Positive Bioequivalence Study Results Trigger Milestone Payment for Eurand
04/09/2007 14:35
PR Newswire
MILAN, Italy, September 4 /PRNewswire/ --
Eurand N.V. (Nasdaq: EURX), a global specialty pharmaceutical company,
announced today that GlaxoSmithKline (NYSE: GSK), working in collaboration
with Eurand Inc., successfully completed a pivotal bioequivalence study of an
undisclosed GSK compound. GSK will make a milestone payment of US$1.5 million
to Eurand in recognition of this milestone.
The new formulation, using Eurand's Microcaps(TM) and AdvaTab(R)
technologies, is designed to dissolve quickly in the mouth without leaving a
sour or bitter taste. Eurand could potentially receive milestone payments
from GSK totaling up to US$42 million for the development of this product.
GSK expects to file an NDA in the near future. Under the agreement, and upon
approval of the NDA, Eurand will manufacture the product for GSK and receive
royalty revenues.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "We are
delighted with the results of the biostudy and are looking forward to
GlaxoSmithKline submitting their NDA in the near future."
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 2000 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(TM), for the treatment of
Exocrine Pancreatic Insufficiency and filed the first segment of its rolling
NDA for this product in June 2007. Eurand's technology platforms include
bioavailability enhancement of poorly soluble drugs, customized release,
taste-making/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.
Certain statements made in this release, and oral statements made with
respect to information contained in this release, may constitute
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.
The words "potentially", "could", "calls for" and similar expressions will
some times 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. 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.
Web site: http://www.eurand.com
Marian Cutler, Vice President, Corporate Communications of Eurand, +1-267-759-9324, Marian.Cutler@eurand.com; Nick Laudico, +1-646-536-7030, nlaudico@theruthgroup.com, or Elizabeth Scott, +1-646-536-7014, escott@theruthgroup.com, both of The Ruth Group