ALLEGAN, Mich., June 9 Perrigo Company(Nasdaq: PRGO; TASE) today announced that it has filed an Abbreviated New DrugApplication (ANDA) for Fluocinonide Cream 0.1%, a generic version of VANOS(R)Cream 0.1%. The Company believes that it is the first to file an ANDA with aParagraph IV certification against VANOS(R).
VANOS(R) (fluocinonide) Cream 0.1% is a corticosteroid (steroid hormone)approved to relieve the inflammation and itching caused by certain skinconditions that respond to treatment with corticosteroids in patients 12 yearsof age or older, and had sales of approximately $27 million for the 12 monthsended April 2008, as measured by Wolters Kluwer Health.
Perrigo filed its ANDA for Fluocinonide Cream, 0.1% containing a ParagraphIV Certification with the U.S. Food & Drug Administration and notified MedicisPharmaceutical Corporation, the listed patent holder of its filing. On June 6,2008, Medicis filed suit alleging patent infringement in the United StatesDistrict Court for the Western District of Michigan to prevent Perrigo fromproceeding with the commercialization of its product. This action formallyinitiates the patent process under the Hatch-Waxman Act.
Perrigo Company is a leading global healthcare supplier that develops,manufactures and distributes over-the-counter (OTC) and prescriptionpharmaceuticals, nutritional products, active pharmaceutical ingredients (API)and consumer products. The Company is the world's largest manufacturer of OTCpharmaceutical products for the store brand market. The Company's primarymarkets 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-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 30, 2007, 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