HUMIRA® Subcutaneous Injection 40mg Syringe 0.8mL Now Available for the Treatment of Rheumatoid Arthritis
Abbott Japan Co., Ltd.
Eisai Co., Ltd.
On June 17, 2008, Abbott Japan Co., Ltd. (Pharmaceutical Products Group in Tokyo, President: Glenn S. Warner) and Eisai Co., Ltd. (Headquarters in Tokyo, President and CEO: Haruo Naito) announced that HUMIRA® subcutaneous injection 40mg Syringe 0.8mL (referred to as HUMIRA hereinafter) will be available for the treatment of rheumatoid arthritis from June 18, 2008.
HUMIRA® received approval for manufacturing and distribution in Japan on April 16, 2008, and was listed in the National Health Insurance drug price list on June 13, 2008. After its launch, Abbott and Eisai will take a one-brand, one-channel and two-promotion scheme to ensure provision of information on proper use of HUMIRA®. Both Abbott and Eisai will provide specialist medical representatives (MRs), and Abbott will cooperate with Eisai's hospital MRs. The two companies will conduct postmarketing surveillance in patients receiving HUMIRA® during a certain period of time after launching to promote the effective and safe use of HUMIRA®.
HUMIRA® is the world's first fully-human 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 including rheumatoid arthritis. HUMIRA® is administered as subcutaneous injections every other week, and has been demonstrated to alleviate signs and symptoms, improve the quality of life (QOL), and prevent the progression of joint destruction in patients with rheumatoid arthritis.
On June 18, Abbott and Eisai will open the HUMIRA® Information Net website to provide information on HUMIRA and rheumatoid arthritis for healthcare professionals and patients with rheumatoid arthritis and their families (http://www.e-humira.jp).
Abbott has submitted an application for approval of HUMIRA® for psoriasis. The two companies are now jointly conducting phase II/III studies in patients with Crohn's disease, and are also developing HUMIRA® in Japan for ankylosing spondylitis, juvenile rheumatoid arthritis, and ulcerative colitis.
[See the reference information for glossaries, Eisai's commitment to antibody drugs, and Abbott's commitment to immunology]
The tumor necrosis factors (TNFs) are a group of cytokines (i.e., substances mediating cell-cell interactions) mediating intercellular communication that have been found to damage tumor cells. TNF is produced by many types of cells, including macrophages, lymphocytes, and vascular endothelial cells, and is known to cause and enhance inflammatory responses and to activate inflammatory cells.
2) Monoclonal antibody
A monoclonal antibody is a protein produced from clones of a single antibody-producing cell (called monoclone). Using the monoclonal antibody technique, manufacturers can obtain a homologous population of antibody molecules identical in amino acid sequence and other characteristics.
3) Rheumatoid arthritis (RA)
Rheumatoid arthritis is an autoimmune disease in which joints are inflamed, which may lead to damage to the interior of joints and the surrounding bone. The joints most commonly affected early in the disease are the smaller joints of the fingers, feet, and wrists. The elbows, knees, ankles, and hips can also be affected. Although there is no cure for RA, people continue to seek treatments that not only alleviate the pain and inflammation associated with it but also slow disease progression, and thereby inhibit the joint damage that can hinder performance of daily activities. It is estimated that over 5 million patients in Japan, the United States, and Europe, mostly between the ages of 22 and 55, are receiving antirheumatic drugs for the treatment of rheumatoid arthritis.
2. About HUMIRA®
HUMIRA® resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-), a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases. To date, HUMIRA® has been approved in 75 countries, and more than 250,000 people worldwide are currently being treated with HUMIRA® (as of April 2008). Clinical trials are also underway for evaluation of the potential of HUMIRA® in treating immune-mediated diseases beyond its currently approved indications.
3. Eisai's Commitment to Antibody Drugs
Eisai, which is strong in low-molecular-weight drugs, is aggressively addressing biologics. In April 2007, Eisai acquired Morphotek, Inc., a bio-venture specialized in research and development of antibody drugs in the United States, and is now involved in creation of antibody drugs for the treatment of cancer, rheumatoid arthritis, and infections using Morphotek's unique technologies such as Human Morphodoma® and Libradoma™. In addition, Eisai is investigating immunotherapy for Alzheimer disease in cooperation with BioArctic Neuroscience Inc. in Sweden, and is developing and marketing a fully-human anti-TNF monoclonal antibody for the treatment of immune/inflammatory diseases including rheumatoid arthritis in Japan in cooperation with Abbott Japan. Eisai is thus committed to improving the QOL of patients and their families by producing antibody drugs.
4. Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch Center, founded in 1989 in Worcester, Mass., United States, is a world-class discovery and basic research facility committed to finding new treatments for immune-mediated diseases. More information about HUMIRA®, including full prescribing information and Medication Guide, is available on the Web site www.humira.com or in the United States by calling Abbott Medical Information at 1-800-633-9110 (English information only).
5. About Abbott
Abbott, headquartered in Abbott Park, Illinois (near Chicago) is a global, broad-based heath care company devoted to research and development of new drugs as well as research into, development, manufacturing, marketing, and distribution of pharmaceutical/medical products, nutritional products, medical devices, medical instruments, and diagnostics. It employs more than 68,000 people and markets its products in more than 130 countries.
In Japan, the 2,400 people of Abbott are devoted to the manufacture, development, distribution, and marketing of drugs and the distribution and marketing of pharmaceutical/medical products, nutritional products, medical devices/instruments, and diagnostics. Abbott's main offices in Japan are located in Tokyo, Fukui, and Chiba.