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that Dexcel Pharma Technologies, Ltd. ("Dexcel"), Perrigo's partner for store brand OTC 20mg Omeprazole delayed release tablet, has settled its patent litigation with AstraZeneca (the manufacturer of Prilosec OTC®) involving three Orange Book patents ('380, '230 and '505) relating to the product. While terms and conditions of the agreement have not been disclosed, the amicable settlement and dismissal with prejudice of the litigation will allow for commercialization of the product once Dexcel receives final regulatory approval from the U.S. Food & Drug Administration. Based upon Dexcel's estimated FDA approval date, Perrigo should be in a position to launch the product by the end of first quarter calendar year 2008.
Dexcel had filed its New Drug Application (NDA) with a Paragraph IV Certification stating that AstraZeneca's patents are invalid, unenforceable, or will not be infringed under the NDA. In May 2006, AstraZeneca filed a patent infringement suit to prevent Dexcel from commercialization of its product. The settlement between Dexcel and AstraZeneca resolves this litigation with AstraZeneca waiving forever its claims regarding the three Orange Book patents relating to Dexcel's product.
Under terms of an agreement between Dexcel and Perrigo, Perrigo will be the exclusive marketer and distributor for the store brand over-the-counter market in the United States of the Dexcel-developed and manufactured product. Perrigo expects full year annual sales for the product to be in the range of $150 - $200 million. Perrigo will provide more detailed information on the financial impact to fiscal year 2008 following Dexcel's receipt of final FDA approval.
Prilosec OTC® is indicated for the treatment of frequent heartburn and had estimated annual sales of approximately $750 million in all outlets.
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.
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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