Anika Therapeutics Receives FDA Approval to Initiate ORTHOVISC Phase III Clinical Study; Study Scheduled to Commence in April in U.S. and Canada.

WOBURN, Mass.--(BUSINESS WIRE)--March 29, 1999--Anika Therapeutics, Inc. (Nasdaq:ANIK) today announced it has received U.S. Food and Drug Administration (FDA) approval under an Investigational Device Exemption (IDE) to commence a Phase III clinical study for ORTHOVISC(R) sodium hyaluronate, a treatment for osteoarthritis of the knee. The company submitted the IDE to the FDA in February 1999.

The study is scheduled to commence in April and will include leading orthopedic surgeons and rheumatologists at up to 20 clinical centers in the United States and Canada. The prospective, randomized, double blind study will assess the safety and effectiveness of ORTHOVISC in comparison to a saline control. As many as 350 patients will be enrolled in the study and the treatment regimen will consist of three intra-articular injections of ORTHOVISC over a two-week interval with a six-month follow-up period. The primary endpoint used to measure the effectiveness of ORTHOVISC will be a reduction in pain based on the WOMAC (Western Ontario McMaster University) pain score, a respected and validated measurement methodology that was used as a secondary endpoint in the first clinical study.

"We have worked diligently over the past couple of months to enroll investigational sites and expect to start the trial in April", said J. Melville Engle, chairman, president and chief executive officer. "We have collaborated with the FDA on the development of our clinical protocol which is based on the results obtained from the first clinical study. We are pleased that the FDA has agreed to allow us to file the Pre-Market Approval (PMA) application in modular form, meaning that all sections of the PMA, excluding the clinical data from the new trial, may be submitted prior to the completion of the study. We expect this to expedite the review process."

A high molecular weight, highly purified, naturally derived form of hyaluronic acid (HA), ORTHOVISC is designed to emulate the viscoelastic and cushioning properties of natural HA found in the synovial fluid of healthy joints. ORTHOVISC coats, lubricates and provides shock absorption protection to joint tissues. ORTHOVISC is approved for sale and marketed by Zimmer, Inc. in Canada and most of Europe, Grupo Ferrer Internacional in Spain and Portugal, Biomeks Pharmaceuticals in Turkey and Rafa Laboratories in Israel.

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, Anika currently markets HYVISC(R) in the U.S. for the treatment of equine osteoarthritis and manufactures AMVISC(R) and AMVISC(R) Plus, highly viscous HA products used as viscoelastic supplements for ophthalmic surgery, for Bausch & Lomb Surgical. Therapies currently under development include INCERT(R), a family of HA products designed to prevent post-surgical adhesions, and HA oligosaccharides for the treatment of cancer. Anika is also collaborating with Orquest, Inc. to manufacture Ossigel(TM), an injectable formulation of basic fibroblast growth factor combined with HA designed to accelerate the healing of bone fractures.

The statements made in this press release which are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company's actual results could differ materially from those set forth in the forward-looking statements as a result of a number of factors. In particular, there can be no assurance that the clinical trial can be completed in a timely manner or at all, or if completed, that the results of the trial will produce data supporting the efficacy of ORTHOVISC. Even if the Company is able to successfully complete the clinical trial and the results thereof support the efficacy of ORTHOVISC, there can be no assurance that the Company will receive FDA or other regulatory approval of ORTHOVISC, or that such approval will be obtained in a timely manner or without the need for additional clinical trials. In addition, there can be no assurance that any delay in receiving any such approval will not adversely effect the Company's competitive position. Certain other factors that might cause the Company's actual results to differ materially from those set forth in the forward-looking statements include those factors set forth under the heading "Risk Factors" in the Company's 10-KSB filed with the Securities and Exchange Commission on March 31, 1998 as well as those listed in the Company's other SEC filings.