Wockhardt said 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 bacteraemia.
The two antibiotics EMROK (intravenous infusion) and EMROK (Oral- tablet) were approved based on the Phase 3 study involving 500 patients in 40 centres across India.
"Wockhardt becomes the first domestic drug maker to get approval for novel antibiotic drugs discovered, developed and manufactured in India," Murtaza Khorakiwala, MD of Wockhardt, said during a conference call.
The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).
Khorakiwala said the company would be launching the two drugs in the next few months in India and later in China and emerging markets.
Khorakiwala said the company would be marketing the drug using its own distribution network in India.
Wockhardt has been working on drug discovery for two decades with a focus on antibiotic research. The company has a pipeline of five new antibiotics under various stages of development, of which it got approval for two in India.
Khorakiwala said there had not been a single new antibiotic launch in India whereas the resistance to existing antibiotics is growing.
The company said EMROK had a better safety profile over other antibiotics vancomycin, leptomycin and linezolid that have certain side effects.
The size of the Indian antibiotic market is around Rs 16,000 Crore, growing at 7 percent. It is one of the largest therapeutic segment, with a 12 percent market share of the Indian pharmaceutical market.
"By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over the currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality,” said Habil Khorakiwala, Founder Chairman, Wockhardt Group.
AMR is a major public health problem globally. India carries one of the largest burdens of drug-resistant pathogens worldwide. Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development.
Two million deaths are projected to occur in India due to AMR by the year 20502. In 2017, the World Health Organisation (WHO) listed Methicillin resistant S. aureus (MRSA) as a 'high' priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings.
In 2018, a national study conducted by the Indian Council of Medical Research (ICMR) and Anti-microbial resistance surveillance network (AMRSN) group highlighted the high prevalence of 38.6 percent of MRSA in India. A recent Indian study reports that one in six patients infected with multidrug-resistant Gram positive infections die in intensive care units.