MILAN, ITALY -- (Marketwire) -- 07/20/09 -- 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 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. and Europe.