Nuvo Research Inc. has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (together Apotex) respecting patent infringement litigation brought by Nuvo and its US licensing partner, Mallinckrodt Inc. (Mallinckrodt), in response to Apotex’s filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market a generic version of Pennsaid (diclofenac sodium topical solution) 1.5 per cent w/w (Pennsaid).
Under the terms of the settlement agreement, Nuvo and Mallinckrodt granted a license to Apotex that permits Apotex, upon approval of its ANDA by the FDA, to launch its generic version of Pennsaid on a date that is the earlier of 45 days after Mallinckrodt or Nuvo makes a first commercial shipment of Pennsaid (diclofenac sodium topical solution) two per cent w/w (Pennsaid two per cent) in the United States and April 1, 2014, or earlier under certain circumstances.
Pennsaid two per cent is pending approval by the FDA and is expected to be the follow-on product to original Pennsaid. Pennsaid two per cent is designed to be dosed twice per day with a metered dose pump bottle. In 2012, Mallinckrodt submitted a New Drug Application (NDA) for Pennsaid two per cent with the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 4, 2013 for action on the submission.
Pennsaid is a non-steroidal anti-inflammatory drug (NSAID) used for treating the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is the only FDA-approved topical NSAID for the treatment of knee osteoarthritis which demonstrated statistically significant differences in all three primary efficacy endpoints: pain and physical function (Womac), patient overall health assessment (POHA), and patient global assessment of knee osteoarthritis.
Pennsaid is a registered trademark of Nuvo Research Inc.
Womac is a registered trademark of Nicholas Bellamy.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition.