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Eurand to Be Issued U.S. Patent for Amrix(r) |
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Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
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DAYTON, Ohio, June 3, 2008 (PRIME NEWSWIRE) -- Eurand N.V.
(Nasdaq:EURX), a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies, announced today that the United States Patent and
Trademark Office (USPTO) has provided notice that it will award the
Company U.S. patent No. 7,387,793 on June 17, 2008, entitled
"Modified Release Dosage Forms of Skeletal Muscle Relaxants." The
Company will also be awarded a Patent Term Adjustment of an
additional 470 days, providing Eurand with coverage on Amrix(r) until
at least February 26, 2025.
Eurand's patent will include claims covering Amrix(r)
(cyclobenzaprine hydrochloride), a product currently marketed in the
U.S. by Cephalon, Inc. under license from Eurand. Amrix(r) is the
only approved once-daily formulation of the skeletal muscle relaxant,
cyclobenzaprine hydrochloride, for the relief of muscle spasm
associated with acute, painful musculoskeletal conditions.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "We
are very pleased to have received notice that we will be awarded this
important patent, protecting Amrix(r) into 2025. This newly issued
patent will be particularly meaningful given Cephalon's commitment to
the product and its success thus far in the U.S. marketplace."
About Amrix(r)
Amrix(r) is the first and only FDA-approved once-daily, extended
release skeletal muscle relaxant that is indicated as an adjunct to
rest and physical therapy for the relief of muscle spasm associated
with acute, painful musculoskeletal conditions. The product is
available in 15 and 30 mg dosage strengths. Eurand developed Amrix(r)
using its proprietary Diffucaps(r) technology, which permits
once-daily dosing (unlike other muscle relaxants which are dosed 3-4
times per day). Eurand has out-licensed North American marketing
rights to Cephalon, while it retains ex-North American marketing
rights. According to IMS, Cyclobenzaprine HCl is the most widely
prescribed muscle relaxant in the U.S., representing 37 percent of
the 45 million prescriptions written for muscle relaxants in 2006.
About Eurand
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 partnered 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, intended for the treatment of Exocrine Pancreatic
Insufficiency and has submitted an NDA for this product. 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 words "potentially", "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 refuses to approve our NDA; the
outcome of any discussions with the FDA; and unexpected delays in
preparation of materials for submission to the FDA as a part of our
NDA filing. 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.
CONTACT: Eurand N.V.
Mario Crovetto, Chief Financial Officer
+39 02 95428 521
mario.crovetto@eurand.com
The Ruth Group
Nick Laudico/Sara Ephraim
646-536-7030/7002
nlaudico@theruthgroup.com
sephraim@theruthgroup.com
--- End of Message ---
Eurand N.V.
845 Center Drive Vandalia, Ohio USA
WKN: A0MSPK; ISIN:
NL0000886448;
; Copyright © Hugin AS 2008. All rights reserved.
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