ALLEGAN, Mich., Nov. 19 Perrigo Company(Nasdaq: PRGO; TASE) today acknowledges the settlement of patent litigationbrought by Sanofi-Aventis (NYSE: SNY) against Barr Laboratories, Inc. asubsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL). The suit was brought inthe U.S. District Court of Delaware 2006 based upon Barr's filing of an ANDAfor Triamcinolone Acetonide Nasal Spray containing a paragraph IVcertification. Barr believes that it is the first to file an Abbreviated NewDrug Application (ANDA) containing a paragraph IV certification for NASACORTAQ. Barr developed its Triamcinolone Acetonide Nasal Spray product withPerrigo Company and the ANDA is awaiting final approval from FDA.
Under the terms of the settlement, Barr will be able to market the ANDAproduct under license from Sanofi-Aventis as early as June 15, 2011 if Barr'sANDA is approved by that date, or earlier in certain circumstances. Inaddition, even if Barr's ANDA is not approved, Barr will have a license tolaunch a generic version of NASACORT AQ, supplied by Sanofi-Aventis, onDecember 1, 2013, or earlier, in certain circumstances. Upon product launch,Barr would pay Sanofi-Aventis a royalty. Perrigo will share in the costs andbenefits of the settlement agreement between Barr and Sanofi-Aventis and inBarr's marketing of the products under the agreement.
NASACORT AQ (Triamcinolone Acetonide) Nasal Spray is indicated for thetreatment of the nasal symptoms of seasonal and perennial allergic rhinitis inadults and children 6 years of age and older. NASACORT AQ had annual sales ofapproximately $336 million for the twelve months ended September 2008, basedon Wolters Kluwer Health sales data.
Perrigo Company is a leading global healthcare supplier that develops,manufactures and distributes OTC and prescription pharmaceuticals, nutritionalproducts, active pharmaceutical ingredients (API) and consumer products. TheCompany is the world's largest manufacturer of OTC pharmaceutical products forthe store brand market. The Company's primary markets and locations ofmanufacturing facilities are the United States, Israel, Mexico and the UnitedKingdom. Visit Perrigo on the Internet ( http://www.perrigo.com ).
Note: Certain statements in this press release are forward-lookingstatements within the meaning of Section 21E of the Securities Exchange Act of1934, as amended, and are subject to the safe harbor created thereby. Thesestatements relate to future events or the Company's future financialperformance and involve known and unknown risks, uncertainties and otherfactors that may cause the actual results, levels of activity, performance orachievements of the Company or its industry to be materially different fromthose 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 currentexpectations, assumptions, estimates and projections. While the Companybelieves these expectations, assumptions, estimates and projections arereasonable, such forward-looking statements are only predictions and involveknown and unknown risks and uncertainties, many of which are beyond theCompany's control. These and other important factors, including thosediscussed under "Risk Factors" in the Company's Form 10-K for the year endedJune 28, 2008, as well as the Company's subsequent filings with the Securitiesand Exchange Commission, may cause actual results, performance or achievementsto differ materially from those expressed or implied by these forward-lookingstatements. The forward-looking statements in this press release are madeonly as of the date hereof, and unless otherwise required by applicablesecurities laws, the Company disclaims any intention or obligation to updateor revise any forward-looking statements, whether as a result of newinformation, future events or otherwise.
SOURCE Perrigo Company