ALLEGAN, Mich., Sept. 8 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) announced today that it has acquired the exclusive
U.S. rights to sell and distribute Levocetirizine tablets, the generic
version of UCB's Xyzal(R) tablets, from Synthon Pharmaceuticals, Inc.
Synthon believes it has a first to file ANDA application for the generic
that can entitle it to 180 days of generic exclusivity upon approval.
Synthon and UCB are currently engaged in Paragraph IV/Hatch-Waxman
litigation over the Synthon ANDA filing.
Xyzal(R) is indicated for the treatment of indoor and outdoor
allergies. It is estimated that it has annual sales of approximately $200
million dollars growing at 15% per year, according to data provided by
Wolters, Kluwer.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is a prime
example of Perrigo's strategic focus on introducing new products which will
make quality healthcare more affordable to American consumers. Given
Perrigo's unique model of leadership in both the over-the-counter and
generic prescription businesses, we can leverage this first to file
opportunity whether the brand product stays behind the pharmacy counter or
if it switches to an over-the-counter status, a likely scenario."
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 ).
Synthon Pharmaceuticals, Inc., with its U.S. headquarters and
laboratories located in Research Triangle Park, North Carolina, markets
generic drugs under its own name and through partnerships with other
leading pharmaceutical companies. Synthon currently holds several approved,
or tentatively approved, drug applications and our pipeline contains more
than a dozen products that are expected to be filed with the FDA within the
next few years. Synthon Pharmaceuticals, Inc. is part of the Synthon group,
a global privately held specialty pharma company with offices, laboratories
and manufacturing sites in the Netherlands, Spain, Czech Republic,
Australia, Argentina, Chile and the USA. Visit Synthon on the Internet (
http://www.synthon.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
 back to top
Related links:
http://www.perrigo.com
http://www.synthon.com
CONTACT:
Arthur J. Shannon, Vice President, Investor
Relations and Communication, Perrigo Company, +1-269-686-1709,
ajshannon@perrigo.com
|
