SEATTLE--(BUSINESS WIRE)--May 12, 2003--Corixa Corporation today announced that its partner, GlaxoSmithKline Biologicals (GSK Bio) has filed for regulatory approval of Fendrix® with the European Agency for the Evaluation of Medicinal Products (EMEA). Fendrix is a novel vaccine designed to prevent infection from Hepatitis B in high-risk groups such as pre-haemodialysis and haemodialysis patients and it includes the GSK Bio hepatitis B antigen with the addition of Corixa's MPL® adjuvant. The Fendrix filing represents the first regulatory filing for approval of an infectious disease vaccine that contains Corixa's proprietary MPL adjuvant.
"We are pleased to announce today's progress toward commercialization of our MPL adjuvant," said Steven Gillis, Ph.D., chairman and chief executive officer of Corixa. "Given that MPL adjuvant is a component of several additional vaccines now in late stage clinical trials, we look forward to the growth of our adjuvant business and its potential contribution to Corixa's future product sales and royalty income."
About Corixa's Adjuvant Business and MPL
An adjuvant is a formulated compound or additive that, when combined with a vaccine, boosts the body's immune response to the antigen(s). Corixa's adjuvant technology is based on the fact that certain microbial products have long been recognized as potent immune system regulators and have been shown to induce a broad range of known cytokines, a class of substances that are produced by cells of the immune system and can affect the immune response. Modifications of these microbial products and their physical and biological delivery to the immune system can influence the way cytokines are expressed, as well as the recipient's own physiological responses. Such responses mimic the normal, protective responses that are initiated during microbial infection or injury. With its partners, Corixa is evaluating its adjuvants in adult and pediatric vaccines that are designed to be safe and more effective in protecting against a broad range of diseases.
Corixa's flagship adjuvant, MPL, is a derivative of the lipid A molecule found in gram-negative bacteria, one of the most potent immune system stimulants. Corixa also owns patented technology for extracting MPL adjuvant from bacterial cell walls. Several of Corixa's partners are evaluating MPL adjuvant in vaccines for development in allergy, cancer and infectious disease targets. MPL adjuvant has been administered to more than 12,000 patients in more than 33,000 doses as a vaccine adjuvant.
Under the terms of its existing agreement, Corixa granted GSK exclusive, worldwide rights to use MPL adjuvant in vaccines in a number of infectious disease fields, including hepatitis B. Under the agreement, GSK has agreed to pay Corixa transfer payments for supplies of MPL adjuvant and royalties on sales commercialization of vaccines developed under the agreement.
About Corixa
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system. Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a standalone basis. Corixa currently has multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials.
The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, with additional operations in Hamilton, Mont., and South San Francisco. For more information, visit Corixa's Web site at www.corixa.com. |
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