India indigenously develops new antibiotic for drug-resistant pneumonia
In a groundbreaking step for India’s biotechnology sector, Wockhardt Ltd, the Maharashtra-based pharmaceutical company has reached scientific completion of the first indigenously developed antibiotic Nafithromycin (trade name Miqnaf) against multi drug-resistant isolates.
The novel antibiotic is discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults.
In an event organised by the Department of Biotechnology, India and Biotechnology Industry Research Assistance Council (BIRAC) on November 20 in New Delhi, the drug was ‘soft launched’ in the presence of Dr Jitendra Singh, Union Minister of State for science and technology.
“Drug-resistant pneumonia is a condition responsible for over two million deaths globally each year. India, which bears 23 per cent of the world’s community pneumonia burden, faces challenges with existing treatments, including widespread resistance to drugs like azithromycin,” mentioned the press release by the Union Ministry of Science & Technology on November 20, 2024.
BIRAC gave Rs 8 crore (out of the total cost of Rs 500 crore) to Wockhardt for phase 3 clinical trials of Nafithromycin and also provided technical support through expert committees.
Dr Habil Khorakiwala, founder-chairman, Wockhardt highlighted the significance of Miqnaf in his presentation. It is an oral drug developed with the aim of tackling community respiratory infections. No new antibiotic has been developed in this segment in the last 30 years globally.
The drug is 10 times more potent and provides eight times higher lung exposure than azithromycin. It has to be taken once a day for three days, Khorakiwala noted. Nafithromycin also boasts of superior safety and tolerability and even has a clinical cure rate of 96.7 per cent.
The development of Nafithromycin represents 14 years of dedicated research and an investment of Rs 500 crore, with clinical trials spanning the United States, Europe and India, mentioned the press release.
“This achievement not only marks a significant milestone in our fight against antimicrobial resistance (AMR) but also paves the way for future breakthroughs in the development of life-saving medicines. We are committed to improving lives and building a healthier, more resilient future for all,” said Dr Jitendra Singh in the press release expressing optimism about India’s future in the battle against AMR. “The soft launch of Nafithromycin serves as a powerful reminder of India’s potential to lead the world in tackling one of the most pressing health threats of our time,” he added.
AMR occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines.
Last year, researchers from Delhi-based think tank Centre for Science and Environment (CSE) wrote about the current status of the global antibiotic pipeline in the article A Developing Crisis in the magazine Down To Earth. In the assessment, the researchers had highlighted how the big pharmaceutical companies, which were once the pioneers of antibiotic development, have exited this space and small companies including Indian companies are picking up the slack.
Additionally, CSE researchers had also conducted a webinar with small scale antibiotic developers in India including representatives from Wockhardt Limited, Bugworks Research India Pvt Ltd and BIRAC to better understand the challenges they face while developing antibiotics and the way forward.