Cip-tramadol ER regulatory update

FDA approved an NDA from Cipher for Cip-tramadol ER to treat moderate to moderately severe chronic pain. Cipher, which is seeking a marketing partner, said the drug's launch is dependent on the outcome of a pending appeal in a suit involving controlled-release tramadol patents. Last year, the U.S. District Court for the District of Delaware ruled that the patents were invalid due to obviousness in a suit brought by Purdue Pharma L.P (Stamford, Conn.), Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) and Biovail Corp. (TSX:BVF; NYSE:BVF, Mississauga, Ontario) against Par Pharmaceutical Cos. Inc. (NYSE:PRX, Woodcliff Lake, N.J.). Purdue has appealed the ruling, and a decision is expected late this year.

In a separate case, the U.S. District Court for the District of Virginia granted Cipher's motion for summary judgment that the patents are invalid due to obviousness. Biovail and J&J, have licenses for the patents, which expire in 2014, from Purdue and Napp Pharmaceutical Group Ltd. (Cambridge, U.K.). ...