Seikagaku announces U.S. FDA approval of Gel-One, a single injection Hyaluronic Acid injectable treatment for osteoarthritis pain of the knee.

March 24, 2011 Seikagaku Corporation (Securities Code: 4548) Seikagaku announces U.S. FDA approval of Gel-One®, a single injection Hyaluronic Acid injectable treatment for osteoarthritis pain of the knee. Tokyo, Japan, March 24, 2011－Seikagaku Corporation (“Seikagaku”) (head office: Chiyoda-ku, Tokyo) today announced that the U.S. Food and Drug Administration (FDA) approved Gel-One® (development code: Gel-200), a medical device for the treatment of pain in osteoarthritis of the knee, on March 22, 2011 (U.S. local time) Gel-One® is a single injection viscosupplement composed of a cross-linked, viscoelastic hyaluronate hydrogel created using technology developed by Seikagaku. It has a high viscosity resulting in residual presence in the knee joint cavity, which enables long-term pain relief in a single injection. The aging population in the U.S. is leading to an upward trend in the incidence of knee osteoarthritis. There is a growing need for orthopaedic treatments, including joint-injectable products that provide long-term benefits through a small number of injections. Seikagaku plans to launch Gel-One® in 2011 through a distribution agreement with Zimmer, Inc. (Warsaw, Indiana, U.S.A.) With the launch of Gel-One®, Seikagaku will offer knee osteoarthritis sufferers a single injection treatment option in addition to the Company’s existing SUPARTZ®, administered in multiple injections. Seikagaku’s goal is to strengthen its presence in the U.S. by expanding sales of both SUPARTZ® and Gel-One®. Background Information Knee osteoarthritis Knee osteoarthritis is a disease characterized by the degeneration of articular cartilage and consequent swelling and pain. A common therapy used to curb the progress of the disease for osteoarthritis knee pain is the injection of hyaluronic acid. Hyaluronic acid injections into the knee joint restore the natural lubrication and shock- absorbing properties of synovial fluid leading to pain relief. #######

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