FDA Approves ORTHOVISC for Treating Osteoarthritis of the Knee; Anika to Receive $20 Million Milestone Payment from U.S. Marketing Partner.

Business Editors/Health/Medical Writers

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.

About Anika Therapeutics, Inc.

Headquartered in Woburn, Mass., Anika Therapeutics, Inc. (www.anikatherapeutics.com) develops, manufactures and commercializes therapeutic products and devices intended to promote the repair, protection and healing of bone, cartilage and soft tissue. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. In addition to ORTHOVISC(R), a treatment for osteoarthritis of the knee, Anika markets HYVISC(R) in the U.S. for the treatment of equine osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC(R) and AMVISC(R) Plus, HA viscoelastic products for ophthalmic surgery, for Bausch & Lomb. It also produces CoEase(TM), which is marketed by Advanced Medical Optics, Inc., STAARVISC(TM)-II distributed by STAAR Surgical Company and Shellgel(TM) for Cytosol Ophthalmics, Inc.

The statements made in this press release which are not statements of historical fact are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, statements that may be identified by words such as "expectations," "remains," "focus," "expected," "prospective," "expanding," "building," "continue," "progress," "efforts," "hope," "believe," "objectives," opportunities," "will," "seek," and other expressions which are predictions of or indicate future events and trends and which do not constitute historical matters identify forward-looking statements. The statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. The Company's actual results could differ materially from any anticipated future results, performance or achievements described in the forward-looking statements as a result of a number of factors, including: commercialization of the Company's products, the risk that the distribution arrangement for ORTHOVISC will not result in meaningful sales; the failure to achieve performance and sales threshold milestones pursuant to the license and supply agreement with Ortho Biotech Products, L.P.; the impact of competitive products; and the failure of the estimated size of the market to be achieved. There can be no assurances that the Company's increased unit sales will materially increase product revenue or improve gross margins. Certain other factors that might cause the Company's actual results to differ materially from those in the forward-looking statements include those set forth under the headings "Business," "Risk Factors and Certain Factors Affecting Future Operating Results" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in each of the Company's Annual Report on Form 10-K for the year ended December 31, 2002, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 and Current Reports on Form 8-K, as well as those described in the Company's other press releases and SEC filings.