Nuvo Research Announces Successful Pennsaid®2% Phase 3 Trial for Russia
November 5, 2015
MISSISSAUGA, ON, Nov. 5, 2015 /CNW/ - Nuvo Research Inc. (TSX:NRI) (Nuvo or the Company), a specialty pharmaceutical company with growing revenues and a diverse portfolio of topical and immunology products, today announced the successful completion of a Pennsaid 2% Phase 3 clinical trial sponsored by NovaMedica LLC (NovaMedica), Nuvo's licensee for Pennsaid 2% in Russia and some of the Community of Independent States. NovaMedica has advised that the 7-week Russian study of 95 patients with osteoarthritis (OA) of the knee met its required endpoints and that NovaMedica intends to file for regulatory approval of Pennsaid 2% in Russia.
"This is an important step forward for Nuvo as we execute our plan to maximize global Pennsaid 2% revenues through out-licensing agreements with strong commercial partners like NovaMedica," said John London, Nuvo's President and Co-CEO. "It also supports our previously announced strategy of spinning out our biotech drug development business into a separate public company owned by Nuvo shareholders. This will result in Nuvo, which will retain the Pennsaid and Pennsaid 2% franchises, becoming a profitable pure-play commercial health care company with growing revenue."
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 original 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 original Pennsaid. Pennsaid 2% is protected by multiple U.S. patents that are listed in the U.S. Food and Drug Administration's (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, including a granted patent in Russia that expires in 2027.
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.
About Nuvo's Plans to Split Nuvo into Two Separate Public Companies
On September 15, 2015, Nuvo announced that it plans to split Nuvo into two separate, publicly traded companies. The strategy is intended to enhance long-term value for Nuvo shareholders. One company will be a pure-play commercial healthcare company with growing revenue, significant EBITDA and significant EBITDA growth potential. The other company will be a pure-play biotech development company with a deep pipeline of product candidates. The companies will be distinct and separately traded public companies. Nuvo shareholders will receive shares of both companies. Nuvo's cash balance will put both companies in a strong position for growth. Complete details of the proposed transaction and each company will be set forth in an information circular that will be mailed to Nuvo's shareholders 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 and U.S. 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.
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 currently has four commercial products, a pipeline of topical and transdermal products focusing on pain and dermatology and multiple 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 and an immune system modulation platform that supports the development of drug products that modulate chronic inflammation processes resulting in a therapeutic benefit. For additional Company information visit www.nuvoresearch.com.
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, 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", "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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