Nuvo Pharmaceuticals™ Announces District Court Decision to Uphold U.S. Pennsaid® 2% Patent

Monday, May 15, 2017 Drug News
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- U.S. Patent Covering Pennsaid® 2% Infringed by a Proposed Generic Developed by Actavis Laboratories UT, Inc. -    

MISSISSAUGA,

ON, May 15, 2017 /PRNewswire/ - Nuvo Pharmaceuticals Inc. (Nuvo or the Company) (TSX:NRI), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, today
announced that the United States District Court for the District of New Jersey has upheld the validity of Horizon Pharma plc's (Horizon) (NASDAQ:HZNP) U.S. patent covering Pennsaid® (diclofenac sodium topical solution) 2% w/w (Pennsaid 2%), which Actavis Laboratories UT, Inc. (Actavis) has admitted that its proposed generic version of Pennsaid 2% would infringe.  Nuvo earns revenue by selling commercial bottles and physician samples of Pennsaid 2% to Horizon under an exclusive manufacturing and supply agreement that extends to 2029.

On July 6, 2015, Horizon filed a patent infringement lawsuit in District Court against Actavis related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration (FDA) to market a generic version of Pennsaid 2% in the U.S.  The lawsuit claims infringement of Horizon's U.S. Patent No. 9,066,913 ('913 patent) titled "Diclofenac Topical Formulation," which covers Pennsaid 2%.  Horizon has advised Nuvo that the District Court's decision was made based on the validity of Horizon's '913 patent for Pennsaid 2% and that the Court's judgement will prevent Actavis from launching a generic version of Pennsaid 2% in the United States.

Pennsaid 2% has multiple Orange Book listed patents with terms that extend to 2030.

"We are very pleased with the Court's determination that this Pennsaid 2% patent is valid and enforceable," said Tina Loucaides, Nuvo's Vice-President, Secretary and General Counsel.  "This decision means that Nuvo should enjoy revenue from its sales of Pennsaid 2% to Horizon for many years to come."

About Pennsaid 2% Pennsaid 2% is a topical non-steroidal anti-inflammatory drug (NSAID) containing 2% diclofenac sodium.  It is approved by the 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. and Russia. 

About Horizon Pharma plcHorizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs.  The Company markets 11 medicines through its orphan, rheumatology and primary care business units.  For more information, please visit www.horizonpharma.com. 

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 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 E.U. approved manufacturing facility in Varennes, Québec.  For additional information, please visit www.nuvopharmaceuticals.com.

Forward-Looking Statements This Press Release contains "forward-looking statements" within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. Nuvo's actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, readers should not rely on any of these forward-looking statements. Important factors that could cause Nuvo's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in Nuvo's most recent Annual Information Form dated March 1, 2017 under the heading "Risks Factors", and as described from time to time in the reports and disclosure documents filed by Nuvo with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on Nuvo'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 none of Nuvo or any other person assumes responsibility for the accuracy and completeness of these forward-looking statements.

Any forward-looking statement made by the Company in this Press Release is based only on information currently available to it and speaks only as of the date on which it is made. Except as required by applicable securities laws, Nuvo undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

SOURCE Nuvo Pharmaceuticals Inc.



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