Nuvo Pharmaceuticals™ Receives Approval from German Regulatory Authorities to Conduct Pennsaid® 2% Phase 3 Trial for Treatment of Acute Ankle Sprains

Montag, 17.10.2016 13:35 von

PR Newswire

- Trial Results Expected Q2 2017 -

MISSISSAUGA, ON, Oct. 17, 2016 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (TSX: NRI), (Nuvo or the Company), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today announced it has received approval from the German Federal Institute for Drugs and Medical Devices and Ethical Review Committee to conduct a placebo controlled Phase 3 trial of Pennsaid 2% for the treatment of acute ankle sprains (the Trial).  The 130 patient Trial will be conducted in Germany commencing this month.  Topline results are expected to be available in Q2 2017.  The Trial is intended to support regulatory applications for marketing approval of Pennsaid 2% in the E.U., Canada and Australia.

"We are excited to get this Trial underway as it is part of our strategy to expand the Pennsaid 2% brand globally," said John London, Nuvo's President and CEO.  "Although many jurisdictions will base their regulatory approval of Pennsaid 2% on its current FDA approval, the E.U., Canada and Australia require a successful Phase 3 study to support our applications for approval.  We are in ongoing discussions with a number of potential international licensing partners that have the commercial capabilities to effectively market Pennsaid 2% in their respective jurisdictions."

About the Trial
The Trial will be conducted in Germany and will enroll approximately 130 patients who have suffered a grade I or grade II ankle sprain as assessed by the investigator within 12 hours of injury.  Patients will then be randomly assigned on a double-blind basis to an active arm or a placebo arm and will apply either Pennsaid 2% or a placebo consisting of a topical vehicle that includes all of the constituent ingredients of Pennsaid 2%, except its active ingredient diclofenac sodium, to their injured ankle twice a day for 8 days.  The patients will return to the investigational site for in-depth evaluation on days 3, 5 and 8 of treatment.  The primary endpoint for the Trial will be reduction in pain on movement (POM) at day 3.  The Trial will measure a number of secondary endpoints including tenderness, ankle function, ankle swelling, overall assessment of benefit and satisfaction and use of rescue medication.  The Trial will cost approximately CDN$1.5 million spread over the second half of 2016 and the first half of 2017.

About Pennsaid 2%
Pennsaid 2% is topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium.  It is approved by the U.S. Food and Drug Administration (FDA) for treating the pain of osteoarthritis of the knee(s).  Pennsaid 2% is a gel formulation that is supplied in a metered dose pump bottle.  It is the only topical NSAID approved by the FDA for twice daily dosing.  Pennsaid 2% is protected by multiple U.S. patents that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations database or Orange Book. Patents protecting Pennsaid 2% have been issued or are pending in multiple major international territories. Pennsaid 2% has not yet received regulatory approval outside of the U.S. 

About Nuvo Pharmaceuticals Inc.
Nuvo (TSX:NRI) is a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities.  Nuvo has three commercial products that are available in a number of countries; Pennsaid 2%, Pennsaid and the heated lidocaine/tetracaine patch.  Pennsaid 2% is sold in the U.S. by Horizon Pharma plc (NASDAQ:HZNP) and is available for partnering in certain other territories around the world.  Nuvo manufactures Pennsaid for the global market and Pennsaid 2% for the U.S. market at its FDA, Health Canada and EU approved manufacturing facility in Varennes, Québec.  For additional information, please visit www.nuvopharmaceuticals.com.

Forward-Looking Statements

Certain statements in this press release constitute forward-looking information and/or forward-looking statements (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, the future approval, marketing and sale of Pennsaid 2% in certain jurisdictions, 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 "may", "will", "expect", "intend", "believe", "should" or "plans", 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, but are not limited to, general business and economic uncertainties and adverse market conditions; as well as other risk factors included in the Company's Management Information Circular dated December 31, 2015 and the Company's Annual Information Form dated February 17, 2016 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. 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. Although the forward-looking information contained in this press 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 press release are qualified by these cautionary statements. The forward-looking statements contained herein are made as of the date of this press 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 Pharmaceuticals Inc.