Nuvo Research in patent settlement over Pennsaid

Canada’s Nuvo Research (TSX: NRI) says it has entered into a settlement agreement with Apotex Inc and Apotex Corp respecting patent infringement litigation brought by Nuvo and Nuvo's US licensing partner, Mallinckrodt (NYSE: MKG) in response to Apotex' filing of an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a generic version of Pennsaid (diclofenac sodium topical solution) 1.5% w/w.

Under the terms of the settlement, Nuvo and Mallinckrodt granted a license that permits Apotex, on approval of its ANDA by the FDA, to launch its generic version of Pennsaid, used for treating the signs and symptoms of osteoarthritis of the knee(s), on a date that is the earlier of 45 days after Mallinckrodt or Nuvo makes a first commercial shipment of the drug in the USA and April 1, 2014, or earlier under certain circumstances.

Pennsaid 2% is pending approval by the FDA and is expected to be the follow-on product to original Pennsaid and is designed to be dosed twice per day with a metered dose pump bottle. In 2012, Mallinckrodt submitted a New Drug Application for Pennsaid 2% with the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 4, 2013 for action on the submission.