Court Issues Temporary Restraining Order
ALLEGAN, Mich., March 11 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) today announced that it has received final approval
from the U.S. Food and Drug Administration (FDA) for its Abbreviated New
Drug Application (ANDA) for Clobetasol Propionate Foam, 0.05%.
The product is a topical corticosteroid indicated for the treatment of
moderate to severe dermatosis of the scalp. Sales for the brand, Olux(R)
Foam, 0.05%, were approximately $85 million according to Wolters Kluwer
data for the 12 months ending January 2008. As the first filer, Perrigo
will be eligible for 180 days of generic marketing exclusivity once it
launches the product.
Perrigo's Chairman and CEO Joseph C. Papa stated, "We are obviously
excited about this approval. This approval reflects our on-going efforts to
make quality healthcare more affordable for our customers and drive value
for our shareholders."
In late 2005, Connetics Corporation, which sells the brand drug, filed
a patent infringement suit against Perrigo in the United States District
Court for the District of New Jersey following Perrigo's paragraph IV
patent certification in its ANDA stating that the Connetics' patent is
invalid, unenforceable, or will not be infringed by Perrigo's ANDA. In
response to a motion filed by Connetics last Thursday, the Court
temporarily restrained Perrigo, as of March 7, 2008, from manufacturing,
using, offering to sell, selling or importing into the United States its
product pending the outcome of a hearing on March 19, 2008. On that date,
the Court will hear arguments on Perrigo's pending Summary Judgment Motion
as well as Connetics' Motion for a Preliminary Injunction.
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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