Published:
Perrigo Acquires Exclusive Sales and Distribution Rights to Allergy Drug Levocetirizine from Synthon
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 arethe United States,
Israel,Mexico and theUnited Kingdom. Visit Perrigo on the Internet
( http://www.perrigo.com ).
Synthon Pharmaceuticals, Inc., with its U.S. headquarters and laboratories
located inResearch 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
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