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

- 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 plc
Horizon 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
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SOURCE Nuvo Pharmaceuticals Inc.