The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polarcrilex lozenges, 2 mg and 4 mg.
The product will be marketed under store brand labels and is equivalent to GlaxoSmithKline's Commit® lozenges. The product is indicated as an aid to smoking cessation. Retail sales for Commit lozenges were approximately $100 million in calendar 2005. Perrigo was the first applicant to file a complete abbreviated new drug application (ANDA) with a Paragraph IV certification and has been granted 180 days of generic market exclusivity. First shipments are expected within 30 days.
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 and Germany. 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.
Commit® is a registered trademark of GlaxoSmithKline Consumer Healthcare, L.P.
SOURCE: Perrigo Company
CONTACT: Ernest J. Schenk, Manager, Investor Relations and Communication
of Perrigo Company, +1-269-673-9212, E-mail: firstname.lastname@example.org
Web site: http://www.perrigo.com/