In a first, pharma major Wockhardt has got the nod from the Drug Controller General of India (DCGI) for two new antibiotic medicines, which it plans to launch in the Indian market over the next few months. In the last 15 years, there has been no new antibiotic launch in this category (gram-positive bacterial infections) in India.
Wockhardt now plans to take this new drug to emerging markets and is eyeing the Chinese market too through partnerships. China is the largest market for antibiotics globally in terms of volumes.
The firm has a pipeline of three more antibiotic candidates for which, it is planning to start clinical trials soon. It said the new drugs were a result of 20 years of research.
The new drug will target superbug MRSA (Methicillin-resistant Staphylococcus aureus), which is a leading cause of rising antimicrobial resistance (AMR). At present, AMR is a major public health concern 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 hospitalisation. Two million deaths are projected to occur in India due to AMR by the year 2050. Globally, this is likely to touch 10 mn deaths by 2050.
Wockhardt’s managing director Murtaza Khorakiwala said that the company thus saw a huge unmet medical need in this segment.
“Wockhardt becomes the first domestic drug maker to get approval for novel antibiotic drugs discovered, developed and manufactured in India,” he added.
The company’s stock prices soared in morning trade after the announcement came in. It was trading at Rs 274.5 a piece on the BSE in the afternoon, up 6 per cent.
DCGI has approved two new antibiotics – Emrok (injectable) and Emrok O (oral) – used for acute bacterial skin and skin structure infections including diabetic foot infections. The approval is based on phase 3 clinical study involving 500 patients in 40 centres across India.
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 size of Indian Antibiotic market is approximately Rs 16,000 crore, growing at 7 per cent and is one of the largest therapeutic segment, with a 12 per cent market share of the Indian Pharmaceutical Market.
The World Health Organisation (WHO) in 2017 has listed MRSA as a ‘high’ priority pathogen due to high prevalence of resistance, mortality rate, 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 per cent of MRSA in India. A recent Indian study reports that 1 in 6 patients infected with multidrug-resistant gram-positive infections die in intensive care units.
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