ALLEGAN, Mich., Dec. 10 /PRNewswire-FirstCall/ -- The Perrigo Company
(Nasdaq: PRGO; TASE) announced today that the U.S. Food & Drug
Administration (FDA) has granted final approval to Dexcel Pharma
Technologies, Ltd. for 20 mg Omeprazole delayed-release tablets. As the
exclusive marketer and distributor of this product for the store brand
over-the-counter (OTC) market in the United States, Perrigo expects to
begin shipping its product during the first quarter of calendar year 2008,
with full year annual sales to be in the range of $150 - $200 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "The approval from
the FDA is the final regulatory step for this exclusive product launch,
which we expect to be the largest product in Perrigo's 120 year history.
While we are excited about the opportunity, we will obviously continue
investing in research and development to add more new products to our
product offering. The launch of Omeprazole is another example of Perrigo's
dedication to make quality healthcare more affordable."
Based on pre-launch estimates, Perrigo's Omeprazole product is expected
to contribute between $0.20 and $0.25 earnings per share in fiscal year
2008. As a result of the Omeprazole launch, full year earnings for fiscal
year 2008 are expected to be in the range of $1.32 to $1.47 per share.
Prilosec OTC(R) is indicated for the treatment of frequent heartburn
and had estimated current annual sales of approximately $750 million in all
outlets.
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.
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.
SOURCE The 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, both of The Perrigo Company
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