AbbVie and Eisai Announce the Launch of HUMIRA Pen, an Auto-Injector Formulation for Fully Human Anti-TNF-alpha Monoclonal Antibody HUMIRA

TOKYO, Jun 11, 2018 - (JCN Newswire) - AbbVie GK, Eisai Co., Ltd. and Eisai's subsidiary for gastrointestinal diseases EA Pharma Co., Ltd.announced that the autoinjection delivery system for HUMIRA (generic name: adalimumab [recombinant], "HUMIRA"), HUMIRA for Subcutaneous Injection 40 mg Pen 0.4 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL, was listed in the National Health Insurance Drug Price Standard on 30th May. AbbVie and Eisai have launched the products today. HUMIRA is a fully human anti-TNF-alpha monoclonal antibody formulation.

The newly launched pen-type auto-injector devices were developed to simplify the operation and reduce the burden on patients when performing self-injection. The rounded pen-type body of this product is designed to fit in the hands of even patients who have a weak grip and conceal the needle tip when injected. In addition to the lock function and autoinjection delivery system which allows for the full amount drug injection in about 10 seconds, it features injection start and end alert sounds and an inspection window. The pen-type auto-injector devices are filled with the same drug solution as the conventional pre-filled syringe devices(1).

HUMIRA is the world's first fully human anti-TNF-alpha monoclonal antibody and works by neutralizing TNF-alpha (tumor necrosis factor alpha), a protein that plays a central role in the inflammatory response of autoimmune diseases such as rheumatoid arthritis. HUMIRA is already used by one million patients in over one hundred countries.

AbbVie, Eisai and EA Pharma continue to promote and provide information on the proper use of HUMIRA while making further contributions to improve the quality of life of patients.

(1) HUMIRA for Subcutaneous Injection 40 mg Syringe 0.4 mL and HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL

About HUMIRA

HUMIRA is a fully human anti-TNF-alpha monoclonal antibody formulation. In Japan, it is approved for the indications of "the treatment of rheumatoid arthritis (including inhibition of the progression of structural damage), the treatment of plaque psoriasis, arthritic psoriasis, pustular psoriasis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis*, intestinal Behcet's disease, and non-infectious uveitis, posterior uveitis or panuveitis, induction and maintenance therapy for moderate to severely active Crohn's disease (limited to patients who have had an inadequate response to conventional therapy), and treatment of moderate to severe ulcerative colitis (limited to patients who have had an inadequate response to conventional therapy ).

*HUMIRA for Subcutaneous Injection 80 mg Syringe 0.8 mL and HUMIRA for Subcutaneous Injection 80 mg Pen 0.8 mL are yet to be approved for this indication.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com.

About EA Pharma

EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd. for gastrointestinal disease area, was established in April 2016 by integration of the gastrointestinal business unit with more than 60 years' history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma is a gastrointestinal specialty pharma with a full value chain covering R&D, logistics and sales & marketing. For more information on EA Pharma Co., Ltd., please see www.eapharma.co.jp/en.

About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120

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