Perrigo Confirms Filing for Generic Version of Mucinex® and Announcement of Lawsuit by Adams Respiratory
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it had filed an Abbreviated New Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg, a generic version of Mucinex®.
Mucinex (guaifenesin extended-release tablets, 600 mg), an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $120 million through food, drug and mass merchandisers for the 12 months ended August 2007, as measured by Information Resources, Inc. and ACNielsen.
Perrigo filed its ANDA for Guaifenesin Extended-Release Tablets, 600 mg containing a Paragraph IV Certification with the U.S. Food & Drug Administration. Subsequently, Perrigo notified Adams Respiratory Therapeutics, Inc., the New Drug Application holder and patent owner for Mucinex of its filing. Today, Adams announced it filed suit alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act.
Perrigo's President and CEO Joseph C. Papa concluded, "This filing reflects our continuing investment in new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
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 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 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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