Wockhardt locks in 5% upper circuit as it nears approval for pneumonia drug

A positive response from CDSCO will give a push to the company efforts to gain the Drugs Controller General of India's (DCGI) final approval for Miqnaf

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Wockhardt shares were locked in a 5 per cent upper circuit on BSE, at Rs 1044.65 per share, in Monday's trade. The rally in the stock came after the pharmaceutical company informed that the Central Drugs Standard Control Organisation (CDSCO), India's regulatory body for cosmetics, pharmaceuticals, and medical devices, has given a favourable recommendation to the company's
antibiotic drug Miqnaf, which is used in the treatment of community-acquired bacterial pneumonia (CABP) among adults.

Community-acquired bacterial pneumonia is found in people who have not recently been in the hospital or any other health care facility such as a nursing home or rehab facility.

At around 12:23 PM, Wockhardt's share price was up 5 per cent at Rs 1,044.65 per share. In comparison, the BSE Sensex was up 0.77 per cent at 81,957.6 at around the same time. The market capitalisation of the pharma company stood at Rs 16,025.24 crore, around the same time.

Through an exchange filing, Wockhardt said, "The Subject Expert Committee (SEC) of Indian drug regulator, CDSCO has provided a favourable recommendation for Wockhardt’s novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults."

The SEC recommendation came after CDSCO’s comprehensive review of the product dossier consisting of non-clinical, US/EU Phase I, Global Phase II, and India Phase III clinical studies conducted over the past 15 years. 

A positive recommendation from India's drug regulatory authority will give a fillip to the company's efforts to gain final approval from the Drugs Controller General of India's (DCGI) for Miqnaf.

Miqnaf is used to treat pneumonia among patients, including those caused by multi-drug resistant (MDR) bugs. The drug has been found to be highly active against azithromycin and amoxicillin/clavulanate-resistant pneumococci, as well as the entire range of pathogens involved in such infections, thus offering a monotherapy option. 

Earlier, a lung penetration study conducted in the US demonstrated best-in-class lung concentrations of Miqnaf, enabling the evolution of a convenient, compliance-friendly treatment for respiratory infections. 

As per the company's filing, community-acquired pneumonia is the most common type of infection, which may lead to hospitalisation and death.

Children and older adults are particularly vulnerable. India contributes to 23 per cent of global community pneumonia burden. 

In the past one year, Wockhardt shares have gained 293 per cent, compared to the BSE Sensex's rise of 23 per cent during the same period.