Perrigo Confirms That its Partner Synthon Has Filed for Generic Version of Xyzal® Solution and Announcement of Lawsuit by Sepracor/UCB
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal® solution 2.5mg/5ml. Under terms of an exclusive agreement between the companies, Perrigo has sales and marketing rights in Synthon's Levocetirizine products. The Company believes that Synthon is the first to file an ANDA with a Paragraph IV certification against Xyzal® solution that can entitle it to 180 days of generic exclusivity upon approval.
Xyzal® solution (Levocetirizine solution) 2.5mg/5ml is indicated for relief of symptoms associated with allergies and treatment of hives, and has sales of approximately $10 million annually, as measured by Wolters Kluwer Health for the quarter ending April 2009.
Synthon filed its ANDA for Levocetirizine solution 2.5 mg/5ml containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified UCB Inc., the New Drug Application holder for Xyzal® solution and Sepracor Inc., the listed patent owner, of its filing. On June 17, 2009, Sepracor and UCB filed suit alleging patent infringement in the United States District Court for the Eastern District of North Carolina against Synthon.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and expansion of our product portfolio. The first to file status also reflects Perrigo's continued focus on being first to market with new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic 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 and logistics operations 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.
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