Anika’s Orthovisc
This article was originally published in The Gray Sheet
Executive Summary
J&J Ortho Biotech will launch the injectable hyaluronic acid product for knee osteoarthritis pain in the U.S. following PMA approval, announced Feb. 5. Maker Anika Therapeutics will receive a $20 mil. milestone payment this quarter under a December domestic marketing agreement. Anika estimates the U.S. viscosupplementation market at $350 mil. J&J plans a launch "over the next few months" after a roll-out at the March 10-14 American Academy of Orthopaedic Surgeons meeting in San Francisco. Orthovisc has been available internationally since 1996. An initial PMA was rejected by FDA in 1998, leading to two additional studies and a revised PMA (1"The Gray Sheet" June 9, 2003, p. 27). Competitors include Genzyme Biosurgery's Synvisc, Smith & Nephew's Supartz and Fidia Pharmaceuticals' Hyalgan...