August 24, 2015

Press Release
Mitsubishi Tanabe Pharma Corporation

Approval of REMICADE® for I.V. Infusion 100, an Anti-Human TNFα Monoclonal
Antibody, for Additional Indications for Entero-Behcet's Disease, Neuro-Behcet's
Disease, and Vasculo-Behcet's Disease

Osaka, Japan, August 24, 2015 - Mitsubishi Tanabe Pharma Corporation (President &Representative Director, CEO: Masayuki Mitsuka) announced today that it has received approval fora partial change of approved information on REMICADE® for I.V. Infusion 100 (generic name:infliximab, hereafter REMICADE®), an anti-human TNFα monoclonal antibody, in relation toadditional indications for entero-Behcet's disease, neuro- Behcet's disease, and vasculo-Behcet's
disease in cases where existing treatment is inadequate.
Behcet's disease (see Reference 1 below) is a generalized inflammatory disease presenting
orogenital aphthous ulcers, skin manifestations, uveoretinitis, and genital ulcers as prominent
symptoms, with characteristic recurring acute inflammatory attacks. Effective treatment for patientswith the following types of Behcet's disease has long been awaited since their outcomes are
particularly poor, as they not only present with prominent symptoms but also develop lesions in thebowels, nerves and blood vessels.
Entero-Behcet's disease: Patients are characterized by having multiple deep ulcers often leading tointestinal perforation, intestinal hemorrhage or perforative peritonitis requiring emergency surgery.
Neuro-Behcet's disease: Patients may develop dementia, psychiatric symptoms, dysarthria or ataxia
due to atrophy of the cerebrum, cerebellum and brainstem.
Vasculo-Behcet's disease: Patients may develop thrombosis, aneurysms or varicose veins that could
be life-threatening if rupture occurs.
The Ministry of Health, Labour and Welfare (MHLW) classifies the seriousness of Behcet's disease
into six stages, from Stage I to Stage VI (see Reference 2 below). While REMICADE® had alreadybeen approved in 2007 for the indication of Behcet’s disease with refractory uveoretinitis, this added
approval will make it possible to cover a wider range of disease conditions and contribute to thetreatment of nearly all patients with Behcet's disease of Stage III or higher.
To address unmet medical needs, Mitsubishi Tanabe Pharma is striving to develop REMICADE® forvarious incurable diseases, including rare diseases, to expand its indications (see Reference 3below). Moving forward, Mitsubishi Tanabe Pharma will continue working to promote appropriate
usage of REMICADE® to obtain thorough efficacy and safety data through post-marketingsurveillance and to establish an adequate sales organization so the product can be used by patientswith peace of mind.
End〈〈For Details, Contact the Following Section〉〉
Corporate Communications Department
Tel +81-6-6205-5211 (Headquarters)

1Reference 1
About Behcet's Disease
Behcet's disease was so-named in 1937 after Hulusi Behcet, a Turkish dermatologist and scientist
who became the first professor at the department of dermatology, Istanbul University, reported thedisease. It is also known as the "Silk Road disease," as it is prevalent in the region spanning fromJapan to the Mediterranean coast from 30 to 45 degrees latitude north. The cause of Behcet's
disease is unknown, but a combination of genetic and external environmental factors including
bacteria and viruses likely causes immunologic abnormalities leading to onset of the disease.
In Japan, Behcet's disease was designated in 1972 as an intractable disease covered by theSpecified Disease Treatment Research Program, with approximately 19,000 patients included.
Prominent symptoms of Behcet's disease, which have sometimes been featured in films and TV
dramas, include serious ocular symptoms often leading to vision loss.

Reference 2
Severity stages of Behcet's Disease (Classification According to the MHLW)Stage I
Stage II
Stage III
Stage IV

Stage V

Stage VI

Presenting with prominent symptoms other than ocular symptoms (aphthousulcers on the oral mucosa, skin manifestations, genital ulcers)
Presenting with iridocyclitis in addition to Stage I symptoms
Presenting with arthritis or epididymitis in addition to Stage I symptoms
Presenting with chorioretinopathy
Presenting with chorioretinopathy and other ocular complications with current or
possible future vision loss
A special type of Behcet's disease (entero-Behcet's disease, vasculo-Behcet'sdisease, neuro-Behcet's disease) that is active or that may have severe sequelae
A special type of Behcet's disease adversely impacting life or prognosisA progressive neuro-Behcet's disease presenting with a greater than moderatedecrease in intellectual function
Death

Reference 3
Indications for REMICADE®
Indications

Approval/Application Date

Crohn’s disease
Rheumatoid arthritis
Behcet’s disease with refractory uveoretinitis
Plaque psoriasis
Psoriatic arthritis
Pustular psoriasis
Psoriatic erythroderma
Ankylosing spondylitis
Ulcerative colitis
Entero-Behcet’s disease
Neuro-Behcet’s disease
Vasculo-Behcet’s disease
Kawasaki disease

Approved in January 2002
Approved in July 2003
Approved in January 2007

Approved in January 2010

Approved in April 2010Approved in June 2010
Approved in August 2015
Filed in May 20152