Nuvo Research® Provides Update on Pennsaid® 2% Phase 3 Clinical Trial
- Top line results expected in Q1 2016 -
MISSISSAUGA, ON, Dec. 3, 2015 /PRNewswire/ - Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company with growing revenues and a diverse portfolio of topical and immunology products, today provided an update on its ongoing Phase 3 clinical trial (the Trial) of Pennsaid 2% for the treatment of patients who have suffered an acute ankle sprain.
Trial Status
The Trial, which is being conducted in Germany, commenced in July of this year. As of November 25, 2015, 96 patients have been enrolled. The Company is targeting a total enrollment of 124 patients. The Company expects the Trial to be completed and top line results available in Q1 2016.
Clinical Regulatory Requirements for International Marketing Approvals
The Trial is being conducted to support regulatory applications for marketing approval of Pennsaid 2% for the treatment of acute pain in the E.U., Canada and Australia. The Company believes that most other jurisdictions will base their marketing approval on the current U.S. Food and Drug Administration (FDA) approval of Pennsaid 2% for the treatment of the pain of osteoarthritis (OA) of the knee and will not require additional clinical efficacy data. Some jurisdictions, most notably Russia, China and Japan, will require local trials.
Progress on Out-licensing Discussions
The Company has engaged in preliminary discussions with a number of potential international licensing partners that have expressed an interest in licensing the marketing rights for Pennsaid 2% in jurisdictions in which they operate. PricewaterhouseCoopers Corporate Finance Inc. (PwC) is assisting the Company in identifying, contacting and qualifying potential licensees for available territories using its international offices and contacts. The Company expects to complete some out-licensing transactions in 2016 with initial commercial launches commencing in 2017.
Available Territories
Pennsaid 2% was approved by the FDA on January 16, 2014. In October 2014, the Company sold the U.S. rights to Pennsaid 2% to Horizon Pharma plc (Horizon) for US$45.0 million. The Company has already licensed Pennsaid 2% marketing rights to Paladin Labs Inc. for Canada, to NovaMedica LLC (NovaMedica) for Russia and some of the Community of Independent States (CIS) and to Vianex S.A. for Greece, although it has not yet been approved for marketing in those territories. The Company recently announced that NovaMedica, Nuvo's licensee for Pennsaid 2%, in Russia and some of the CIS has advised the Company that it successfully completed a Phase 3 clinical trial of Pennsaid 2% in Russia and that it plans to submit to the Russian regulatory authorities in support of an application for Russian marketing approval. Pennsaid 2% is available for out-licensing in all other territories. An information sheet outlining the licensing opportunity has been posted to the Company's website at www.nuvoresearch.com.
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 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 multiple 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 PwC Canada
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About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company with a diverse portfolio of products and technologies. On September 15, 2015, Nuvo announced that it plans to split Nuvo into two separate, publicly traded companies. One company, to be known as Nuvo Pharmaceuticals Inc. (Nuvo Pharma), would be a pure-play commercial healthcare company that would own the Company's Pennsaid and Pennsaid 2% franchises and related assets and have positive revenue and EBITDA. The other company, to be known as Crescita Therapeutics Inc. (Crescita), would be a pure-play biotech development company that would own the Company's existing drug development business including its pipeline of product candidates. The companies would be distinct and separately traded public companies. Nuvo shareholders would receive shares of both companies. Complete details of the proposed transaction will be set forth in an information circular that will be mailed to Nuvo's shareholders in Q1 2016 in connection with a special meeting that will be called by Nuvo to approve the proposed transaction. Completion of the proposed transaction is subject to certain conditions, including final approval by the Nuvo Board of Directors, confirmation of the potential tax-free nature of the transaction for Canadian shareholders, regulatory approval requirements and the approval of Nuvo's shareholders. If approved by shareholders, Nuvo expects the proposed transaction would be completed in Q1 2016 (subject to the satisfaction of all conditions). However, there can be no assurances regarding the ultimate timing of the proposed transaction or that the proposed transaction will be completed. For additional company information visit www.nuvoresearch.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, statements concerning the potential spin-off of Nuvo's drug development business, the benefits of the spin-off to Nuvo's shareholders and to each company, the taxable nature of the spin-off, the expected financial results and condition of each company, each company's future objectives and strategies to achieve those objectives, the future prospects of each company as an independent company, potential regulatory approval for Pennsaid 2% in Russia, and other statements concerning the Company's future objectives, strategies to achieve those objectives, as well as 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", "potentially" 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, uncertainties that may delay or negatively impact the spin-off or cause the spin-off to not occur; uncertainties related to each company's ability to realize the anticipated benefits of the spin-off, including new focus and anticipated growth; disruptions to operations as a result of effecting the spin-off; risks and uncertainties related to obtaining approvals, rulings and consents, or satisfying other requirements, necessary or desirable to permit or facilitate completion of the spinoff future factors that may arise making it inadvisable to proceed with, or advisable to delay, all or part of the spin-off, the impact of the spinoff on the trading prices for, and market for trading in, the shares of each company, as well as other risk factors included in the Company's Annual Information Form dated February 19, 2015 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 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 Research Inc.
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