July 1, 2011
Press Release
Mitsubishi Tanabe Pharma CorporationApproval for "SIMPONI® Subcutaneous Injection 50mg Syringe(Generic Name: Golimumab)" for Treatment of Rheumatoid Arthritis
Osaka, Japan, July 1, 2011--- Mitsubishi Tanabe Pharma Corporation (President & CEO:Michihiro Tsuchiya) announced today that Janssen Pharmaceutical K.K. (head office:Chiyoda-ku, Tokyo; president: Toon Overstijns; hereinafter “Janssen”) obtained themanufacturing and marketing license for human TNF-α monoclonal antibody, SIMPONI®
Subcutaneous Injection 50mg Syringe (generic name: Golimumab (genetical recombination))that has been co-developed by Janssen and Mitsubishi Tanabe Pharma for thedomestic market, for the treatment of rheumatoid arthritis (including prevention of articularstructural damage) in cases showing inadequate response to conventional therapies.
SIMPONI® is a human TNF-α monoclonal antibody as a subcutaneous injection. It wasdiscovered and developed by Janssen Biotech, Inc. (former Centocor Ortho Biotech Inc.),
USA, as a treatment for inflammatory autoimmune diseases involving TNF-α such as
rheumatoid arthritis. It was approved for the treatment of moderately to severely activerheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis in the U.S. inApril, 2009, and in Europe in October, 2009.
In Japan, Mitsubishi Tanabe Pharma and Janssen have jointly developed SIMPONI® from aPhase 2 trial. In a clinical study, where SIMPONI® was subcutaneously injected to patientswith rheumatoid arthritis every 4 weeks, regression of signs and symptoms of RA,
improvement of physical function, and suppression of progression of joint destruction as well
as safety have been confirmed. Based on the results, application for manufacturing andmarketing of SIMPONI® was submitted in June, 2010, and it was approved for the treatmentof rheumatoid arthritis including prevention of articular structural damage in patients who
showed inadequate response to conventional therapies. Both companies plan to co-market
SIMPONI® soon after its registration in the NHI price listing, which will be under the samebrand name, Mitsubishi Tanabe Pharma will steadily provide healthcare professionals withinformation on the proper use of SIMPONI® for its safe administration in clinical settings.
In most cases, treatment of rheumatoid arthritis is prolonged and requires endurance, andthere has been a continuous yearning for drugs that can reduce the patients’ burden of
frequent hospital visits and administration. SIMPONI® is designed to be administered once
every 4 weeks; it will reduce the frequency of hospital visits and will also ensure proper-1-administration, for it can be used only when injected by a physician.
Since 2002, Mitsubishi Tanabe Pharma has been providing REMICADE®, a TNF- α
monoclonal antibody for intravenous drip infusion, which was discovered and developed by
Janssen Biotech, Inc., to many patients with rheumatoid arthritis, Crohn's disease, psoriasis,and some other inflammatory autoimmune diseases.

Another biological agent, SIMPONI®

will be added to our product lineup for rheumatoid arthritis, and we expect to make a further
contribution to the treatment of patients suffering from rheumatoid arthritis.

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