ALLEGAN, Mich., June 9 MI-Perrigo-filesVANOS
ALLEGAN, Mich., June 9 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) today announced that it has filed an Abbreviated New Drug
Application (ANDA) for Fluocinonide Cream 0.1%, a generic version of VANOS(R)
Cream 0.1%. The Company believes that it is the first to file an ANDA with a
Paragraph IV certification against VANOS(R).
VANOS(R) (fluocinonide) Cream 0.1% is a corticosteroid (steroid hormone)
approved to relieve the inflammation and itching caused by certain skin
conditions that respond to treatment with corticosteroids in patients 12 years
of age or older, and had sales of approximately $27 million for the 12 months
ended April 2008, as measured by Wolters Kluwer Health.
Perrigo filed its ANDA for Fluocinonide Cream, 0.1% containing a Paragraph
IV Certification with the U.S. Food & Drug Administration and notified Medicis
Pharmaceutical Corporation, the listed patent holder of its filing. On June 6,
2008, Medicis filed suit alleging patent infringement in the United States
District Court for the Western District of Michigan 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
