Reply Submitted to Pliaglis FDA Complete Response Letter
MISSISSAUGA, ON, May 8, 2012
MISSISSAUGA, ON, May 8, 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 the development of its immune modulating drug candidate WF10, announced that Galderma Laboratories, L.P., the U.S. affiliate of Galderma S.A. (Galderma) has responded to the U.S. Food and Drug Administration (FDA) Complete Response Letter for Pliaglis (lidocaine and tetracaine Cream 7%/7%). Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology.
On April 16, 2012, Galderma received the Complete Response Letter from the FDA that outlined additional information the FDA requires before it will approve the sNDA for Pliaglis. Galderma has submitted additional information that it believes addresses all of the FDA’s issues. The additional information relates to the manufacturing transfer of Pliaglis from a third-party contract manufacturer to Galderma’s manufacturing facility and includes additional stability data and proposed labeling revisions. The Complete Response Letter did not require any new clinical or toxicology studies. It is expected the FDA will apply a 4-month review period for this information.
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.
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|
Further information on Nuvo Research is available on the company’s website www.nuvoresearch.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 Nuvo’s Annual Report and 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.