ALLEGAN, Mich., April 21 /PRNewswire-FirstCall/ .- Perrigo Company
(Nasdaq: PRGO; TASE) today announced that it has filed an Abbreviated New
Drug Application (ANDA) for over-the-counter (OTC) Miconazole Nitrate
Vaginal Cream, 2% and Suppository, 1.2g, a generic version of Monistat(R) 1
Combination Pack. The Company believes that it is the first to file an ANDA
with a Paragraph IV certification against Monistat 1.
Monistat 1 Combination Pack (miconazole nitrate vaginal cream, 2% and
suppository, 1.2g) is an antifungal medication indicated for the treatment
of vaginal yeast infections, and had sales of approximately $50 million
through food, drug and mass merchandisers for the 12 months ended March
2008, as measured by Information Resources, Inc.
Perrigo filed its ANDA for Miconazole Nitrate Vaginal Cream, 2% and
Suppository 1.2g containing a Paragraph IV Certification with the U.S. Food
& Drug Administration and notified Johnson & Johnson, the New Drug
Application holder for Monistat 1 Combination Pack, and McNeil-PPC, Inc.,
the listed patent owner, of its filing. On April 18, 2008, McNeil 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 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, 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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