Sequella, Inc., a US-based biotechnology company, is planning to enter Indian market with their new TB products.
The products under development include — second-generation ethambutol; therapeutic TB DNA vaccine; peptide-based vaccine; Bronx Box (A device that can confirm TB diagnosis and determine drug sensitivity of the patient isolate in 2 days); transdermal patch (A band-aid like patch that can detect active TB). Phase III clinical trials of the products including the transdermal patch test began in February 2005.
"We will, I am sure, have several corporate partners in India for the marketing and sales of our new TB products. We are still in the clinical development phase, so it will be a while before we have those relationships settled," Carol A. Nacy, CEO, Sequella, Inc. informed Pharmabiz. We always want to partner with companies on the upswing, so look forward to future discussions in India as our new TB technologies complete their development process, she added. However, she refused to divulge further details.
Having spent some time in India over the last 10 years, it is clear that there is a market for new and more effective and efficient TB products here, and everywhere. However, India does have a significant portion of the overall TB burden of the world (20%), so that translates to several million newly diagnosed TB cases every year, she said.
Between 60% and 90% of people with TB are diagnosed and treated in the private sector, and they pay out of their pocket for care. At the moment, it takes upto 6 months to diagnose and identify a case of TB with techniques that are 100 years old and a therapeutic regimen which comprises at least 6 months with 4 different drugs, all of which were discovered 40-60 years ago, she noted.
The problem in stimulating new product development for TB is that it is incorrectly characterized as a disease of the poor with disasterous consequences for the very patients the global health authorities would like to help. If there is no perceived market, then there will be no investment in research and development of new drugs or diagnostics, since the process is long and costly for each new product registered, she said.
Tuberculosis is the leading single-agent infectious disease killer in the world, as well as being the leading cause of death for people infected with HIV. In the 1990s alone, there were 30 million estimated deaths due to TB, and it is predicted that TB will kill 70-90 million people in the next three decades without new tools to fight the disease. According to the World Health Organization and Harvard School of Public Health, approximately $4 billion is spent every year on TB control, of which $2.8 billion is spent by developed countries such as the US.
The founders of Sequella, Inc. also incorporated the Sequella Global Tuberculosis Foundation, a non-profit organization complementary to Sequella, Inc. that bridges the gap between basic research and product development. The Foundation helps the TB research community to identify potential products from their basic research funded by the US-based National Institute of Health (NIH).