Underserved Rheumatic Diseases: Areas of Opportunity is a new study from Decision Resources, Inc., that evaluates drug development opportunities for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and Sjogren's syndrome (SS), three systemic, autoimmune diseases that are medically underserved and share numerous unmet needs.
Given the current scarcity of satisfactory therapeutic options -- particularly for SSc and SS -- any novel therapy developed specifically for one of these indications is likely to achieve some degree of market penetration. Furthermore, regulatory agencies may encourage research and development by granting fast-track new drug application (NDA) designation and orphan drug status to agents developed for these diseases. For therapies that prove to be effective, these three disease populations could support agents that are relatively high-priced.
Significant therapeutic advances are within reach as a result of an improved understanding of the basic mechanisms of autoimmune disease. Of the therapies in development, the most intriguing for SLE are costimulatory blockers that induce B-cell and T-cell anergy in the immune system. For SSc, the most advanced investigational therapy is relaxin, a heterodimer protein that is naturally secreted by the corpus luteum and placenta during pregnancy. Connetics Corporation is developing a recombinant form of human relaxin (ConXn), which is in Phase III U.S. trials, and the FDA has granted the agent orphan drug status. The first drugs developed specifically for SS are the muscarinic receptor agonists pilocarpine (MGI Pharma's Salagen) and cevimeline (SnowBrand Pharmaceuticals / Daiichi's Evoxac). These drugs are essentially symptomatic agents designed to increase salivary gland stimulation and relieve the common symptom of dryness associated with SS.
We estimate that sales of prescription drugs used to treat SLE, SSc, and SS totaled nearly $124 million in 1999. The combined market for the three indications will experience annual growth of 10.3% between 1999 and 2009. In 1999, SLE and SSc each contributed slightly less than 25% of combined sales, while SS contributed 53%. By 2009, the close of our study period, this dynamic will shift significantly, with the proportions closer to 12%, 23%, and 65%, respectively. We expect that the total market for the three indications will reach $331.2 million in 2009.
Underserved Rheumatic Diseases: Areas of Opportunity is part of the Immune and Inflammatory Disorders portfolio, one of six Pharmacor services that evaluate the commercial potential of drugs in research and development.
Decision Resources, Inc., is a world leader in pharmaceutical research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. Founded as a subsidiary of Arthur D. Little, Inc., the company has provided strategic information services for 30 years.
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SOURCE: Decision Resources, Inc.
Contact: Frank Sama of Decision Resources, 781-487-3753, or