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SOURCE Nuvo Research Inc.
MISSISSAUGA, ON, Feb. 10, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products today announced the U.S. commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) by its U.S. commercial licensee Mallinckrodt (NYSE:MNK). PENNSAID 2% is the first twice per day topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the United States for the treatment of the pain of osteoarthritis of the knee(s). Nuvo receives royalties on U.S. sales of PENNSAID 2%.
"We believe the commercial launch of PENNSAID 2% has the potential to generate increased sales from which Nuvo can receive increased royalties," said Dan Chicoine, Chairman and co-CEO. "PENNSAID 2% provides a topical treatment option to the millions of U.S. patients suffering from the pain of osteoarthritis of the knee while providing a lower systemic drug exposure than an oral NSAID."
PENNSAID 2% was approved by the U.S. Food and Drug Administration on January 16, 2014. U.S. sales and marketing rights for PENNSAID 2% are licensed to Mallinckrodt by Nuvo Research Inc.
About PENNSAID 2%
PENNSAID 2% is a follow-on product to original PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID 1.5%) which is currently marketed in the U.S. by Mallinckrodt under license from Nuvo. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium compared to 1.5% for original PENNSAID 1.5%. It is more viscous than original PENNSAID 1.5%, is supplied in a metered dose pump bottle and has been approved for twice daily dosing compared to four times a day for original PENNSAID 1.5%.
About Nuvo Research Inc.
Nuvo (TSX:NRI) 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 topical and immunology products.
Nuvo's marketed products include PENNSAID 1.5% (a topical treatment for the signs and symptoms of osteoarthritis of the knee), PENNSAID 2% (a topical treatment for the pain 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.
PENNSAID® (diclofenac sodium topical solution) 2% w/w
IMPORTANT RISK INFORMATION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
WARNINGS AND PRECAUTIONS
USE IN SPECIFIC POPULATIONS
Click here for Full Prescribing Information for additional Important Risk Information including boxed warning.
PENNSAID is a registered trademark of Nuvo Research Inc.
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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