Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today acknowledges the settlement of patent litigation brought by Sanofi-Aventis (NYSE: SNY) against Barr Laboratories, Inc. a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL). The suit was brought in the U.S. District Court of Delaware 2006 based upon Barr's filing of an ANDA for Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification. Barr believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for NASACORT AQ. Barr developed its Triamcinolone Acetonide Nasal Spray product with Perrigo Company and the ANDA is awaiting final approval from FDA.
Under the terms of the settlement, Barr will be able to market the ANDA product under license from Sanofi-Aventis as early as June 15, 2011 if Barr's ANDA is approved by that date, or earlier in certain circumstances. In addition, even if Barr's ANDA is not approved, Barr will have a license to launch a generic version of NASACORT AQ, supplied by Sanofi-Aventis, on December 1, 2013, or earlier, in certain circumstances. Upon product launch, Barr would pay Sanofi-Aventis a royalty. Perrigo will share in the costs and benefits of the settlement agreement between Barr and Sanofi-Aventis and in Barr's marketing of the products under the agreement.
NASACORT AQ (Triamcinolone Acetonide) Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older. NASACORT AQ had annual sales of approximately $336 million for the twelve months ended September 2008, based on Wolters Kluwer Health sales data.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes 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/ ).
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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