Perrigo Company Announces Participation In Dexcel Pharma's Filing For Generic Version Of Prilosec OTC(R)
Published: Jun 07, 2006
ALLEGAN, Mich., June 7 /PRNewswire-FirstCall/ -- The Perrigo Company (Nasdaq: PRGO; TASE) announces its association with Dexcel Pharma Technologies, Ltd.'s new drug application for a generic version of Prilosec OTC®. Under the terms of an agreement between the two companies, Perrigo Company will be the exclusive marketer and distributor of the Dexcel Pharma Technologies, Ltd. developed and produced product for the store brand over- the-counter (OTC) market in the United States and will share in the costs and potential benefits associated with the commercialization of this product.
Prilosec OTC (omeprazole delayed-release tablets 20 mg) Acid Reducer is indicated for the treatment of frequent heartburn and had annual sales of approximately $500 million through food, drug and mass merchandisers for the twelve months ended April 16, 2006, based upon sales data as measured by Information Resources, Inc. and ACNielsen.
Dexcel Pharma Technologies, Ltd. filed its New Drug Application (NDA) for Omeprazole 20 mg tablets with the U.S. Food & Drug Administration (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. This action formally initiates the patent challenge process under the Hatch- Waxman Act.
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 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, 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 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. Please see the "Cautionary Note Regarding Forward-Looking Statements" on pages 33 - 41 of the Company's Form 10-K for the year ended June 25, 2005, as well as the Company's subsequent filings with the Securities and Exchange Commission, for a discussion of certain important factors that relate to forward-looking statements contained in this press release. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. 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