ALLEGAN, Mich., June 20 /PRNewswire-FirstCall/ -- The Perrigo Company
(Nasdaq: PRGO; TASE) announced today that the U.S. Food & Drug
Administration (FDA) has granted tentative approval to Dexcel Pharma
Technologies, Ltd. (Dexcel) for its new drug application (NDA) for 20 mg
omeprazole delayed- release tablets. Once final approval has been granted
by the FDA, Perrigo will be the exclusive marketer and distributor of this
product for the store brand over-the-counter (OTC) market in the United
States.
The reference listed drug (Prilosec OTC(R), Omeprazole delayed-release
tablets, 20 mg, AstraZeneca) is subject to a period of patent protection.
Dexcel filed its NDA with a paragraph IV patent certification stating that
the patents are invalid, unenforceable, or will not be infringed under this
NDA. On May 30, 2006, AstraZeneca filed a patent infringement suit in the
U.S. District of Delaware to prevent Dexcel from proceeding with the
commercialization of its product. Final approval will not be granted until
the expiration of the 30-month period provided under the Hatch-Waxman Act,
unless, before that time, the patents in suit expire, or are held invalid,
unenforceable, or not infringed. Litigation is currently ongoing, with
trial set for later this year.
Prilosec OTC(R) is indicated for the treatment of frequent heartburn
and had annual sales of approximately $700 million through food, drug, and
mass merchandisers, for the 12 months ended May 13, 2007, based upon sales
data as measured by Information Resources, Inc. and AC Nielsen.
Headquartered in Or Akiva, Israel, Dexcel Pharma Technologies, Ltd. is
a privately-held, international specialty pharmaceutical company which
focuses on the development, manufacture and marketing of innovative
prescription, generic prescription, and OTC products, based on its
proprietary drug delivery systems.
The Perrigo Company is a leading global healthcare supplier and the
world's largest manufacturer of over-the-counter 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, the United Kingdom, Mexico, Germany and China. 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 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.
SOURCE Perrigo Company
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Related links:
http://www.perrigo.com/
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
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