Nuvo Research® plans Phase 3 study of Pennsaid® 2% to support international regulatory approvals
November 3, 2014
MISSISSAUGA, ON, Nov. 3, 2014 /CNW/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced that it plans to commence a Phase 3 clinical study of Pennsaid 2% for the treatment of acute pain to support regulatory approval applications for Pennsaid 2% in international jurisdictions. The study will be conducted in Germany to assess the efficacy of Pennsaid 2% for the relief of pain associated with acute, localized muscle or joint injuries such as sprains, strains or sports injuries. Commencement of the study, which is subject to German regulatory approval, is expected in Q2 2015 with top-line results expected Q4 2015. The study will cost approximately CDN$1.5 million.
"This Phase 3 study will support regulatory approval in many jurisdictions, including the European Union and is an integral part of our plan to seek a partner or partners to market Pennsaid 2% internationally and make Pennsaid 2% a global brand," said Dan Chicoine, Nuvo's Chairman and Co-CEO. "While the global topical NSAID market is competitive, we believe that Pennsaid 2%'s superior product attributes make it a very desirable asset for potential licensees."
About the Phase 3 Clinical Study of Pennsaid 2%
The Phase 3 study will be a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Pennsaid 2% for the relief of pain associated with recent (acute), localized muscle or joint injuries such as sprains, strains or sports injuries (for example ankle sprain). The primary endpoint will be change in pain on movement (POM) from day 1 to day 5. It will also measure other secondary endpoints.
About Pennsaid 2%
Pennsaid 2% is a topical product containing 2% diclofenac sodium compared to 1.5% for original Pennsaid. It is approved in the U.S. for pain of osteoarthritis (OA) of the knee(s). It is more viscous than Pennsaid, is supplied in a metered dose pump bottle and has been approved in the U.S. for twice daily dosing compared to four times a day for Pennsaid. Pennsaid 2% is protected by 6 U.S. patents that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database or "Orange Book". Pennsaid 2% has not yet received regulatory approval outside of the U.S. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company with a diverse portfolio of products and technologies. The Company operates two distinct business units: the Topical Products and Technology (TPT) Group and the Immunology Group. The TPT Group has four U.S. Food and Drug Administration (FDA) approved commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and four drug delivery platforms that support the development of patented formulations that can deliver actives into or through the skin. The Immunology Group has two commercial products, a development program for the treatment of allergic rhinitis and an immune system modulation platform that has the potential to support treatments for a broad range of immune system related disorders. For additional company information visit www.nuvoresearch.com.
Certain statements in this MD&A constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to the Company's anticipated use of proceeds from the sale of Pennsaid 2% U.S. rights to Horizon Pharma plc, the litigation settlement with Mallinckrodt Inc. and from the March 2014 Private Placement, the Company's future share price and the Company's possible election to accelerate the expiry date of any of the warrants or the brokers warrants 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 general business and economic uncertainties and adverse market conditions as well as other risk factors included in the Company's Annual Information Form dated February 20, 2014 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. 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.
SOURCE Nuvo Research Inc.
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