Healthcare Industry News: Sanofi-aventis
News Release - May 4, 2006
Perrigo Acknowledges Barr Patent Challenge of NASACORT(R) AQ Nasal SprayALLEGAN, Mich., May 4 (HSMN NewsFeed) -- Perrigo Company (Nasdaq: PRGO; TASE) today acknowledges its association with the patent challenge of NASACORT® AQ initiated by Barr Laboratories, Inc. a subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL ). Barr today announced that it is challenging the patents protecting Aventis Pharmaceuticals, Inc.'s NASACORT® AQ (Triamcinolone Acetonide) Nasal Spray. Barr developed its Triamcinolone Acetonide Nasal Spray product with Perrigo Company and under the terms of an agreement the parties will share in the costs and potential benefits. Barr believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for NASACORT AQ.
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 $346 million for the twelve months ended March 2006, based on IMS sales data.
Barr filed its ANDA for Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification with the U.S. Food & Drug Administration (FDA) in December 2005 and received notification of the application's acceptance for filing in March 2006. Following receipt of the notice from the FDA, Barr notified Aventis Pharmaceuticals, the New Drug Application (NDA) holder and patent owner. On May 2, 2006, Aventis filed suit in the U.S. District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
The Perrigo Company is a leading global healthcare supplier and the world's largest manufacturer of over-the-counter (OTC) pharmaceutical and nutritional products for the store brand market. Store brand products are sold by food, drug, mass merchandise, dollar store and club store retailers under their own labels. The Company also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products, and operates manufacturing facilities in the United States, Israel, United Kingdom, Mexico and Germany. 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. Please see the "Cautionary Note Regarding Forward-Looking Statements" on pages 33 - 41 of the Company's Form 10-K for the year ended June 25, 2005, as well as the Company's subsequent filings with the Securities and Exchange Commission, for a discussion of certain important factors that relate to forward-looking statements contained in this press release. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. 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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