July 10, 2015

Press Release
Mitsubishi Tanabe Pharma Corporation

Application Filed for a Partial Change in Dosage and Usage of REMICADE® for I.V.
Infusion 100, an Anti-Human TNFα Monoclonal Antibody, in Psoriasis

Osaka, Japan, July 10, 2015 - Mitsubishi Tanabe Pharma Corporation (President & Representative
Director, CEO: Masayuki Mitsuka) announced today that it has filed an application for a partialchange of approved information regarding dosage and usage for REMICADE® for I.V. Infusion 100(generic name: infliximab, hereafter REMICADE®), an anti-human TNFα monoclonal antibody. Thisapplication comes as a result of verified effectiveness and safety of increased dosage in a clinical
trial conducted by the Company in patients with psoriasis whose response to this drug wasdecreasing.
Psoriasis is an intractable immunologic skin disease of unknown cause with such inflammatory
symptoms as swelling skin rashes, and dried, silvery scurf-like scales exfoliating from the skin.
Psoriasis is a disease well-known for seriously impairing the patients' quality of life due to severe
emotional distress.
In January 2010, Mitsubishi Tanabe Pharma received approval for REMICADE® as treatment for fourtypes of psoriasis (plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma).
The Company has contributed to the improvement of quality of life of many patients with psoriasis.
Meanwhile, wearing-off of effects in some patients on this drug remained an issue, and increased
dosage as well as shorter dosing intervals had been requested.
Professor Hidemi Nakagawa, Department of Dermatology, the Jikei University School of Medicine,
who served as coordinating investigator of the clinical trial, commented as follows: "Increaseddosage of this drug in psoriasis has not yet been approved in other countries. Mitsubishi Tanabe
Pharma, in response to the needs of the medical frontlines, conducted clinical trials in Japan andfiled an application. When approved, an increased dosage will be additional good news to patients inneed of treatment with this drug. Each clinical trial conducted through cooperation among thecompany, the physicians and academia, clarifies evidence concerning therapeutic effect and adverse
reactions, and will definitely lead to improvement of quality of life of patients in need of this drug. In
this sense, information about the range of indications as well as effectiveness and safety based on
the evidence gained by clinical trial is indispensable in assessing the product value of a drug."
To address unmet medical needs, Mitsubishi Tanabe Pharma is striving to develop REMICADE® forvarious incurable diseases including rare diseases to expand indications (see reference below).
Moving forward, Mitsubishi Tanabe Pharma will continue working to promote appropriate usage ofREMICADE®, to thoroughly obtain efficacy and safety data through post-marketing surveillance andto establish an adequate sales organization so products can be used with peace of mind by patients.
End〈〈For Details, Contact the Following Section〉〉
Corporate Communications Department
Tel +81-6-6205-5211 (Headquarters)
Tel +81-3-6748-7664 (Tokyo Head Office)1

ReferenceIndications for REMICADE®
Indications

Approval/Application Date

Crohn’s disease

Approved in January 2002

Rheumatoid arthritis

Approved in July 2003

Behcet’s disease with refractory uveoretinitis

Approved in January 2007

Plaque psoriasis
Psoriatic arthritis

Approved in January 2010

Pustular psoriasis
Psoriatic erythroderma
Ankylosing spondylitis

Approved in April 2010

Ulcerative colitis

Approved in June 2010

Intestinal-Behcet’s disease
Neuro-Behcet’s disease

Filed in October 2014

Vasculo-Behcet’s disease
Kawasaki disease

Filed in May 20152