ALLEGAN, Mich., Sept. 8 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) announced today that it has acquired the exclusive U.S. rights to sell and distribute Levocetirizine tablets, the generic version of UCB's Xyzal® tablets, from Synthon Pharmaceuticals, Inc. Synthon believes it has a first to file ANDA application for the generic that can entitle it to 180 days of generic exclusivity upon approval. Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman litigation over the Synthon ANDA filing.
Xyzal® is indicated for the treatment of indoor and outdoor allergies. It is estimated that it has annual sales of approximately $200 million dollars growing at 15% per year, according to data provided by Wolters, Kluwer.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is a prime example of Perrigo's strategic focus on introducing new products which will make quality healthcare more affordable to American consumers. Given Perrigo's unique model of leadership in both the over-the-counter and generic prescription businesses, we can leverage this first to file opportunity whether the brand product stays behind the pharmacy counter or if it switches to an over-the-counter status, a likely scenario."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, 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 facilities are the United States, Israel, Mexico and the United Kingdom. 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 under its own name and through partnerships with other leading pharmaceutical companies. Synthon currently holds several approved, or tentatively approved, drug applications and our pipeline contains 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 the Netherlands, Spain, Czech Republic, Australia, Argentina, Chile and the USA. Visit Synthon on the Internet ( http://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 28, 2008, 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.
Source: Perrigo Company