Nuvo and Galderma Announce FDA Approval of Pliaglis®
MISSISSAUGA, ON, Oct. 22, 2012 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and Galderma Laboratories, L.P., the U.S. affiliate of Galderma Pharma, S.A. (Galderma), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Pliaglis® (lidocaine/tetracaine) 7%/7% Cream. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology.
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 aesthetic procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal.
"We are very pleased that the sNDA for Pliaglis has been approved by the FDA," said Francois Fournier, President of U.S. and Canadian operations of Galderma Laboratories. "Pliaglis offers a pre-treatment solution and contributes to improving the patient experience of an aesthetic treatment."
"This is yet another significant milestone for Nuvo this year," said Dr. Bradley Galer, President of Nuvo's Pain Group. "Pliaglis is an important part of Nuvo's expanded topical pain product portfolio."
Important Safety Information
Indication: PLIAGLIS® Cream 7% / 7% is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. Adverse Events: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%). These reactions were generally mild and transient, resolving spontaneously soon after treatment. The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%. Warnings/Precautions: Methemoglobinemia has been associated with use of local anesthetics such as tetracaine. PLIAGLIS® Cream should be used with caution in patients with sensitivity to any of its components, including para-aminobenzoic acid (PABA), and in patients with severe hepatic disease. PLIAGLIS® Cream is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type. When using PLIAGLIS® Cream in conjunction with other local anesthetic agents, the total dose of anesthetic should be calculated. Contact with the eyes should be avoided.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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. Further more information, please visit www.nuvoresearch.com.
Galderma is a global pharmaceutical company founded in 1981 and exclusively focused on dermatology. The company has 31 wholly-owned affiliates with a worldwide network of distributors and 4,000 employees. Galderma's extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence. In 2011, Galderma acquired Q-Med, a Swedish medical device company specialized in aesthetics, strengthening Galderma's presence in the aesthetic and corrective market.
With approximately 19% of revenues invested each year to discover and develop new products and access innovative technologies, the company is one of the world's leading investors in dermatology R&D. Four state-of-the-art R&D centers, of which Sophia Antipolis in France is one of the largest dermatology sites in the world, and four manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy. Strategic brands in the US include Epiduo®, Oracea®, Clobex®, Differin®, MetroGel®, Vectical® and Cetaphil®. For more information, please visit www.galdermausa.com.
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.