Perrigo Company (Nasdaq: PRGO; TASE) and its partner Synthon Pharmaceuticals, Inc. today announced that it has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Levocetirizine Solution, 2.5 mg/5ml, a generic version of UCB’s Xyzal® Oral Solution. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.
Xyzal® Oral Solution is indicated for the treatment of indoor and outdoor allergies. It is estimated that it has annual sales of approximately $15 million dollars growing at 15% per year, according to data provided by Wolters, Kluwer.
Perrigo’s Chairman and CEO Joseph C. Papa concluded, “This is another example of Perrigo’s commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers.”
Synthon’s CEO Rudy Mareel, commented, “Levocetirizine is a prime example of several ANDAs for which Synthon has obtained ‘First-Filer’-status with 180 days Hatch-Waxman marketing exclusivity. The tentative approval of Levocetirizine oral solution yet again is proof to Synthon’s achievements and our fruitful cooperation with Perrigo.”
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products and active pharmaceutical ingredients (API). The Company is the world’s largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The Company’s primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Synthon Pharmaceuticals, Inc., with its U.S. headquarters and laboratories located in Research Triangle Park, North Carolina, markets generic drugs through partnerships with other leading pharmaceutical companies. Synthon currently holds several approved, or tentatively approved, drug applications and has a pipeline containing more than a dozen products that are expected to be filed with the FDA within the next few years. Synthon Pharmaceuticals, Inc. is part of the Synthon group, a global privately held specialty pharma company with offices, laboratories and manufacturing sites in 11 countries worldwide. (www.synthon.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 26, 2010, 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.