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CDSCO has given its nod for a new generation oral antibiotic Nafithromycin, which is used to treat community-acquired bacterial pneumonia (CABP) in adults. The approval follows a favourable recommendation for manufacture and marketing of Nafithromycin from the subject expert committee (SEC) of CDSCO, the company said in an exchange filing.
Over 15 years, Miqnaf underwent extensive non-clinical and clinical studies, which include human trials in the US, Europe, South Africa and India.
Miqnaf is an ultra-short, once-a-day, 3-day treatment for CABP including those caused by multi-drug resistant (MDR) pathogens.
CABP affects millions of people worldwide with 23% of the global disease burden borne by India. CABP and other respiratory infections could be caused by several bacterial pathogens, the dominant being S pneumoniae and H influenzae and also by atypical respiratory pathogens such as Mycoplasma, Chlaymydia and Legionella, the company said.
Wockhardt plans to launch Miqnaf in the Indian market in the coming few months.
Speaking to CNBC-TV18, Wockhardt Chairperson Habil F Khorakiwala said that he expect about 65-70% market share over the next 4-5 years for Miqnaf drug. The market potential for Miqnaf is around ₹4,000–5,000 crore in India.
Further, Khorakiwala said that he expects an approval in Saudi Arabia for Miqnaf. With Miqnaf, the company’s revenue potential is ₹500-700 crore in the next 2-3 years.
Shares of Wockhardt are currently trading 6% higher at ₹1,529.
The stock has risen over 200% in 2024, which was the best calendar year for the company since 2012, during which the stock had gained 469%. The shares had risen 90% as well in 2023.
