PHILADELPHIA, PA -- (MARKET WIRE) -- 03/10/09 -- Eurand N.V.
(NASDAQ: EURX), a specialty pharmaceutical company that develops
enhanced pharmaceutical and biopharmaceutical products based on its
proprietary drug formulation technologies, announced that the U.S.
Food and Drug Administration (FDA) has granted orphan drug
designation for EUR-1073 (beclomethasone diproprionate) in pediatric
patients. EUR-1073 is a proprietary development product for the
treatment of ulcerative colitis.
Orphan drug status is granted by the FDA to promote the development
of drugs for diseases that affect fewer than 200,000 patients.
Products granted orphan drug status are allowed seven years of market
exclusivity in the U.S. upon FDA approval.
"We are pleased with the FDA's decision, and we believe EUR-1073 has
the potential to address key unmet medical needs of pediatric
with ulcerative colitis," said Gearoid Faherty, Chairman and Chief
Executive Officer. "The development of EUR-1073 is part of our
strategy to develop a pipeline of gastroenterology products to be
marketed by our own sales force, and we believe it would be
complementary to EUR-1008, currently under review by the FDA as a
treatment for exocrine pancreatic insufficiency, a digestive
In April 2008, Eurand acquired from Chiesi Pharmaceutici SpA the
exclusive U.S. and Canadian rights to market EUR-1073, an
enteric-coated, controlled-release formulation of beclomethasone
diproprionate, which Chiesi markets as CLIPPER(TM) in several
European countries for use in the treatment of ulcerative colitis.
About Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease that
produces inflammation and ulcers along the inside of the large
intestine. The inflammation can interfere with the normal function of
the colon, often causing cramping, bloating, diarrhea, bleeding,
fatigue, weight loss and frequent bowel movements which seriously
affect quality of life. Ulcerative colitis is a chronic
relapsing/remitting illness for which there is no known cure:
however, patients can manage their symptoms. A known issue that
arises with ulcerative colitis patients is medication compliance and
excessive pill burden: many currently available ulcerative colitis
treatments require multiple, large pills to be taken several times
daily, and inconvenient means of administration are often involved.
Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes 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. 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.
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 the future and status of the Company's
regulatory filings for EUR-1008, anticipated product launches,
enrollment and future plans for its clinical trials, progress of and
reports of results from clinical studies, clinical development plans
and product development activities. The words "potentially,"
"anticipates," "could," "calls for" 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 does not approve
the Company's NDA relating to EUR-1008; the outcome of any
discussions with the FDA; and unexpected delays or additional
requirements in preparation of materials for submission to the FDA as
a part of the Company's NDA filing, including those relating to
Eurand's raw material supplier. Investors are advised to refer to the
Company's Risk Factors set forth in its Annual Report on Form-20-F as
filed with the U.S. Securities and Exchange Commission.
Forward-looking statements contained in this press release are made
as of this date, and the Company undertakes 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.
Vice President, Investor Relations
Nick Laudico/Sara Ephraim
The Ruth Group
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