PHILADELPHIA, Dec. 18, 2007 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that GlaxoSmithKline ("GSK") has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for an orally disintegrating tablet formulation of a product co-developed with Eurand using the Company's Microcaps(r) taste-masking and AdvaTab(r) technologies.
GSK successfully completed a bioequivalence study of the formulation in August 2007 and if approved, expects to launch the product in late 2008 in the US. Eurand is entitled to a milestone payment from GSK upon FDA acceptance for review of the NDA.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "We are pleased that GSK continues to steadily progress this product towards commercialization and look forward to the anticipated launch in 2008."
About Eurand
Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand has completed two phase III clinical trials on its lead product candidate, Zentase, for the treatment of Exocrine Pancreatic Insufficiency and filed a rolling NDA for this product which the company anticipates to complete by the end of 2007. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-masking/fast-dissolving formulations and drug conjugation.
Eurand is a global company with facilities in the USA 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 our plans for our NDA filing, enrollment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities, the benefits of the acquisition of SourceCF, the timing of and the expectation that the acquisition of SourceCF will be accretive to net income and our plans for SourceCF's product portfolio and personnel. The words "anticipates," "plans," "intends," "expects," "believes," "will" 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 the FDA refuses to approve our NDA; the outcome of any discussions with the FDA; unexpected delays in preparation of materials for submission to the FDA as a part of our NDA filing and our ability to successfully integrate the operations and personnel of SourceCF with our U.S. commercial organization. A more detailed list and description of the risks and uncertainties that the Company faces can be found under the heading "Risk factors" in the Company's Registration Statement on Form S-1 which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of the forward-looking statements contained in this press release may prove to be incorrect. 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.