Drug controller general of India V.G. Somani has approved Wockhardt’s new antibiotic EMROK in intravenous (IV) and oral dosage forms, which will be used to treat superbug infections, the company announced on Thursday.
The Indian drug regulator’s approval for EMROK oral and IV dosages is the first for an Indian company, the company said in an exchange filing.
The company expects the new drugs to become the first choice of treatment for superbug infections in hospitals, and achieve cumulative annual sales of ₹100 crore in the next 18-24 months, Wockhardt managing director Murtaza Khorakiwala said in a conference call on Thursday.
The total size of the antibiotic market is ₹16,000 crore in terms of annual sales, and accounts for around 12% of the Indian pharmaceutical market.
News of the approval buoyed investor sentiment. At 1.10 pm, shares of Wockhardt were up 6% at ₹274.50 on the National Stock Exchange.
The drugs will target drug-resistant bacteria like methicillin resistant staphylococcus aureus (MRSA), and will be used to treat acute bacterial skin and skin structure infections, including diabetic foot infections and concurrent bacteraemia, the company said.
“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” Wockhardt founder chairman Habil Khorakiwala was quoted as saying in a release.
Approval for the drug is significant because anti-microbial resistance (AMR), a term used for bacteria developing resistance to antibiotics, is one of the major health problems globally. India carries one of the largest burdens of drug‑resistant pathogens in the world. About 2 million deaths are projected to occur in India due to AMR by the year 2050, Wockhardt said quoting a research report.
The World Health Organisation (WHO) in 2017 listed MRSA as a ‘high’ priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings.
Wockhardt said that EMROK is the first anti-MRSA agent after a gap of around 14 years.