INFLAMMATORY DIRECTIONS: Strategies for Six Diseases with Unmet Needs
Author: Mark C. Via
The pharmaceutical industry is exhaustively exploring novel targets in the search for new drugs to treat inflammatory diseases. Delving in-depth into these efforts, this report provides:
- An analysis of six diseases: rheumatoid arthritis, inflammatory bowel disease, psoriasis, lupus, multiple sclerosis, and asthma
- An assessment of existing drug therapies for these diseases
- Discussion of pharmacological R&D strategies being employed by the industry in developing both biological and small-molecule agents for these diseases
- Review of the approximately 200 compounds in clinical development and assessment of particularly noteworthy drug candidates for these diseases
Autoimmune disorders and asthma have drawn a great deal of attention from the pharmaceutical industry. The most successful new approach to treating inflammatory diseases in the last decade has addressed the pro-inflammatory role of cytokines, notably TNF-alpha, in these types of conditions. Three TNF-alpha blockers—Enbrel (etanercept), Remicade (infliximab), and Humira (adalimumab)—are now marketed for treating a range of autoimmune diseases, and they enjoy true blockbuster status, with aggregate sales topping $9 billion in 2006.
Nevertheless, the door remains open for improved therapeutics. Some patients do not respond to the TNF-alpha inhibitors; the effectiveness of the agents depends on long-term, even lifelong, administration; and they have been linked to tuberculosis, lymphoma, and other adverse effects.
Several new biological agents have begun to carve their own niches in the massive edifice of the TNF-alpha blockers. Orencia (abatacept), a T-cell co-stimulation modulator, was approved for the treatment of rheumatoid arthritis in 2005; Rituxan (rituximab), an anti-CD20 antibody, for rheumatoid arthritis in 2006; and Tysabri (natalizumab), an adhesion molecule blocker, for multiple sclerosis in 2006 and Crohn’s disease in 2008.
A recurrent theme in discussions of treatment options for autoimmune diseases is the inadequacy of the standard of care. Management and pharmacotherapy are seeing only incremental improvements. Patients with asthma, an allergic disease, tend to fare well with the drugs currently available, though better treatment options with less potential for side effects are needed.
The complexity of the immune system provides both opportunity and challenge for the pharmaceutical industry. There is a seemingly endless list of cytokines, receptors, and enzymes that can be disrupted in patients with autoimmune and inflammatory diseases, and the sheer number of options leaves plenty of chances for companies—large established players and specialized newcomers alike—to carve out niches. On the other hand, the transition from brainstorm to marketed drug is fraught with pitfalls. Targeting a single receptor or protein often means being foiled by the immune system’s redundancy, while cutting too wide a swath through the system can result in unexpected side effects.
Inflammatory Directions: Strategies for Six Diseases with Unmet Needs is a valuable resource for anyone involved in the discovery, research, development, or marketing of inflammatory therapeutics.
About the Author
Mark C. Via, an editor at CTB International Publishing, has more than 14 years of experience writing and editing for pharmaceutical trade publications. He holds a BA in history from Williams College. Mr. Via has authored previous Cambridge Healthtech reports, including Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment (www.insightpharmareports.com/reports/2007/88_Monoclonal_Antibodies/overview.asp).