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.