- 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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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
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whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
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SOURCE Nuvo Pharmaceuticals Inc.