Perrigo Confirms Filing for Generic Version of Gynazole-1® Cream and Announcement of Patent Infringement Lawsuit by KV Pharma
ALLEGAN, Mich., July 30 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for butoconazole nitrate vaginal cream, 2% and that is has notified KV Pharmaceutical Company, the owner of the New Drug Application (NDA) as well as FemmePharma, the listed owner of the patent, of its ANDA filing. KV is a licensee under the patent. Perrigo believes it is first-to-file on this product.
On July 29, 2010, KV Pharmaceutical Company filed suit in the United States District Court for the District of Delaware, alleging patent infringement to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act. The suit also named FemmePharma as a defendant as it had not agreed to join KV as a plaintiff in the suit.
Gynazole·1® (butoconazole nitrate) vaginal cream, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections cause by Candida). Prior to its being discontinued in January 2009 due to manufacturing issues at KV, its annual sales were approximately $28 million annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and expansion of our product portfolio. The first to file status also reflects Perrigo's continued focus on being first to market with new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, nutritional products, and active pharmaceutical ingredients (API), and pharmaceutical and medical diagnostic 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 and logistics operations are the United States, Australia, 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 27, 2009, 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.
SOURCE Perrigo Company