Indias Drug Warriors

2015
Indian companies have joined the global hunt to discover new antibiotics. The good news is that they are steadily moving ahead. It is turning out to be a serious health scare. With bacteria fast developing resistance to existing antibiotics, we may soon reach a stage where a simple bruise may prove fatal. What is making things worse is that no new antibiotic has been discovered for bacteria that have developed resistance to some currently available antibiotics. 
This seems set to change. In India, a bunch of bravehearts, knowing well that drug discovery is 'high risk, high reward' game, is doing extensive research to discover the next big antibiotic. They know that there are no clear timelines for drug discoveries. They know that the failure rate is high. But they are passionate about their work. If things go as planned, a new antibiotic for multidrug-resistant infections based on a made-in-India compound will hit the market by 2023.
"We have four programmes and hope to reach proof-of-concept in the target population by 2018. We could then, it not earlier, out-license the molecule to a global company for milestone payments and royalties as it takes it up for further development," says Radha Rangarajan, the CEO and co-founder of the Hyderabad-based Vitas Pharma. Such out-licensing is a common practice in the pharmaceutical industry, as further development of a molecule, till the time it hits the market, is a very costly affair. The risk of failure, too, is high.
The nine-member Vitas is working on developing the next-generation antibiotic for multidrug-resistant infections. These infections kill lakhs of people globally. The problem - a result of misuse of antibiotics - is so acute that even simple infections that were easily treatable in the past are becoming life-threatening.
•    Vitas has got seed funding from the Indian Angel Network and two grants from the Biotechnology Industrial Research Assistance Council. It also has a research collaboration with Biocon. The drug is at the toxicology study stage (in which scientists look at the adverse effects in living organisms), though Rangarajan is hopeful that next year the company will be able to file for an IND (investigational new drug) application with the US Food and Drug Administration (USFDA), which could give the product QIDP status. QIDP, or Qualified Infectious Disease Product, is a fast-track approval programme of the USFDA for new antibiotics. "Radha and her team have been working a lot in this space. I extended my support as it is important for India to do something in this area," says Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw.
•    'We have four programmes and hope to reach the proof-ofconcept in humans in three years', says Radha Rangarajan, CEO, Vitas Pharma
•    In Bangalore, Shaw's home town, a 15-people team of Bugworks has been working on drug-resistant and hospital-acquired infections since January 2014. "Our product is at an early stage but the results look exciting, though we are still some time away before we can say that we have a strong chemical compound," says CEO Anand Anandkumar. "By 2019, we hope to reach the stage of early proof-of-concept in humans," he says. He says they are also working on bio films, a chemical for coating biomedical devices so that these do not catch infections and spread them on to patients.
•    There is no fixed timeline for approval as it depends upon the product and the USFDA policy for the therapy segment it belongs to. Though the average time taken for drug discovery is 10 years (See It's a Long Road), in case of new antibiotics, after Phase II, it could take three to five years (three for clinical development and two for approvals), as are under the QIDP programme.
•    What makes these developments important is that almost no big cash-rich Indian pharmaceutical company is investing in basic research in this field. "It is difficult for generic companies, with 24 per cent EBITDA margins, unlike the 40-50 per cent margins that innovator companies earn. On top of that, the government wants to impose price control," says a senior executive at a leading pharmaceutical company. Even worldwide, few companies are working on antibiotics, as they are not as profitable as, say, drugs for cancer and diabetes. This is because a course of antibiotics lasts just five days while medicines for diabetes and hypertension have to be usually consumed for life and, therefore, turn in more profits. The total global market for antibiotics is estimated to be worth $40 billion.
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•    There is a need for mission-oriented research in antibiotics with stronger commitment from the pharmaceutical sector. No matter what the costs are, it is important for humanities survival that companies succeed costs of all failures against one success. But I still think you need $500 million from inception to the time the drug is fully out in society," says Anandkumar. Rangarajan of Vitas Pharma says "the cost of early clinical development varies depending on whether it is a big pharmaceutical company or a small biotech player. For antibacterials, this work can be done for less than $10 million depending on where the trials are conducted.