ALLEGAN, Mich., Mar. 6 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) today announced that its partner, Teva Pharmaceutical
Industries Ltd. (Nasdaq: TEVA), has received final approval from the U.S.
Food and Drug Administration (FDA) for its Abbreviated New Drug Application
(ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine
Hydrochloride Extended-Release Tablets, 5 mg/120 mg.
The product will be marketed by Perrigo under store brand labels and is
comparable to McNeil Consumer Healthcare's recently launched Zyrtec-D(R)
Extended-Release Tablets, indicated for 12 hour relief of indoor and
outdoor allergy symptoms and nasal congestion. According to Wolters Kluwer
data, brand sales for the original prescription strength version of the
product for the 12 months ending December 2007 were approximately $190
million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval and
marketing agreement reflect our strategy to be first to market with the
important products that make quality healthcare more affordable for our
customers and drive value for our shareholders."
The Company expects to begin shipping the product in the next 90 days.
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,
+1-269-686-1709, ajshannon@perrigo.com, or Ernest J. Schenk,
Manager, +1-269-673-9212, eschenk@perrigo.com, both of Investor
Relations and Communication, Perrigo Company
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