Anika Therapeutics, Inc. announced it received marketing approval from the US Food and Drug Administration (FDA) for Orthovisc, a highly purified, high molecular weight form of hyaluronic acid for treating pain in patients suffering from osteoarthritis (OA) of the knee.

As recently announced, Orthovisc will be marketed in the US by Ortho Biotech Products, LP. Under its marketing and distribution agreement with Ortho Biotech, Anika will receive a milestone payment for FDA approval of $20 million during the first quarter of 2004. The agreement also calls for potential additional payments contingent on achieving performance and sales threshold milestones, in addition to royalty and transfer fees.

"Receiving FDA approval for Orthovisc is a major milestone for Anika Therapeutics," said CEO Charles Sherwood. "Given the strength of our safety and efficacy data from the Orthovisc clinical trials, we believe there is a significant opportunity to penetrate the US market for viscosupplementation therapy for the treatment of pain from osteoarthritis of the knee." Sherwood noted that the current estimated annual US market for viscosupplementation therapy is approximately $350 million.

The US commercial launch for Orthovisc is expected to take place in conjunction with the annual meeting of the American Academy of Orthopaedic Surgeons to be held in San Francisco March 10-14, 2004. Designed to relieve pain and stiffness and improve joint mobility, Orthovisc has been marketed internationally since 1996, and currently is sold in Canada and various European and Middle Eastern nations.

Greater than 5 per cent of the world's population is afflicted by osteoarthritis of the knee, making it the most common joint disease. Most commonly affecting middle-aged and older people, OA can range from very mild to very severe. Risk factors include being overweight, joint injury, muscle weakness, having other forms of arthritis and heredity. Approximately 10 million Americans currently suffer from OA of the knee and that number is expected to increase.