Wockhardt shares jump over 9% to hit 52-week high as CDSO approves Miqnaf drug; all you need to know

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 the manufacture and marketing of Nafithromycin from the Subject Expert Committee (SEC) of CDSCO, the company said in its press release.

"Over >15 years, Miqnaf underwent extensive non-clinical and clinical studies, which include human trials in the US, Europe, South Africa, and India. It represents a new macrolide-based treatment for CABP in India almost after a gap of 30 years," the release added.

Moreover, the company added that the ultra-short course regimen enhances the patients’ compliance with treatment, resulting in favourable outcomes. In India, antibiotic resistance is a burning issue, including in community pneumonia cases.

A key feature of Miqnaf is its coverage of an entire range of community respiratory pathogens, including pneumococci resistant to azithromycin and amoxicillin/clavulanate, making it a promising monotherapy option for community-acquired bacterial pneumonia.

CABP affects millions of people worldwide, with 23% of the global disease burden borne by India, the press release said.

"The current oral antibiotics, such as azithromycin, face significant resistance challenges, while amoxicillin/clavulanate lack the coverage of atypicals; as a result, patients often require hospitalization to take intravenous treatment, which enhances the risk of hospital-acquired infections and imposes higher costs." Miqnaf is designed to obviate the need for such hospitalisation," it said.

Wockhardt is a research-based global pharmaceutical and biotech company. Wockhardt says it is the only company in the world where the USFDA has given QIDP status (Qualified Infectious Disease Product) for six of its antibacterial discovery programs—3 of them are Gram-negative and 3 Gram-positive, effective against untreatable “superbugs”. It has a comprehensive drug discovery team and clinical organisation.

Wockhardt employs nearly 2600 people and 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia, and many other countries. It has manufacturing and research facilities in India, the USA, and the UK, and a manufacturing facility in Ireland.