Seikagaku Announces Withdrawal of PMA for Additional Indication of SUPARTZ® in the U.S.

Tokyo, Japan, DATE March 30, 2011 – Seikagaku Corporation (head office: Chiyoda-ku,Tokyo) today announced that it has submitted a notice of withdrawal of the premarketapproval application (PMA) for an additional indication for SUPARTZ®, a hyaluronic acidbased agent to treat joint pain.

SUPARTZ® is currently marketed in the U.S. as treatment for knee osteoarthritis.Seikagaku conducted a pivotal clinical trial for an additional indication for treatment ofshoulder osteoarthritis (development code: SI-602) and submitted the PMA inSeptember 2009. Following subsequent discussions with the U.S. Food and DrugAdministration (FDA), Seikagaku has decided that additional clinical studies would beneeded to fully develop SUPARTZ® for use in the shoulder indication and, as a result,Seikagaku made the decision to withdraw the application.

The market for knee osteoarthritis treatment in the U.S. is expanding, and Seikagaku willcontinue to strengthen sales activities of SUPARTZ®. SUPARTZ® is distributed in theU.S. by Smith & Nephew, Inc.

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Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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