Eurand Successfully Completes Registration Procedure for Paracetamol
ODT 250 and 500 mg in the European Union
MILAN, ITALY--(Marketwire - July 20, 2009) - Eurand N.V. (NASDAQ:
EURX), a specialty pharmaceutical company that develops enhanced
pharmaceutical and biopharmaceutical products based on its
proprietary pharmaceutical technologies, announced today that the
Dutch Medicines Evaluation Board (MEB) informed the Company that the
Decentralized Procedure (DCP) for registration of Paracetamol 250 and
500 mg Orodispersible Tablets (ODT) in several EU countries has been
In addition to The Netherlands, which acted as the reference member
state, the DCP involved the United Kingdom, Germany, France, Italy
and Spain. Formal approval is now expected from each country by the
end of 2009. Eurand is actively seeking a partner to market and
distribute Paracetamol ODT in these countries.
Paracetamol (also known as acetaminophen) is a widely used analgesic
(pain reliever) and antipyretic (fever reducer). Paracetamol ODT is
indicated for symptomatic treatment of mild-to-moderate pain and/or
fever. The 500 mg dose is indicated in adults and adolescents (over
12 years old) only, and the 250 mg dose is for use in children from
the age of four and adolescents only. The product may be taken with
or without liquid.
"We are pleased by the Dutch MEB's decision regarding our Paracetamol
ODT, and we look forward to receiving approval in the six individual
countries later this year," said GearÃ³id Faherty, Chairman and Chief
Executive Officer. "We believe our formulation will deliver this
well-recognized pain reliever in a more patient friendly manner,
particularly for those patients who have difficulty swallowing."
He noted that this is the second ODT formulation that Eurand has had
approved this year. In May 2009, the FDA approved EUR-1048, marketed
by GlaxoSmithKline as LamictalÂ® ODT(TM) (lamotrigine) Orally
Disintegrating Tablets. Like Paracetamol ODT, Lamictal ODT uses
Eurand's AdvaTabÂ® orally disintegrating tablet (ODT) and MicrocapsÂ®
Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary pharmaceutical
technologies. Eurand has had five products approved by the FDA since
2001 and has a pipeline of product candidates in development for
itself and its collaboration partners. Its technology platforms
include bioavailability enhancement of poorly soluble drugs, custom
release profiles, taste-masking orally disintegrating tablet (ODT)
formulations, and drug conjugation.
Eurand is a global company with facilities in the U.S. and Europe.
For more information, visit Eurand's website at www.eurand.com.
This release, and oral statements made with respect to information
contained in this release, constitutes forward-looking statements.
Such forward-looking statements include those which express plan,
anticipation, intent, contingency, goals, targets or future
development and/or otherwise are not statements of historical fact
including, but not limited to the future and status of our regulatory
filings, development plans and product development activities. The
words "potentially," "anticipates," "could," "calls for" and similar
expressions also identify forward-looking statements. These
statements are based upon management's current expectations and are
subject to risks and uncertainties, known and unknown, which could
cause actual results and developments to differ materially from those
expressed or implied in such statements. Factors that could affect
actual results include risks associated with the possibility that
regulatory agencies do not approve the registration of Paracetamol
ODT; unexpected delays or additional requirements. Forward-looking
statements contained in this press release are made as of this date,
and we undertake no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Actual events could differ materially from those
anticipated in the forward-looking statements.
LAMICTAL ODT is a trademark of the GlaxoSmithKline group of
Vice President, Investor Relations
Nick Laudico/Sara Pellegrino
The Ruth Group
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