Nuvo Research Inc. Announces Marketing Authorization Application For PLIAGLIS® Validated By European Regulatory Agencies
MISSISSAUGA, ON, July 5, 2011 /PRNewswire/ - 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 its Marketing Authorization Application (MAA) for Pliaglis has been validated in the European Union (EU). The MAA was submitted using the decentralized procedure to request marketing approval for Pliaglis for the indication of producing local dermal anaesthesia on intact skin in adults prior to superficial dermatological procedures. Worldwide marketing rights for Pliaglis have been licensed to Galderma Pharma S. A., a global specialty pharmaceutical company focused on dermatology.
"Our optimism regarding approval of Pliaglis in Europe was important in our decision to acquire ZARS Pharma, Inc. Validation of the MAA by regulatory agencies in Europe is an important step towards approval and launch of Pliaglis in key European markets," stated Dan Chicoine, Chairman & Co-Chief Executive Officer of Nuvo. "Based on the timing of the filing, Pliaglis remains on track for approval and launch in a number of EU countries in 2012."
Validation of the Pliaglis MAA for review indicates that the submitted application is complete and ready for review. The MAA was filed in Germany as the Reference Member State and also with regulatory authorities in Austria, Belgium, Denmark, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Sweden and the UK as Concerned Member States. The regulatory agency in each of these countries will evaluate the application to determine whether to recommend approval for the marketing of Pliaglis. Upon approval, the marketing application will be transferred from Nuvo to Galderma, which can then commence launch activities in each approved country.
About Pliaglis
Pliaglis is a topical local anesthetic cream, which uses the Company's proprietary phase-changing topical peel technology. Pliaglis' marketing rights have been licensed worldwide to Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology.
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 focused on 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. For more information, please visit www.nuvoresearch.com.
Forward-Looking Statements
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.
SOURCE Nuvo Research Inc.