FDA Issues Complete Response Letter for the Pliaglis sNDA Submission
2012-04-18, Source: Nuvo Research Inc.
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, announced that Galderma Laboratories, L.P., the U.S. affiliate of Galderma Pharma, S.A. (Galderma) received a complete response letter (the Complete Response Letter) from the U.S. Food and Drug Administration (FDA) to the supplemental New Drug Application (sNDA) for Pliaglis (lidocaine and tetracaine) 7%/7% cream. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology.
The Complete Response Letter outlines additional information the FDA requires before it will approve the sNDA for Pliaglis. Nuvo is working with Galderma to fully understand the FDA's requirements as outlined in the Complete Response Letter and the appropriate response. Nuvo will update the market when additional information is available.
Pliaglis is a topical local anesthetic cream that uses Nuvo's proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. Pliaglis is indicated for use on intact skin in adults to provide local analgesia for superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. Pliaglis was initially approved by the FDA in June 2006, but was voluntarily removed from the U.S. market by Galderma in 2008 due to manufacturing issues at Galderma's third-party contract manufacturer. The sNDA concerns a number of manufacturing issues including the transfer of manufacturing to Galderma.
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., a Covidien company, 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 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. 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 Consolidated Financial Statements, Management's Discussion and Analysis, 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.