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Miqnaf is an ultra-short course, once-a-day, 3-day treatment for CABP, including those caused by multi-drug-resistant (MDR) pathogens. The approval follows a favourable recommendation for manufacture and marketing of nafithromycin from the Subject Expert Committee (SEC) of CDSCO.
Over 15 years, Miqnaf underwent extensive non-clinical and clinical studies, including human trials in the US, Europe, South Africa, and India. It represents a new macrolide-based treatment for CABP in India after a gap of nearly 30 years.
Moreover, the ultra-short course regimen is said to enhance patients’ compliance with treatment, resulting in favourable outcomes. In India, antibiotic resistance is a burning issue, including in community pneumonia cases.
A key strength of Miqnaf is its ability to target a wide range of respiratory infections, including bacteria resistant to common antibiotics like azithromycin and amoxicillin/clavulanate, making it a strong single-treatment option for pneumonia.
CABP affects millions of people worldwide, with 23% of the global disease burden borne by India. Several bacterial pathogens could cause CABP and other respiratory infections, the dominant being S. pneumoniae and H. influenzae and atypical respiratory pathogens such as Mycoplasma, Chlamydia, and Legionella.
Mumbai-based Wockhardt is a research-based global pharmaceutical and biotech company. Employing around ~2600 people and 27 nationalities, it has a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia, and many other countries. It has manufacturing and research facilities in India and the UK and a manufacturing facility in Ireland. Around 78% of its global revenues are coming from international businesses.
The company reported consolidated net loss of Rs 16 crore in Q2 FY25 as against net loss of Rs 35 crore posted in Q2 FY24. Net sales rose 7.43% year on year to Rs 809 crore in Q2 FY25.
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