SEATTLE -- Corixa Corporation, a developer of immunotherapeutics, announced that the Committee For Medicinal Products for Human Use (CHMP) the scientific body of the European Medicines Evaluation Agency (EMEA), has issued a positive opinion for Fendrix(R), GlaxoSmithKline Biologicals' (GSK Bio) vaccine for the prevention of hepatitis B in specific high-risk groups. Fendrix is a novel vaccine, containing Corixa's MPL(R) adjuvant, which is designed to help prevent infection from hepatitis B in specific high-risk groups such as pre-haemodialysis and haemodialysis patients. This positive opinion represents an important step in the continuing commercial development of Corixa's MPL adjuvant, which is included in several late stage GSK Bio specific vaccine product candidates.
The opinions of the CHMP generally serve as the basis for European Commission approvals. European Commission approvals are typically issued three months after the CHMP opinions are issued. However, Fendrix is not yet approved.
"We are pleased to announce today's progress toward commercialization of our MPL adjuvant," said Steven Gillis, PhD, chairman and chief executive officer of Corixa. "Given that MPL adjuvant is a component of several additional GSK Bio 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."
Adjuvants are formulated compounds or additives that help to boost the body's immune response when combined with vaccine antigens. In addition to GSK Biologicals' Fendrix vaccine, MPL is present in a number of GSK Bio vaccines now in late stage clinical development, including a vaccine under investigation for the prevention of cervical cancer, and another vaccine under investigation for the prevention of genital herpes.
Source: Corixa Corp.