ALLEGAN, Mich., June 29 Perrigo (Nasdaq: PRGO; TASE) today announced that it has acquired the exclusive U.S. store brand rights to sell and distribute OTC versions of Fexofenadine HCl 180 mg and 60 mg tabs, plus Fexofenadine HCl 60 mg and Pseudoephedrine 120 mg tabs, the generic versions of Sanofi-Aventis' Allegra and Allegra D-12 products. Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) currently has Rx approval for these products, and Teva and Sanofi-Aventis have settled their Paragraph IV/Hatch-Waxman litigation.
Allegra 180 mg, 60 mg, and Allegra D-12 are indicated for the relief of symptoms associated with seasonal allergies. Sanofi-Aventis has applied to the FDA for the Rx-to-OTC switch of these drugs. Prior to generic competition entering the Fexofenadine Rx market in 2005, Allegra 180 mg and 60 mg had combined annual sales of approximately $1.5 billion, and in 2009, Allegra D-12 had annual sales of $600 million according to data provided by Wolters-Kluwer.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example of Perrigo's strategic focus on making quality healthcare more affordable to American consumers by introducing new Rx-to-OTC switch products."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, infant formula, 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 and logistics operations are the United States, Australia, 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 27, 2009, 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.