Eurand Successfully Completes Registration Procedure for Paracetamol
ODT 250 and 500 mg in the Europ
Eurand Successfully Completes Registration Procedure for Paracetamol ODT 250 and 500 mg in the European Union
(Thomson Reuters ONE) - MILAN, ITALY--(Marketwire - July 20, 2009) - Eurand N.V. (NASDAQ:EURX), a specialty pharmaceutical company that develops enhancedpharmaceutical and biopharmaceutical products based on itsproprietary pharmaceutical technologies, announced today that theDutch Medicines Evaluation Board (MEB) informed the Company that theDecentralized Procedure (DCP) for registration of Paracetamol 250 and500 mg Orodispersible Tablets (ODT) in several EU countries has beensuccessfully completed.In addition to The Netherlands, which acted as the reference memberstate, the DCP involved the United Kingdom, Germany, France, Italyand Spain. Formal approval is now expected from each country by theend of 2009. Eurand is actively seeking a partner to market anddistribute Paracetamol ODT in these countries.Paracetamol (also known as acetaminophen) is a widely used analgesic(pain reliever) and antipyretic (fever reducer). Paracetamol ODT isindicated for symptomatic treatment of mild-to-moderate pain and/orfever. The 500 mg dose is indicated in adults and adolescents (over12 years old) only, and the 250 mg dose is for use in children fromthe age of four and adolescents only. The product may be taken withor without liquid."We are pleased by the Dutch MEB's decision regarding our ParacetamolODT, and we look forward to receiving approval in the six individualcountries later this year," said Gearóid Faherty, Chairman and ChiefExecutive Officer. "We believe our formulation will deliver thiswell-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 hadapproved this year. In May 2009, the FDA approved EUR-1048, marketedby GlaxoSmithKline as Lamictal® ODT(TM) (lamotrigine) OrallyDisintegrating Tablets. Like Paracetamol ODT, Lamictal ODT usesEurand's AdvaTab® orally disintegrating tablet (ODT) and Microcaps®taste-masking technologies.About EurandEurand is a specialty pharmaceutical company that develops,manufactures and commercializes enhanced pharmaceutical andbiopharmaceutical products based on its proprietary pharmaceuticaltechnologies. Eurand has had five products approved by the FDA since2001 and has a pipeline of product candidates in development foritself and its collaboration partners. Its technology platformsinclude bioavailability enhancement of poorly soluble drugs, customrelease 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.Forward-Looking StatementThis release, and oral statements made with respect to informationcontained in this release, constitutes forward-looking statements.Such forward-looking statements include those which express plan,anticipation, intent, contingency, goals, targets or futuredevelopment and/or otherwise are not statements of historical factincluding, but not limited to the future and status of our regulatoryfilings, development plans and product development activities. Thewords "potentially," "anticipates," "could," "calls for" and similarexpressions also identify forward-looking statements. Thesestatements are based upon management's current expectations and aresubject to risks and uncertainties, known and unknown, which couldcause actual results and developments to differ materially from thoseexpressed or implied in such statements. Factors that could affectactual results include risks associated with the possibility thatregulatory agencies do not approve the registration of ParacetamolODT; unexpected delays or additional requirements. Forward-lookingstatements contained in this press release are made as of this date,and we undertake no obligation to publicly update any forward-lookingstatement, whether as a result of new information, future events orotherwise. Actual events could differ materially from thoseanticipated in the forward-looking statements.LAMICTAL ODT is a trademark of the GlaxoSmithKline group ofcompanies.Contacts:Bill NewbouldVice President, Investor RelationsEurand N.V.+1 267-759-9335bill.newbould(at)eurand.comNick Laudico/Sara PellegrinoThe Ruth Group+1 646-536-7030/7002nlaudico(at)theruthgroup.comspellegrino(at)theruthgroup.comThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Bereitgestellt von Benutzer: hugin
" alt="'Pragmatic and Low-Risk' Organisations Will Drive Economic Recovery>">Datum: 20.07.2009 - 13:01 Uhr
Sprache: Deutsch
News-ID 3739
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 347 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Eurand Successfully Completes Registration Procedure for Paracetamol
ODT 250 and 500 mg in the Europ"
steht unter der journalistisch-redaktionellen Verantwortung von
Eurand N.V. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
