ALLEGAN, Mich., Sept. 18 /PRNewswire-FirstCall/ -- The Perrigo Company
(Nasdaq: PRGO; TASE) announced today that the Hatch-Waxman litigation
relating to Miconazole Nitrate Vaginal Cream and Suppository between
Johnson & Johnson and Perrigo has been dismissed. Earlier this year,
Perrigo had been sued by Johnson & Johnson's McNeil unit for infringement
of a patent related to Perrigo's filing of an ANDA for a generic to
Monistat(R) -1 Combination Pack in the United States District Court for the
District of New Jersey. Following FDA approval, Perrigo will begin
marketing its product under store brand and value brand labels to its
customers.
Perrigo's President and CEO Joseph C. Papa stated, "This is another
example of Perrigo's commitment to continue bringing new store brand
products to the market. The one-day Miconazole cream and suppository
introduction to the store brand market provides an important new product in
the feminine hygiene category to our retail and wholesale customers while
providing significant savings for the consumer. Perrigo is working every
day to make quality healthcare more affordable."
Monistat(R) -1 has annual retail sales of approximately $80 million
dollars. This OTC product is indicated for the treatment of vaginal yeast
infections and for the relief of external itching and irritation due to a
vaginal yeast infection. The dismissal of the lawsuit ends the 30 month
Hatch-Waxman stay period, which was originally set to expire in September
2010. Upon receiving final regulatory approval, Perrigo expects to launch
this product. The Company expects this launch to have 180 day first-to-file
exclusivity.
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 28, 2008, 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 of Perrigo Company, +1-269-686-1709,
ajshannon@perrigo.com
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