ALLEGAN, Mich., April 21 /PRNewswire-FirstCall/ .- Perrigo Company today announced that it has filed an Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream, 2% and Suppository, 1.2g, a generic version of Monistat(R) 1 Combination Pack. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against Monistat 1.
Monistat 1 Combination Pack (miconazole nitrate vaginal cream, 2% and suppository, 1.2g) is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc.
Perrigo filed its ANDA for Miconazole Nitrate Vaginal Cream, 2% and Suppository 1.2g containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified Johnson & Johnson, the New Drug Application holder for Monistat 1 Combination Pack, and McNeil-PPC, Inc., the listed patent owner, of its filing. On April 18, 2008, McNeil filed suit alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates 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 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 30, 2007, 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.
CONTACT: Arthur J. Shannon, Vice President, Investor Relations and
Communication, +1-269-686-1709, ajshannon@perrigo.com; or Ernest J. Schenk,
Manager, Investor Relations and Communication, +1-269-673-9212,
eschenk@perrigo.com, both of Perrigo Company
Web site: http://www.perrigo.com/
