The Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has been granted tentative approval from the U.S. Food and Drug Administration (FDA) on its
Abbreviated New Drug Application (ANDA) for Ciclopirox Topical Solution, 8%
(Nail Lacquer). Final approval is subject to the expiration of the
applicable period of patent protection for the reference listed drug
(Penlac(R) Nail Lacquer, distributed by Dermik Laboratories, a division of
Sanofi Aventis Pharmaceuticals USA) as listed in the FDA's Orange Book. The
patent will expire on September 18, 2007.
Penlac(R) Nail Lacquer is indicated for the treatment of mild to
moderate fungal infections of the fingernails and toenails and had sales of
$125 million, according to Wolters Kluwer data for the twelve months ending
August 2006.
The Perrigo Company is a leading global healthcare supplier and the
world's largest manufacturer of over-the-counter (OTC) pharmaceutical and
nutritional products for the store brand market. Store brand products are
sold by food, drug, mass merchandise, dollar store and club store retailers
under their own labels. The Company also develops, manufactures and markets
prescription generic drugs, active pharmaceutical ingredients and consumer
products, and operates manufacturing facilities in the United States,
Israel, United Kingdom, Mexico, Germany and China. Visit Perrigo on the
Internet (perrigo).
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 particular, statements about the Company's expectations,
beliefs, plans, objectives, assumptions or future events or performance
contained in this press release are 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 the negative of
those terms 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 July 1, 2006, 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.
Perrigo Company
perrigo