Stakeholder Opinions: Biologics in Infectious Diseases Well defined target populations are key to commercial success

Introduction Antibody-based agents represent a novel approach to the treatment and prophylaxis of infectious diseases. In recent years, considerable interest has been expressed in their further development, driven by advances in technology that improve manufacturing cost and tolerability: fully human antibody reagents avoid the toxicities associated with traditional human- or animal-derived serum therapy. Scope An overview of the past, current and emerging technologies for biologics as well as obstacles faced in development. Discussion of antibody products in development for several viral infections and their probable use. An assessment of pipeline antibody agents targeting important bacterial and fungal nosocomial pathogens. A review of the key unmet needs within bacterial, viral and fungal infections along with an outline of the commercial outlook for antibody agents. Highlights Antibodies offer several advantages over conventional anti-infectives and vaccines but their cost and mode of administration limits their use in certain areas. A high unmet need and defined target groups are required to gain commercial success. Pipeline products fulfilling these criteria have a greater chance of commercial and scientific success. Accounting for the majority of nosocomial infections, MRSA is the most popular target for antibody development. Despite concerns over resistance there are still several antibiotics that can treat multi-drug resistant S.aureus, reducing the need for antibody-based therapeutics. The greater need lies in treatment of Pseudomonas and fungal infections. For most viral infections, conventional therapies are able to control disease progression effectively. In HIV and HCV the real need is for a cure or preventative measure but the majority of pipeline products are being developed for treatment of these infections. Reasons to Purchase Identify the key antibody products in development for bacterial, viral and fungal infections. Examine the remaining and emerging unmet needs in the infectious diseases market and identify opportunities for antibody product development. Gain an overview of the commercial outlook for antibody based products and their likely positioning in the prophylaxis and treatment of infections.

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