Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that its partner Cobrek Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Clindamycin Phosphate Foam 1%, a generic version of Evoclin® Foam 1%. The Company believes that Cobrek is the first to file an ANDA with a Paragraph IV certification against Evoclin®.
Evoclin® (clindamycin phosphate) Foam 1% is a topical antibiotic indicated for topical application in the treatment of acne vulgaris, and had sales of approximately $44 million for the 12 months ended January 2009, as measured by Wolters Kluwer Health.
The ANDA for Clindamycin Phosphate Foam, 1%, which was filed prior to enactment of the Q1 Program Supplemental Funding Act of 2008 (the "Q1 Act"), was timely amended to contain a Paragraph IV Certification in accordance with the Q1 Act. On March 13, 2009, Stiefel filed suit alleging patent infringement in the United States District Court for the District of Delaware against Perrigo and its partner Cobrek. Stiefel also has filed a Citizen Petition with the U.S. Food and Drug Administration ("the FDA") seeking to have a 30 month stay of Cobrek's ANDA approval imposed. The FDA has not ruled, neither have the courts, regarding whether the Q1 Act entitles Stiefel to a 30 month stay.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This filing reflects our continuing investment in new products. We are the manufacturer and developer of this product as well as the exclusive sales and marketer. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic 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 and logistics operations 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 28, 2008, 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.
First Call Analyst:
FCMN Contact: pblain@perrigo.com
SOURCE: Perrigo Company
CONTACT: Arthur J. Shannon, Vice President, Investor Relations and
Communication, +1-269-686-1709, ajshannon@perrigo.com, or Daniel B. Willard,
Manager, Investor Relations and Communication +1-269-686-1597,
dbwillard@perrigo.com, both of Perrigo Company
Web Site: http://www.perrigo.com/