No new anti-TB molecule has been found in the last 40 years, as powerful pharma companies haven't given tuberculosis the importance. Hence, UK-based AstraZeneca Plc's gesture to invest around Rs 140 crore ($30 million) in India for TB drug research and development programme in addition to an earlier $10 million for an R&D facility is a welcome move. The new facility on the outskirts of Bangalore spans an area of 18,000 sq.m and currently has 67 scientists, which is expected to rise further. Sir Tom Mckillop, CEO, AstraZeneca Plc was in Bangalore for the inauguration of the state-of-art facility. Sir Mckillop during his interaction with the media answered some of questions posed by Nandita Vijay of Pharmabiz.com. Excerpts:
There has been a strong criticism that multinational companies are not bringing in new drugs for tropical diseases. In this context, how is that AstraZeneca happened to focus on TB research?
We have been providing innovative, effective medicines designed to fight diseases like cardiovascular, central nervous system, gastrointestinal, infection, oncology, pain management and respiratory. We focussed on tuberculosis only because of an unmet need in India and the developing world. We shortlisted tuberculosis after considering various other critical tropical diseases like malaria and filarial.
How do you view the potential for the new anti-TB drug?
All that I can say is that the potential beneficiaries of the new treatment for tuberculosis are amongst the poorest people in the world. At this stage I can only say that we will make tuberculosis drug in this lab which will be for the world's poorest countries at low prices in partnerships with governments and healthcare systems in order to ensure that patients can access the healthcare resources and drugs they need.
What made AstraZeneca select India as the location for TB research?
We are focussing on diseases of the developing world. India was selected for setting up the research and development facility because of its excellent quality of Indian scientists. We are investing in India because of its vibrant science and because we anticipate the adoption of meaningful intellectual property rights and total abidance to the Patent regime in 2005. We are fully aware of the quality of Indian researchers and so our investment here in Bangalore is definitely not based on cost because the cost of doing research is mainly a small part of the total global research and development efforts. The only reason for opting for India is the quality of scientists as we need creative scientists otherwise research in India is a waste of time.
The Bangalore centre will have access to AstraZeneca's global platform technologies and will work closely with scientists in the United Kingdom and the R&D facility in USA, where we are progressing a range of projects using both traditional and genomic based technologies to deliver innovative anti-bacterial agents to our pipe-line of new drugs for infection.
As a part of our global operating research and development policy we are open to strategic research partnerships with academic and commercial partners to complement in-house skills. In India we have active scientific collaborations with the Indian Institute of Science (IISc), Council of Scientific Industrial Research (CSIR) and the Department of Biotechnology (DBT), government of India.
How soon do you see the drug coming?
This is a very difficult disease and it will not be easy. We have made substantial progress and have got exciting leads. We hope to find a candidate drug (CD) for tuberculosis by 2006. May be by 2010 we may have the drug but that is ambitious. The candidate drug is the first milestone towards the discovery of a drug that is ready for toxicology study and animals tests. The clinical development of such candidate drugs to meet the need of patients in developing countries will only be achieved through constructive public/private partnerships with international agencies such as the World Health Organisation (WHO), the Global Alliance for TB development, International Donors, central and state governments.
Has AstraZeneca already identified any new compounds for TB?
We wish to find a compound that would reduce the therapy from the existing six-month treatment to less than four months. We are setting out to meet the challenges of finding new candidate drugs, agents that are better than the existing treatments which are active with shorter duration of therapy and active against latent diseases and resistance organisms.
We are also hoping that the new drug will have minimum side effects and also be compatible to HIV Mycobacterium tuberculosis cases. The strategy of our research is to go in for bioinformatics driven intracellular identification of novel pathways. The dynamics of this disease eradication programme is to eradicate the microbe from specific locations and reduce the treatment time. The new R&D centre in Bangalore is leading the effort to identify the new candidate drug. Our goal in India is to invest a new drug for tuberculosis, which currently affects two million people in India alone.
Most MNCs claim that for development of a new molecule there is no investment less than $500 million if that is true, would the commitment of $10 million be adequate?
We have invested around $40 million including the capital cost of around $10 million. But it will take more than $40 million to develop the drug.
We need a lot more investment. As of now we don't have a specific number. The development of a primary care drug usually costs around $1 billion. This is high-risk poker. Only one out of 10 cases end up becoming a success. We would be the pathfinders and no one has developed an anti TB drug for the last 40 years.
What about the cost of the new drug? Would it be affordable for India?
AstraZeneca hopes to make the tuberculosis drug available for the developing world at lowest prices in partnership with governments and healthcare systems in order to ensure that patients can access the healthcare resources and medicines. Such arrangements to offer differential prices must enjoy the full support of the government in the developing and developed world to prevent the diversion of the low cost drugs away from needy patients and pricing referencing. All countries must play their part in contributing additional resources to the treatment of this devastating disease. We hope to see a steep change in the allocation of resources to the treatment of TB from the G8 discussions this week devoted to the health in the developing countries.