Anika Therapeutics Files for FDA Approval to Market ORTHOVISC Osteoarthritis Therapy; Also Announces Entry into New International Markets for ORTHOVISC and CoEase Products.

Business Editors/Health/Medical Writers

WOBURN, Mass.--(BUSINESS WIRE)--June 3, 2003

Anika Therapeutics, Inc. (Nasdaq:ANIK) today announced it has submitted the third and final module of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for ORTHOVISC(R), a hyaluronic acid (HA) preparation for the treatment of osteoarthritis of the knee. The final module includes data from the most recent ORTHOVISC clinical trial. The first two modules of the PMA, which included manufacturing and pre-clinical information, have already been reviewed by the FDA and all outstanding questions have been addressed.

Anika's PMA application to the FDA includes data from a Phase III clinical study, including approximately 360 patients at 24 centers in the U.S. and Canada with monitoring for six months after treatment. The trial was designed to evaluate the safety and effectiveness of ORTHOVISC in reducing joint pain and other symptoms of osteoarthritis of the knee. Osteoarthritis is a degenerative joint disease associated with aging that is characterized by joint pain, stiffness and the loss of mobility. More than 10 million Americans suffer from osteoarthritis of the knee.

"We are pleased to have submitted the third and final module of this filing, which includes clinical data we feel are worthy for approval," said Charles H. Sherwood, Ph.D., president and chief executive officer. "Assuming we receive approval from the FDA, this will open up a significant new market for ORTHOVISC." Sherwood added that Anika is initiating discussions with prospective U.S. marketing partners.

ORTHOVISC is an ultra-pure, high-molecular weight, naturally derived HA, designed to emulate the viscoelastic, lubricating and cushioning properties of natural HA contained in the synovial fluid of healthy joints. HA coats, lubricates and provides shock absorption protection to joint tissues. ORTHOVISC is injected into the joint space to provide viscosupplementation and pain relief. Having received CE Mark approval in 1996, ORTHOVISC is currently marketed in Canada, and several nations in Europe and the Middle East.

Separately, Anika announced it has extended its existing marketing and distribution relationship with Zurich-based Pharmaren AG, its ORTHOVISC distributor for Turkey, to include distribution rights for Egypt, where marketing approval has been received.

Anika also announced two developments regarding its line of ophthalmic viscoelastic products used in eye surgery. Anika said it has ended a distribution agreement for ophthalmic viscoelastic products made in late 2001 with Miami-based A.M.A. Pharmaceuticals covering Latin and Central America. It also extended an existing agreement with Advanced Medical Optics, Inc., the U.S. distributor for Anika's CoEase(TM) product, to include Canada as well. Approval to sell CoEase has been received from Health Canada and product sales are expected to begin in June.

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.

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," "intend," "our goal," "our strategy," "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. These statements also include statements regarding: (i) the Company's efforts and expectations in entering into long-term arrangements to market and distribute ophthalmic and osteoarthritis products, (ii) the level and timing of the Company's revenue or sales in particular geographic areas and/or for particular products, (iii) the market share of any of the Company's products, (iv) expectations regarding future results of operations, (v) the Company's intention to strengthen, expand and grow its ophthalmic franchise, (vi) the Company's goal of obtaining FDA approval for ORTHOVISC(R), (vii) the Company's expectations of the size of the United States market for osteoarthritis of the knee, (viii) the Company's intention to increase market share for ORTHOVISC in international (and, eventually, domestic) markets or otherwise penetrate growing markets for osteoarthritis of the knee, and (ix) the Company's corporate objectives and research and development and collaboration opportunities. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks, uncertainties and other factors. 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: (i) the Company's ability to successfully complete clinical trials of ORTHOVISC(R) on a timely basis or at all, obtain clinical data to support a pre-market approval application and/or FDA approval, and/or receive FDA or other regulatory approvals of ORTHOVISC(R) or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the success of the Company's efforts to improve the financial performance of its business; (iii) the strength of the Turkish economy in general and other economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; or (iv) future determinations by the Company to allocate resources to products and in directions not presently contemplated. Any delay in receiving any regulatory approvals may adversely affect the Company's competitive position. Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved. There is also a risk that (i) the Company's existing distributors or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements; (ii) the Company's efforts to enter into long-term marketing and distribution arrangements will not be successful, including enlisting a domestic distribution partner for ORTHOVISC(R) and replacement distribution partners for ophthalmic viscoelastics products in Latin and Central America; (iii) new distribution arrangements will not result in meaningful sales of the Company's products; or (iv) increased sales of the Company's products, including HYVISC(R), ORTHOVISC(R) or its ophthalmic products will not continue or sales will decrease, any of which may have a material adverse effect on the Company's business and operations. 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 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 March 31, 2003; and Current Reports on Form 8-K, as well as those described in the Company's other press releases and SEC filings.