ALLEGAN, Mich., Sept. 27 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) announced today that it had filed an Abbreviated New
Drug Application (ANDA) for Guaifenesin Extended-Release Tablets, 600 mg, a
generic version of Mucinex(R).
Mucinex (guaifenesin extended-release tablets, 600 mg), an expectorant
indicated to relieve chest congestion and make coughs more productive, had
sales of approximately $120 million through food, drug and mass
merchandisers for the 12 months ended August 2007, as measured by
Information Resources, Inc. and ACNielsen.
Perrigo filed its ANDA for Guaifenesin Extended-Release Tablets, 600 mg
containing a Paragraph IV Certification with the U.S. Food & Drug
Administration. Subsequently, Perrigo notified Adams Respiratory
Therapeutics, Inc., the New Drug Application holder and patent owner for
Mucinex of its filing. Today, Adams announced it filed suit alleging patent
infringement in the United States District Court for the District of New
Jersey to prevent Perrigo from proceeding with the commercialization of its
product. This action formally initiates the patent process under the
Hatch-Waxman Act.
Perrigo's President and CEO Joseph C. Papa concluded, "This filing
reflects our continuing investment in new products. As always, Perrigo is
committed to making quality healthcare more affordable for our customers
and drive value for our shareholders."
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, 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 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 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, both of Perrigo Company
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