Milestone Payment Related to Pliaglis Brazil Approval and Launch
MISSISSAUGA, ON, Oct. 10, 2013 /PRNewswire/ - Nuvo Research Inc. (NRI.TO), 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 the Company has been advised by its worldwide Pliaglis licensing partner, Galderma S.A. (Galderma), that Pliaglis has been approved for sale and marketing in Brazil and that it expects to launch Pliaglis in Brazil in early 2014. This entitles Nuvo to a US$2.0 million milestone payment that it expects to receive from Galderma in early 2014.
"We are pleased that Pliaglis has been approved for sale and marketing in Brazil which is one of the largest potential markets for Pliaglis," said Dr. Bradley Galer, President of Nuvo's Pain Group. "Pliaglis is now approved for sale and marketing in 16 European countries, the United States, Argentina and Brazil with additional approvals expected over the next two years."
Important Safety Information
Indication: PLIAGLIS® (lidocaine and tetracaine) Cream 7% / 7% is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures. Contraindications: 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 and is also contraindicated in patients with sensitivity to para-aminobenzoic (PABA) or any components of the product. Pliaglis should not be used on mucous membranes or on broken or irritated skin. Adverse Events: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%). The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of Warnings/Precautions: Methemoglobinemia has been associated with use of local anesthetics such as tetracaine. PLIAGLIS® Cream should be used with caution in patients with severe hepatic disease. When using PLIAGLIS® Cream in conjunction with other local anesthetic agents, the total dose of anesthetic should be considered due to the potential for additive systemic toxic effects. Contact with the eyes should be avoided. The treated area should not be occluded before removing Pliaglis from the skin.
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 (NRI.TO) is a specialty pharmaceutical company focused on improving patient's lives by developing and commercializing innovative products that address unmet medical needs. The Company has a diverse portfolio of products in the areas of topical pain and immunology.
Nuvo's marketed products include Pennsaid® (a topical treatment for the signs and symptoms of osteoarthritis of the knee), Pliaglis (a topical local anesthetic) and the heated lidocaine/tetracaine patch (HLT Patch). For additional Company information visit www.nuvoresearch.com.
Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime while serving healthcare professionals around the world. The company has 33 wholly-owned affiliates with a worldwide network of distributors and more than 4,500 employees. Galderma's extensive product portfolio is available in 80 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.
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. Five state-of-the-art R&D centers 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®, Restylane® and Emervel®.
Certain statements in this news release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, statements concerning the Company's future objectives, strategies to achieve those objectives, as well as statements with respect to management's beliefs, plans, estimates, and intentions, and similar statements concerning anticipated future events, results, circumstances, performance or expectations that are not historical facts. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "outlook", "objective", "may", "will", "expect", "intend", "estimate", "anticipate", "believe", "should", "plans" or "continue", or similar expressions suggesting future outcomes or events. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those contemplated by such statements. Factors that could cause such differences include the need for additional financing, the current economic environment, dependence on sales and marketing partnerships, competitive developments, as well as other risk factors included in the Company's annual information form dated March 27, 2013 under the heading "Risks Factors" and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. This list is not exhaustive of the factors that may impact the Company's forward-looking statements. These and other factors should be considered carefully and readers should not place undue reliance on the Company's forward-looking statements. As a result of the foregoing and other factors, no assurance can be given as to any such future results, levels of activity or achievements and neither the Company nor any other person assumes responsibility for the accuracy and completeness of these forward-looking statements. The factors underlying current expectations are dynamic and subject to change. Although the forward-looking information contained in this news release is based upon what management believes are reasonable assumptions, there can be no assurance that actual results will be consistent with these forward-looking statements. Certain statements included in this news release may be considered "financial outlook" for purposes of applicable securities laws, and such financial outlook may not be appropriate for purposes other than this news release. All forward-looking statements in this news release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this news release and except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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