Nuvo Research announces new listing of Synera® Patent in FDA Orange Book
July 25, 2012
MISSISSAUGA, ON, July 25, 2012 /CNW/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain, today announced that the United States Patent Office has granted the reinstatement of Patent No. 6,465,709 related to Synera® Patch (Synera Patent). The Synera Patent expiry date is July 7, 2020.
Nuvo has listed the Synera Patent in the U.S. Food and Drug Administration's (FDA) Orange Book. The Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant seeking FDA approval for a generic version of Synera prior to expiration of the patent to notify Nuvo of its ANDA filing before it can obtain FDA approval.
"We are very pleased that we have received additional patent protection for Synera Patch in the U.S.," said Tina Loucaides, Nuvo's Vice-President and General Counsel. "The listing of this patent in the FDA Orange Book provides us with significantly more years of protection and will allow us to better explore expanded indications for this unique topical local anesthetic patch."
Synera (lidocaine 70 mg/tetracaine 70 mg) Patch is a combination amide and ester local anesthetic topical patch indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company's product portfolio includes Pennsaid®, Pliaglis® and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., the Pharmaceuticals business of Covidien, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global company dedicated to dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, EuroCept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan®) in several European countries. The Company is also developing the compound WF10, for the treatment of immune related diseases.
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the Company's Annual Report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2011. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
SOURCE: Nuvo Research Inc.
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