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FDA Issues Approvable Letter for Orthovisc, Potential Osteoarthritis Treatment

WOBURN, Mass., Dec 2, 2003 (BUSINESS WIRE) -- Anika Therapeutics, Inc. (Nasdaq:ANIK) today said it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for its Pre-Market Approval application (PMA) for ORTHOVISC(R), a highly purified, high molecular weight form of hyaluronic acid for treating patients suffering from osteoarthritis of the knee. The letter states that an approval order will be issued subject to a successful FDA inspection of Anika's manufacturing facility.

"This achievement marks a significant milestone for Anika Therapeutics and we are pleased with the outcome of the FDA's review of our PMA application thus far," said Chief Executive Officer Charles H. Sherwood, Ph.D. "One of our top corporate priorities is to now focus on securing an agreement with a strategic U.S. partner who will lead the commercialization efforts for ORTHOVISC."

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. The U.S. market for viscosupplementation products is growing, with currently over 10 million Americans suffering from osteoarthritis of the knee.

Source: Anika Therapeutics, Inc.

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