2013-12-19 13:32:03 -
Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of products in the areas of topical pain and immunology, and NovaMedica LLC (NovaMedica), a Russian pharmaceutical company, today announced that they have signed a supply and distribution agreement providing NovaMedica the exclusive rights to market and sell Nuvo’s Pennsaid 1.5% and Pennsaid 2% products in Russia and some of the Community of Independent States (CIS).
Pennsaid 1.5% and Pennsaid 2% are used to treat the symptoms and pain of osteoarthritis of the knee. Pennsaid 1.5% is approved by the U.S. Food and Drug Administration (FDA) and is currently being marketed in the U.S., Canada and certain European countries. A new drug application (NDA) for Pennsaid 2% is
currently under review by the FDA which has indicated that it expects to respond to the NDA by February 7, 2014.
Under the terms of the agreement, NovaMedica is responsible for conducting required clinical studies and obtaining regulatory approval for the products in the licensed territories. Sales of Pennsaid 1.5% in Russia are projected to begin in 2015.
“With an established sales force and excellent knowledge of the Russian pharmaceutical market, NovaMedica is the ideal commercial partner to obtain approval for and market Pennsaid 1.5% and Pennsaid 2% in Russia,” said Dan Chicoine, Chairman and Co-CEO of Nuvo. “Pennsaid 1.5% is currently marketed in five countries, and we will continue to expand its market potential by seeking marketing partners throughout the world.”
“This agreement brings together the advanced expertise and innovative scientific potential of Nuvo Research and our clinical, regulatory and commercial capabilities in Russia, an ideal combination to bring this innovative drug to Russian and CIS patients. We expect these products have a big potential to become an effective and safe solution for unmet needs in our markets,” said Fabrice Egros, COO of NovaMedica. “Our company is committed to contribute to the improvement of Russian health care and will continue to address the Russian market with innovative medicines.”
About Pennsaid 1.5%
Pennsaid is used to treat the signs and symptoms associated with knee osteoarthritis (OA). The drug combines the transdermal carrier (containing dimethyl sulfoxide, popularly known as DMSO) with 1.5% diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) and delivers the active drug through the skin directly to the site of inflammation and pain. Pennsaid is currently marketed in the United States by Mallinckrodt Inc., in Canada by Paladin Labs Inc. and marketed under license and/or distribution agreements in Greece, Italy and the United Kingdom.
About Pennsaid 2%
Pennsaid 2% is a follow-on product to original Pennsaid. Pennsaid 2% contains 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is more viscous than original Pennsaid, is supplied in a metered dose pump bottle and was studied in clinical trials using twice daily dosing compared to four times a day for original Pennsaid. In August 2013, Mallinckrodt advised Nuvo that the FDA accepted a resubmission of a New Drug Application (NDA) for Pennsaid 2% for review and set a Prescription Drug User Fee Act (PDUFA) date of February 7, 2014 for action on the submission.
About Nuvo Research Inc.
Nuvo (TSX: NRI) is a specialty pharmaceutical company focused on improving patients’ lives by developing and commercializing innovative products that address unmet medical needs. Nuvo 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 : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
NovaMedica is a Russian pharmaceutical company established in 2012 by DRI Holdings Limited, a portfolio company of Domain Associates LLC, and Russian investment corporation RUSNANO, which implements government policy on the development of hi-tech industries. NovaMedica’s strategy is aimed at localizing production of a wide range of new medicines and technologies in the Russian market, including screening and registration, and the creation of innovative GMP-standard manufacturing facilities. www.novamedica.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..
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 Nuvo’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 Nuvo’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 Nuvo with Canadian securities regulatory agencies and commissions. This list is not exhaustive of the factors that may impact Nuvo’s forward-looking statements. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo’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 Nuvo 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, Nuvo 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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