Anika Therapeutics Enrolls First Patient in U.S. Clinical Study for Monovisc™

Business Wire, Jan 7, 2008

Company Commences Study of MONOVISC for Single-Injection Joint Pain Relief of Osteoarthritis in the Knee

BEDFORD, Mass. -- Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has enrolled the first patient in a multi-center study evaluating its single-injection osteoarthritis product, MONOVISC([TM]).

The randomized, double-blind, controlled study is designed to demonstrate that the single-injection MONOVISC safely provides symptomatic relief of knee pain and associated dysfunction in patients with osteoarthritis. Anika plans to enroll approximately 350 patients at up to 20 sites in the United States and Canada.

"The initiation of this study is a key step toward commercialization of our MONOVISC product in the United States," said Charles H. Sherwood, Ph.D., Anika's president and chief executive officer. "MONOVISC leverages our new technology platform using a cross-linked, non-animal source of hyaluronic acid (HA), delivered in an easy-to-use, single injection format. Administering this solution through a single injection can offer a convenient option for doctors and patients."

Anika received European CE Mark approval for MONOVISC in September 2007 and expects to launch MONOVISC in Europe in the first half of 2008.

About Anika Therapeutics, Inc.

Headquartered in Woburn, Mass., Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products for tissue protection, healing and repair. These products are based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Anika's products include ORTHOVISC([R]), a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by DePuy Mitek; HYVISC([R]), a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.; the ELEVESS([TM]) family of aesthetic dermatology products for facial wrinkles, scar remediation and lip augmentation; AMVISC([R],) AMVISC([R]) Plus, STAARVISC[TM]-II and Shellgel[TM] injectable viscoelastic HA products for ophthalmic surgery; INCERT([R]), an HA-based anti-adhesive for surgical applications; and next generation products for joint health and aesthetic dermatology based on the Company's proprietary, chemically modified HA.

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," "plan(s)," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," "expect" 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: (i) the Company's expectations concerning its MONOVISC product, (ii) statements concerning the U.S. clinical study of MONOVISC, and (iii) the Company's expectation that it will launch MONOVISC in Europe in the first quarter of 2008. 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 commence and/or complete clinical trials of its products 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 its products, or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the Company's research and product development efforts and their relative success, including whether the Company has any meaningful sales of any new products resulting from such efforts; (iii) the cost effectiveness and efficiency of our manufacturing operations and production planning; (iv) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas or (v) 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, including with new international distributors for MONOVISC, will not be successful, (iii) new distribution arrangements will not result in meaningful sales of the Company's products, (iv) the Company will be unable to achieve performance and sales threshold milestones in its distribution agreements, (v) competitive products will adversely impact the Company's product sales, (vi) the estimated size(s) of the markets which the Company has targeted its products will fail to be achieved, or (vii) lack of adequate coverage and reimbursement provided by governments and other third party payers for our products and services, could have a material adverse effect on our results of operations, 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 "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, 2006 and on Form 10-Q for the period ended September 30, 2007, as well as those described in the Company's other press releases and SEC filings.