Near-Term Market

Our drug candidates have broad market potential with applications in tuberculosis, candidiasis, SARS, bacterial pneumonia, and a number of other infectious diseases.

Tuberculosis

A highly contagious infectious disease, TB is caused by the bacterium Mycobacterium tuberculosis.  TB is the leading cause of worldwide deaths that result from a single-agent infectious disease, and as a result was declared a global health crisis by the World Health Organization (WHO) in 1993.  The WHO estimates that nearly one-third of the world’s population is currently infected with TB, and projects that 60 to 90 million people will die over the next three decades if there is not a dramatic shift in diagnosis and treatment.  As documented by the WHO in 2006, there were 8.9 million estimated new TB cases worldwide and 1.7 million deaths.  In the United States, there are an estimated 10 to 15 million people infected with TB, resulting in 14,000 to 15,000 active, infectious TB cases each year and between 300,000 and 430,000 latent TB cases treated prophylactically with drugs.

While it is not the Company’s intent or focus to develop diagnostic tools for all targeted indications, the diagnostics available in TB are so antiquated and inadequate that a more sensitive, specific diagnostic has the potential to greatly increase the market for new TB drugs by identifying more cases. The WHO reported that the primary diagnostic test used to confirm active TB is only 27% accurate; this means that the vast majority of those with TB remain undiagnosed and untreated, and continue to infect those around them.  To put this in perspective, if each new TB case came into contact with no more than 10 susceptible individuals prior to diagnosis, then up to 40 million new infections could occur per year.  (JAMA 2005; 293: p.2785)  Predictably, there has been a dramatic spike in incidence levels both in the United States and abroad due to this “diagnostic” problem. 

Each year, the world spends an estimated $10 billion on TB control; $3 billion of this is spent by established market economies.  The Sequella target market is the $1.5 billion spent on inadequate and antiquated clinical tools today.

Diagnosis

There is a significant need for improved TB diagnostic products that have greater sensitivity and specificity than current, outdated and nonspecific methods: 

• Tuberculin Skin Test
  The most commonly used test for latent TB infection in the U.S. is the tuberculin skin test (TST), also called the PPD or Mantoux skin test. The TST is not specific for TB and has a high false positive rate in many populations.
• AFB smear
  The acid-fast bacilli (AFB) smear is the standard test for diagnosing active TB. Roughly 50% of patients have a false-negative result, despite having active TB disease.
• AFB culture
  The sputum sample can also be cultured in order to confirm the presence of Mycobacteria as a method for absolute TB diagnosis, but it takes 12 weeks to obtain results. Culture identifies 60% of pulmonary TB patients.
• QuantiFERON-TB Gold
  The TB Gold In-tube method is an in vitro diagnostic test to aid in the detection of TB Mycobacteria infection. The assay measures Interferon-gamma (IFN-y) secreted from stimulated T-cells previously exposed to TB and is registered to confirm latent TB.
• Chest x-ray
  A chest x-ray lesion on the lungs can suggest TB disease, but cannot confirm it.

Treatment

Sequella TB product development programs are years ahead of large pharmaceutical discovery efforts. With the anticipated market launch of the Sequella Patch Test for active TB, the company has positioned itself to drive the development of more effective treatments to alleviate the global threat of TB.

The current recommended TB treatment regimen requires administration of four first-line TB drugs (Isoniazid, Rifampin, Pyrazinamide, and Ethambutol or Streptomycin) for a minimum of 6 to 9 months. These TB drugs were developed between 1944 and 1970. According to the Journal of the American Medical Association (JAMA): “New drugs are needed to treat TB because the current drug combination has significant disadvantages.” (JAMA 2005; 293: p.2705) There is a need for TB drugs that require shorter treatment duration; work effectively against strains of drug-resistant TB bacilli; deliver an improved side effects profile; and help address medication compliance issues.

Back to Top