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FDA Approves Orthovisc for Treating Osteoarthritis of the Knee

WOBURN, Mass.--(BUSINESS WIRE)--Feb. 5, 2004--Anika Therapeutics, Inc. (Nasdaq:ANIK) today announced it received marketing approval from the U.S. Food and Drug Administration (FDA) for ORTHOVISC(R), 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(R) will be marketed in the U.S. by Ortho Biotech Products, L.P. 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 Chief Executive Officer Charles H. Sherwood, Ph.D. "Given the strength of our safety and efficacy data from the ORTHOVISC clinical trials, we believe there is a significant opportunity to penetrate the U.S. market for viscosupplementation therapy for the treatment of pain from osteoarthritis of the knee." Sherwood noted that the current estimated annual U.S. market for viscosupplementation therapy is approximately $350 million.

The U.S. 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.

Product Summary
ORTHOVISC is indicated for the treatment of pain in OA of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, such as acetaminophen. It is a sterile, non-pyrogenic, clear, viscoelastic solution of hyaluronan contained in a single-use syringe. ORTHOVISC consists of high molecular weight, ultra-pure natural hyaluronan dissolved in physiological saline. A natural complex sugar of the glycosaminoglycan family, hyaluronan is a high molecular weight polysaccharide composed of repeating disaccharide units of sodium glucuronate and N-acetylglucosamine. The hyaluronan is extracted from rooster combs. ORTHOVISC is injected into the knee joint in a series of intra-articular injections one week apart.

Clinical Synopsis
The FDA approval of ORTHOVISC is based on integrated effectiveness data from two randomized, controlled, double-blind multi-center Phase III U.S. clinical studies encompassing a total of 458 patients suffering from OA of the knee. Safety data from a third U.S. trial were also included in the FDA review.

The objective of the studies was to assess the effectiveness of ORTHOVISC for the treatment of joint pain. Patients were divided into three and four ORTHOVISC injection regimen groups and two control groups: arthrocentesis and saline injection. Patients were evaluated for improvement in pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at four follow-up assessments over weeks 7 through 22 of the studies. The primary effectiveness analysis compared the proportion of ORTHOVISC patients achieving a greater improvement from baseline in WOMAC pain score versus controls. Patients in both groups experienced a statistically significant improvement as measured by change in WOMAC pain scores. An integrated safety analysis, which included 562 patients treated with ORTHOVISC, had an extremely low rate of adverse events. There were no serious adverse events associated with ORTHOVISC.

About Osteoarthritis (OA) of the Knee
Greater than 5% 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.

OA of the knee is characterized by the breakdown of cartilage, the part of the joint that cushions the ends of bones, causing bones to rub against each other, resulting in pain and loss of movement. Degradation changes in the synovial fluid contained in the joint may also play a role in OA. Synovial fluid, which mostly consists of hyaluronan, lubricates the joint and is needed to facilitate movement of the joint.

Standard treatment modalities that seek to relieve pain, improve mobility and increase range of motion include analgesics, nonsteroidal anti-inflammatory drug (NSAIDS), viscosupplementation and intra-articular steroids. Should these approaches become insufficient or fail, some patients may become surgical candidates. Viscosupplementation represents an effective, safe, convenient and non-surgical therapeutic alternative or adjunct to physical therapy, medication or surgery.

Source: Anika Therapeutics, Inc.

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