February 5, 2020

Mitsubishi Tanabe Pharma expands domestic co-promotion
framework for STELARA®.
An application for an additional indication has been filed for
ulcerative colitis, which will be included in co-promotion activities.
Mitsubishi Tanabe Pharma Corporation (Head Office: Osaka; President andRepresentative Director: Masayuki Mitsuka; hereafter, Mitsubishi Tanabe Pharma)
has agreed to expand the domestic co-promotion agreement with Janssen
Pharmaceutical K.K. (Headquarters: Chiyoda-ku, Tokyo; President: Chris Hourigan;hereafter, Janssen) for STELARA®. Up to this point, the co-promotion activities of
the two companies have focused on the treatment of Crohn’s disease withSTELARA® (generic name: ustekinumab; (genetically modified)), which is amonoclonal antibody that binds to the p40 subunit of human anti-interleukin (IL)12 and IL-23. Going forward, the two companies have agreed to expand the copromotion framework to include an intravenous infusion form (induction treatment
for moderate to severe ulcerative colitis (which does not adequately respond toconventional treatments)) and a subcutaneous injection form (maintenance therapy
for moderate to severe ulcerative colitis (which does not adequately respond toconventional treatments)). An application for a partial change in manufacturing andmarketing approval items has been submitted for these items.
In accordance with this agreement, Janssen, as the manufacturing distributor ofSTELARA®, will continue to provide the product to Mitsubishi Tanabe Pharma, which
will have sales rights in Japan. In addition, both companies will continue to jointly
provide information to health care professionals.
STELARA® controls inflammation in the gastrointestinal tract by selectively targeting
the IL-12 and IL-23 pathway, an important therapeutic target in inflammatory bowel
disease. In Japan, the intravenous infusion form of this drug has been approved forinduction treatment for moderate to severe Crohn’s disease (which does notadequately respond to conventional treatments). The subcutaneous injection form
has been approved for cases of psoriasis vulgaris and psoriasis arthropathica inwhich existing treatments are not sufficiently effective and for maintenance therapy
for moderate to severe Crohn’s disease (which does not adequately respond toconventional treatments).

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Going forward, in the field of inflammatory bowel disease (Crohn’s disease,ulcerative colitis), Mitsubishi Tanabe Pharma will offer REMICADE® and STELARA®
for the indication of Crohn’s disease and REMICADE® and SIMPONI® and STELARA®
for the indication of ulcerative colitis. In this way, Mitsubishi Tanabe Pharma will
strive to strategically reinforce its foundation in the field of inflammatory bowel
disease and contribute to improvements in patients’ quality of life and to their
medical treatment.
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters inDoshomachi, Osaka, which is the birthplace of Japan’s pharmaceutical industry.
With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is awell-established company and has the longest history of any listed pharmaceuticalcompany in Japan. In accordance with the corporate philosophy of “contributingto the healthier lives of people around the world through the creation ofpharmaceuticals,” the Company formulated the key concept of Open Up the Future
under the Medium-Term Management Plan 16-20. Through the discovery of drugs
that address unmet medical needs, centered on its priority disease areas —Immuno-inflammation, Diabetes and kidney, Central nervous system, Vaccines —Mitsubishi Tanabe Pharma will strive to contribute to the health of patients aroundthe world. For more information, go to https://www.mt-pharma.co.jp/e/2/2