AstraZeneca Starts Major R&D Push in Biologics

AstraZeneca has an increased focus on biologics R&D, including antibody and vaccine discovery, development, production and commercialization, through its newly expanded subsidiary MedImmune.

AstraZeneca said MedImmune plans to file a biologics license application early in 2008 for its anti-respiratory syncytial virus drug candidate motavizumab, which has completed a pivotal Phase III clinical trial. It also is working on a vaccine to help prevent pandemic influenza and plans to file an application for FluMist (influenza virus vaccine live, intranasal) with the European Medicines Agency in 2008.

MedImmune has Phase I and II clinical trials under way for monoclonal antibodies to treat asthma, a Phase I study of an anti-interferon-alpha treatment for mild-to-moderate systemic lupus erythematosus, a Phase I clinical trial for a monoclonal antibody to treat rheumatoid arthritis, ongoing or planned clinical trials for three types of solid tumors, an ongoing Phase I clinical trial for a treatment for late-stage non-Hodgkin’s lymphoma and a Phase I trial of a treatment for certain leukemias and lymphomas.