Nuvo Research announces launch of Synera® in the U.S.
February 2, 2012
MISSISSAUGA, ON, Feb. 2, 2012 /CNW/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10, today announced the U. S. launch of Synera® (70 mg lidocaine/ 70 mg tetracaine/ heated topical patch). Synera is approved by the U.S. Food and Drug Administration (FDA) 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.
Nuvo will be directly marketing Synera to interventional pain doctors with a dedicated 21 person contract sales force. Nuvo believes that there is a significant opportunity for Synera to be used prior to subcutaneous injections for painful needle procedures such as knee drains, epidurals and a variety of nerve blocks. This new sales force will initially target a highly concentrated number of doctors and clinics that perform these painful procedures as a regular part of their practice. Each year, approximately 3,600 U.S. physicians perform 50% of these 23 million interventional needle procedures.
"The launch of Synera is an important milestone for Nuvo as we transition from a purely drug development company into a fully integrated specialty pain company with a dedicated, focused pain specialty sales force," said Dr. Bradley Galer, MD, President of Nuvo's Pain Group. "We believe that Synera has great potential and now represents our second source of revenue, in addition to Pennsaid®. Also, by the end of 2012, we expect E.U. and U.S. approval and the launch of our third commercial product, Pliaglis®, by our worldwide marketing partner, Galderma Pharma S.A."
In the U.S., Nuvo will also be marketing Synera to large national accounts, such as dialysis and infusion centers. Nuvo's U.S. marketing strategy includes out-licensing Synera for the hospital and pediatric markets. Nuvo is in discussion with potential licensees that have the existing infrastructure to sell Synera in those markets.
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 Pain Group, located in West Chester, Pennsylvania, is focused on the development and commercialization of topically delivered pain products. The Company's product portfolio includes Pennsaid, Pliaglis and Synera. Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee. Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company (NYSE: COV), in Canada by Paladin Labs Inc. (TSX:PLB) and in several European countries. Pliaglis is a topical local anesthetic cream, which is U.S. Food and Drug Administration (FDA) approved to provide topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in 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. Through its subsidiary, Nuvo Research GmbH, based in Leipzig, Germany, 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 annual report, as well as in Nuvo's Annual Information Form for the year ended December 31, 2010. 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.
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