Press Release

Abbott Japan Co., Ltd. (Pharmaceutical Products Group, Tokyo, President: Glenn S. Warner, “Abbott Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) today announced that they had submitted an application for approval for the treatment of ankylosing spondylitis as an additional indication for Humira® pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (generic name: adalimumab), a fully human monoclonal anti-TNF- antibody jointly developed by the two companies in Japan. If approved, ankylosing spondylitis will be the fourth indication for Humira, following rheumatoid arthritis (approved in April 2008), psoriasis vulgaris and psoriatic arthritis (filed for approval in September 2007), and Crohn's disease (filed for approval in September 2009).

Adalimumab is a monoclonal antibody that neutralizes the activity of tumor necrosis factor alpha (TNF-), a protein that plays a central role in inflammatory reactions in patients with autoimmune diseases. Abbott Japan obtained marketing authorization for Humira in Japan, while Eisai has approval to distribute the drug. The two companies are co-promoting Humira using a one-brand, one-channel, two- promotion mode.

In clinical studies in patients with active ankylosing spondylitis in Japan, Humira demonstrated excellent efficacy in improving the signs and symptoms of ankylosing spondylitis and tolerability equivalent to that observed in foreign studies.

Ankylosing spondylitis is characterized by joint pain and stiffness in the neck, lower back, and hips, as well as the hands and feet in some cases, followed by the development of fusion and rigidity of affected joints over time. There is no specific cure for this chronic inflammatory disease at this moment. In an effort to contribute to improving the quality of life (QOL) of patients with ankylosing spondylitis, Abbott Japan and Eisai will work in tandem to bring Humira as a new treatment option for them.

For more information:
http://www.eisai.co.jp/enews/enews200944.html