Dayton, Ohio (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.
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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
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.
-0-
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
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