Perrigo and Synthon Announce FDA Final Approval and the Launch of the Generic Version of Xyzal®
ALLEGAN, Mich., Nov. 29, 2010 /PRNewswire-FirstCall/ -- Perrigo (Nasdaq: PRGO;TASE) today announced that its licensor and supplier Synthon has received final approval from the U.S. Food and Drug Administration (FDA) for Levocetirizine tablets, a generic version of Xyzal® tablets from UCB/Sepracor, which is marketed in the U.S. by Sanofi-Aventis. Perrigo has the exclusive rights from Synthon to sell and distribute the product in the U.S. The Synthon product is the only approved generic product having a label containing all indications as the brand product and is entitled to 180 days of exclusivity for a product labeled for both allergy and hives. Product shipments commenced immediately upon FDA approval.
Levocetirizine tablets (Xyzal®) are indicated for the treatment of indoor and outdoor allergies. According to Wolters Kluwer Health, sales for Xyzal Tablets for the 12 month period ending September 2010, were $224 million, a 12% increase over the previous 12 month period.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is a terrific example of Perrigo leveraging its strong partnerships in bringing new products to market. We are excited to see the continued expansion of our generic Rx portfolio of products."
Synthon's CEO Rudy Mareel commented, "Levocetirizine is one of several ANDAs for which Synthon has obtained 'First-Filer'-status with 180 days Hatch-Waxman marketing exclusivity. We are proud of this achievement and of our 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, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products. 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 the Netherlands, Spain, Czech Republic, Australia, Argentina, Chile, Mexico, Russia 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 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.