Anika Therapeutics Presents At ING Baring Furman Selz Health Care Conference.

WOBURN, Mass.--(BUSINESS WIRE)--Dec. 14, 1998--

Announces plans for upcoming ORTHOVISC(R) clinical trials

Zimmer exercises option to distribute ORTHOVISC in China

Anika Therapeutics, Inc. (Nasdaq:ANIK) presented an overview of its current business and plans for 1999 in New York today at the ING Baring Furman Selz Health Care Conference.

During his presentation, president and chief executive officer, J. Melville Engle announced Anika's plans to commence a clinical trial for ORTHOVISC(R), a hyaluronic acid (HA) therapy for the treatment of osteoarthritis of the knee, in the United States and also to conduct and fund a second multi-center study in Canada. Both studies will have six-month patient follow-up periods. Engle also said the company's marketing partner, Zimmer, Inc., a division of Bristol-Myers Squibb Company, has exercised its option to distribute ORTHOVISC in China and is moving forward with plans to launch sales of ORTHOVISC in several major European countries during the first quarter of 1999.

According to Engle, these two clinical trials will include patients treated by both rheumatologists and orthopedic surgeons. The company has been working closely with Zimmer to recruit leading doctors to participate in the studies. Details regarding the protocol design and success criteria for the U.S. study are currently being discussed with the U.S. Food and Drug Administration (FDA). The U.S. study will commence following the approval of an Investigational Device Exemption.

"While the FDA determined the first clinical study fell short of demonstrating effectiveness according to predetermined success criteria, statistical significance was established at certain endpoints in a group of 135 patients after the retrospective exclusion of 46 patients with a high degree of pain in the untreated knee," Engle said in his remarks today. He noted the FDA has encouraged Anika to consider the data and clinical experience obtained from the first study in the design of the new trial.

"We firmly believe that ORTHOVISC is safe and provides clinical benefit to patients suffering from osteoarthritis. Based on the data from the first study and on going discussions with the FDA, we plan to refine the protocol design and incorporate what we have learned from the first clinical trial in the new study. We have learned that the degree of pain in the untreated knee for those patients with bilateral osteoarthritis can confound clinical results when only one affected knee is treated. Several retrospective analyses from the first study demonstrated that within the ORTHOVISC treatment group, bilateral osteoarthritis patients with a lower level of pain in the untreated knee responded more favorably than those with a higher level of pain in the untreated knee," Engle added. "In actual practice, bilateral osteoarthritis patients with severe pain often receive HA injections in both knees and we will take this into account in the design of the new study."

A high-molecular weight, highly purified, naturally derived form of 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 after being injected into the joint space three times over a two-week period. It is currently approved for sale in Europe, Canada, Turkey and Israel.

Engle also reviewed Anika's product development pipeline during the conference. He noted the company plans to commence human clinical trials during 1999 for INCERT(R), a HA product designed to prevent post-surgical adhesions. Engle also reported that a clinical paper has been published in the December 1998 Journal of Microsurgery reporting the results of research collaboration with Lahey Clinic to study the use of HA to enhance nerve regeneration. The article stated that the use of Anika's hyaluronic acid enhanced peripheral nerve growth in a preclinical model.

Anika Therapeutics, Inc. develops manufactures and commercializes therapeutic products and devices intended to promote the 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. Anika's currently marketed products consist of ORTHOVISC for the treatment of osteoarthritis in humans and HYVISC(R) for the treatment of equine osteoarthritis. Anika also manufactures AMVISC(R) and AMVISC Plus(R), HA products used as viscoelastic supplements in ophthalmic surgery, for Bausch & Lomb Surgical. Therapies currently under development include INCERT, an HA product 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, combined formulation of basic fibroblast growth factor (bFGF) and 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, the Company will need to successfully design and complete an additional clinical trial or trials to demonstrate the effectiveness of ORTHOVISC. There can be no assurance that such a trial or trials can be completed in a timely manner or at all or, if completed, that the results of such a trial will produce data supporting the effectiveness of ORTHOVISC. Even if the Company is able to successfully design and complete additional clinical trials and the results thereof support the effectiveness 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 the Company will generate sufficient earnings to fund additional clinical studies, thereby, requiring the Company to utilize its cash reserves. There can also be no assurance that Zimmer will be able to successfully launch ORTHOVISC in European countries during the first quarter of 1999. 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.