ALLEGAN, Mich., Nov. 1 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) announced today that Dexcel Pharma Technologies, Ltd.
("Dexcel"), Perrigo's partner for store brand OTC 20mg Omeprazole delayed
release tablet, has settled its patent litigation with AstraZeneca (the
manufacturer of Prilosec OTC(R)) involving three Orange Book patents ('380,
'230 and '505) relating to the product. While terms and conditions of the
agreement have not been disclosed, the amicable settlement and dismissal
with prejudice of the litigation will allow for commercialization of the
product once Dexcel receives final regulatory approval from the U.S. Food &
Drug Administration. Based upon Dexcel's estimated FDA approval date,
Perrigo should be in a position to launch the product by the end of first
quarter calendar year 2008.
Dexcel had filed its New Drug Application (NDA) with a Paragraph IV
Certification stating that AstraZeneca's patents are invalid,
unenforceable, or will not be infringed under the NDA. In May 2006,
AstraZeneca filed a patent infringement suit to prevent Dexcel from
commercialization of its product. The settlement between Dexcel and
AstraZeneca resolves this litigation with AstraZeneca waiving forever its
claims regarding the three Orange Book patents relating to Dexcel's
product.
Under terms of an agreement between Dexcel and Perrigo, Perrigo will be
the exclusive marketer and distributor for the store brand over-the-counter
market in the United States of the Dexcel-developed and manufactured
product. Perrigo expects full year annual sales for the product to be in
the range of $150 - $200 million. Perrigo will provide more detailed
information on the financial impact to fiscal year 2008 following Dexcel's
receipt of final FDA approval.
Prilosec OTC(R) is indicated for the treatment of frequent heartburn
and had estimated 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 Perrigo Company
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Related links:
http://www.perrigo.com/
CONTACT:
Arthur J. Shannon, Vice President of Investor
Relations and Communication, +1-269-686-1709,
ajshannon@perrigo.com, or Ernest J. Schenk, Manager of Investor
Relations and Communication, +1-269-673-9212,
eschenk@perrigo.com, both of Perrigo Company
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