Wockhardt becomes the first Indian company to get a boost from novel antibiotics nod

Wockhardt announced on January 16, that the Drug Controller General of India (DCGI) had approved two new antibiotics for skin and other drug-resistant infections including diabetic foot infections and concurrent bacteremia. The managing director Khorakiwala said the company would be launching the two drugs in the next few months in India and marketing the drug using its distribution network, and later in China and emerging markets.

The two antibiotics EMROK (Intravenous infusion) and EMROK (Oral-tablet) were approved based on phase 3 clinical trial study involving 500 patients in 40 centres across India. The new drug is going to target superbugs like Methicillin-resistant Staphylococcus aureus (MRSA), which has become resistant to other molecules as well. Wockhardt's new drugs are hospital antibiotics and will be used primarily through the hospital channel for treating critical infections. The firm has a pipeline of three more antibiotic candidates for which, it is planning to start clinical trials soon and also said the new drugs were a result of 20 years of research. While Wockhardt would need more funds to be pumped into R&D as it develops its antibiotic pipeline, the company has a huge debt to service.

Antimicrobial research is a major public health problem globally. India carries one of the largest burden of drug-resistant pathogens worldwide. Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalization. Wockhardt claims that the current antibiotics available in this segment have multiple side effects like potential kidney damage and bone marrow damage. "This limits their use in critically ill patients," Khorakiwala said adding that Emrok and Emrok O have a better safety profile. It is also one of the most scientifically profiled molecules in this space

The World Health Organisation (WHO) in 2017 has listed MRSA as a 'high' priority pathogen due to a high prevalence of resistance, mortality rate, and a burden on community and health care settings. In 2018, a national study conducted by the Indian Council of Medical Research (ICMR) and Anti-microbial resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6 percent of MRSA in India.