Pliaglis receives positive opinion from the BfArM in the E.U.
May 7, 2012
- Enters national licensing phase in 17 E.U. countries
MISSISSAUGA, ON, May 7, 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 that it has received notice of a positive opinion from the European Decentralized Procedure for the approval of Pliaglis from the German Federal Institute for Drugs and Medical Devices (BfArM), the reference member state. The decentralized procedure has been closed with 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 Marketing Authorization Application (MAA) was submitted by Nuvo to 17 E.U. countries using the decentralized submission procedure to request marketing approval for Pliaglis. The regulatory process will now enter its final phase known as the national licensing phase. During this phase, the National Agencies in the individual countries will issue the marketing licenses that allow Pliaglis to be marketed in each country. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma S.A. (Galderma), a global pharmaceutical company specialized in dermatology and the individual country licenses will be issued directly to Galderma. Pursuant to Nuvo's license agreement with Galderma, Nuvo is entitled to receive milestone payments totaling US$6.0 million when certain specified launches occur or within a predefined 6-month period after marketing approval in three different countries.
"We are very pleased that Pliaglis has received a positive recommendation to the MAA supporting its approval in many key European markets," stated Dr. Bradley Galer, President of Nuvo's Pain Group. "This successful result reflects the highly cooperative effort between Nuvo and 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 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.
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 include Epiduo, Oracea, Clobex, Differin, Rozex/MetroGel, Silkis/Vectical, Tri-Luma, Loceryl, Cetaphil, Metvix, Azzalure, Dysport*, Restylane and Emervel.
*Dysport is a trademark of Ipsen
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, 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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