Jul. 20, 2009 (Hugin AS) --
MILAN, ITALY--(Marketwire - July 20, 2009) - Eurand N.V. (NASDAQ:EURX) (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
successfully completed.
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 Gearóid 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 Lamictal® ODT(TM)(lamotrigine) Orally
Disintegrating Tablets. Like Paracetamol ODT, Lamictal ODT uses
Eurand's AdvaTab® orally disintegrating tablet (ODT) and Microcaps®
taste-masking technologies.
About Eurand
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.
