Abstract
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.
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