Nuvo Research® and Horizon Pharma plc Extend Term of Manufacturing Agreement
February 8, 2016
MISSISSAUGA, ON, Feb. 8, 2016 /CNW/ - Nuvo Research Inc. (TSX:NRI), a life sciences company with growing revenues and a diverse portfolio of topical products, today announced it has agreed with Horizon Pharma plc (NASDAQ:HZNP) (Horizon) to extend the term of their manufacturing agreement for the production of PENNSAID® 2% for the U.S. market to December 31, 2029, which extends the agreement by an additional seven years. The amended agreement also provides for tiered pricing based on volumes of product supplied.
"This amendment secures the long-term future of the core business of Nuvo Pharmaceuticals, the commercial healthcare company to be 100% owned by Nuvo shareholders upon completion of our previously announced reorganization of Nuvo into two separate, publicly traded companies," said John London, Nuvo's President and Co-CEO. "We intend to build upon that core business by out-licensing PENNSAID 2% internationally and by seeking to acquire complementary, accretive businesses or products."
About the Reorganization of Nuvo into two separate publicly traded companies
The Company will hold a special meeting of shareholders on February 18, 2016, at which shareholders will be asked to approve the previously announced reorganization of Nuvo into two separate publicly traded companies. If approved, one company, Nuvo Pharmaceuticals Inc. (Nuvo Pharma), would be a revenue and EBITDA generating commercial healthcare company to be owned 100% by Nuvo shareholders. The second company, Crescita Therapeutics Inc. (Crescita), would be a drug development company also initially owned 100% by Nuvo shareholders. Crescita would have a diversified pipeline of product candidates and sufficient cash resources to execute its current business plan for the next 24 months. Completion of the reorganization is subject to a number of conditions including shareholder and court approval. Kingsdale Shareholder Services (Kingsdale) has been retained as proxy solicitation agent on behalf of Nuvo. If you have any questions regarding the voting of your shares, please contact Kingsdale, toll-free in North America at 1-866-581-0510 or call collect outside North America at 416-867-2272 or by email at firstname.lastname@example.org.
If the proposed transaction is approved by shareholders and all other conditions are satisfied, Nuvo expects the transaction to be completed in Q1 2016.
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 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 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.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a growing specialty pharmaceutical company with a diverse portfolio of products and technologies for pain and topical indications. Nuvo's products range from FDA approved, commercial products to development stage drug candidates and technology platforms. 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 Company's future objectives, strategies to achieve those objectives, plans for and timing of the potential development of the Company's product candidates, the proposed reorganization of the Company into two separate publicly-traded companies, 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", "proposed", "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; uncertainties that may delay or negatively impact the proposed reorganization or cause the proposed reorganization to not occur, including the failure to obtain any required approvals; risks relating to the Company's ability to successfully identify, negotiate, implement and/or integrate potential acquisitions of businesses or products; 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 or completeness of these forward-looking statements. Although the forward-looking statements contained in this press release are 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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