Abbott and Eisai Submit Application for Approval of Humira® (Adalimumab), a Fully Human Monoclonal Anti-TNF- Antibody, for the Treatment of Crohn's Disease in Japan
Abbott Japan Co., Ltd.
Eisai Co., Ltd.
Abbott Japan Co., Ltd. (Pharmaceutical Products Group, Headquarters: Tokyo, President: Glenn S. Warner, “Abbott Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) announced today that they had submitted an application for approval of Crohn's disease as an additional indication for Humira® (adalimumab), a fully human monoclonal anti-TNF- antibody jointly developed by the two companies.
If approved, Crohn's disease will be the third indication for Humira, following rheumatoid arthritis (approved in April 2008) and psoriasis vulgaris and psoriatic arthritis (currently under review for approval).
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 approval to market and distribute Humira in Japan, while Eisai has approval to distribute the drug. The two companies are co-promoting Humira in one-brand, one-channel, two-promotion mode.
In the two placebo-controlled, double-blind comparative studies of Humira in patients with moderate or severe Crohn's disease performed in Japan to evaluate its efficacy in inducing and maintaining remission, Humira demonstrated excellent efficacy equivalent to that observed in foreign studies.
Crohn's disease is characterized by recurrent ulcers and inflammation in the gastrointestinal tract, and the number of patients with it is increasing. By providing Humira as a new treatment option for Crohn's disease, Abbott and Eisai will contribute to improving the quality of life (QOL) of patients.
[ Please refer to the following notes for a glossary of terms and information on Eisai and Abbott's commitment to immunology ]
< Notes for Editors >
1) Crohn's disease
Crohn's disease is a chronic autoimmune disease of unknown etiology that is characterized by inflammatory lesions mainly in the small and large intestine. The Ministry of Health, Labor, and Welfare has designated Crohn's disease as a specified disease for which financial support is provided for healthcare. Crohn's disease has become increasingly common during the last 10 years. As at the end of 2007, about 27,000 patients were registered (data from the Japan Intractable Disease Information Center).
Crohn's disease is more prevalent among males, with a male/female ratio of 2:1, and its most common age of onset is 20~29 years. Crohn's disease is characterized by intestinal stenosis, ileus, intestinal abscesses (collections of pus resulting from infection) and perianal fistulas (ulcers in the intestine that form tunnels to surrounding intestinal wall or skin). When signs and symptoms cannot be controlled with drug therapy, patients may require surgical treatment. Since patients with Crohn's disease often exhibit flare-ups and periods of remission, long-term treatment is required to prevent recrudescence (recurrence of gastrointestinal inflammation) and recurrence (occurrence of inflammation in a new region) even after achieving remission.
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.
3) 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.
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 80 countries and more than 370,000 people worldwide are currently being treated with it (as of August 2009). Clinical trials are also under way to evaluate the potential of HUMIRA in immune diseases other than those for which the drug is currently indicated.
3. Eisai's Commitment to Immunology
Eisai, which strength lies in low-molecular drugs, is aggressively addressing biologics. In April 2007, Eisai acquired Morphotek, Inc., in the U.S., a bio-venture specialized in the research and development of antibody drugs, and is now involved in the 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 humanized anti-human TNF- monoclonal antibody 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. About Abbott
Abbott, headquartered in Chicago, IL, 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. The company employs more than 68,000 people and markets its products in more than 130 countries.
In Japan, approximately 2,400 Abbott employees dedicated to the manufacturing, 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.
5. 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, is available on the following Web site http://www.e-humira.jp/ and www.HUMIRA.com.