Nuvo Research to Receive US$6.0 Million of Milestone Payments from Pliaglis® E.U. Approvals
July 19, 2012
MISSISSAUGA, ON, July 19, 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 Galderma S.A. (Galderma), a global company dedicated to dermatology has received its first three Pliaglis marketing licenses from E.U. countries These licenses entitle Nuvo to receive a total of US$6.0 million of milestone payments from its worldwide Pliaglis marketing partner, Galderma. The milestone payments are due on the earlier of the launch of Pliaglis in the approved countries or 6 months from the date of marketing approval. The payments are expected in December 2012 (US$5.0 million) and January 2013 (US$1.0 million). Galderma has advised Nuvo that it expects to launch Pliaglis in the E.U. and other territories in the first half of 2013.
Nuvo previously filed a Marketing Authorization Application (MAA) for the approval of Pliaglis in 16 E.U. countries using the European Decentralized Procedure and on May 4, 2012 received a positive recommendation that Pliaglis is approvable for the indication of producing local dermal anesthesia on intact skin in adults prior to superficial dermatological procedures. The regulatory process then entered its final phase during which individual countries issue marketing licenses that allow Pliaglis to be marketed in each country. Nuvo expects to receive marketing licenses from the other E.U. countries over the next 12 months.
"We are extremely pleased that Pliaglis is in the process of being approved in a number of E.U. countries and that Nuvo is receiving a substantial regulatory milestone payment as a result," said Dr. Bradley Galer, President of Nuvo's Pain Group. "The upcoming launch of Pliaglis will mean that Nuvo will have 3 growing sources of revenue from globally commercialized topical pain products."
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.
Forward-Looking Statements for Nuvo Research Inc.
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.
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