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Orthovisc Clinical Trial Data Filed With FDA; Will Third Time Prove A Charm?

This article was originally published in The Gray Sheet

Executive Summary

Anika Therapeutics will seek a marketing partner to distribute its Orthovisc injectable hyaluronic acid if the knee osteoarthritis therapy is approved by FDA

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Anika’s Orthovisc

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...

Anika’s Orthovisc

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...

Anika Will Re-analyze Unfavorable Orthovisc Data, Look To Pipeline Products

Bristol-Myers Squibb's Zimmer unit will continue to sell Anika Therapeutics' Orthovisc outside the U.S. and take a wait-and-see approach toward its contractual obligations in the U.S. while Anika analyzes unfavorable data generated in Phase III U.S. trials.

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