Wockhardt gets nod for drugs to treat superbugs

Indian antibiotic market is ₹16,000 cr.

The Drug Controller General of India (DCGI) has approved Wockhardt’s two new antibiotics, EMROK (IV) and EMROK O (oral), for acute bacterial skin and skin structure infections, including diabetic foot infections and concurrent bacteraemia.

The approval is based on phase three study involving 500 patients in 40 centres across India.

The drugs will target super bugs such as Methicillin-resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR) among patients The size of Indian antibiotic market is estimated at ₹16,000 crore, growing at 7%.

Workhardt, which will launch these drugs in India shortly, plans to capture a large part of the antibotic-resistance market which is a smaller but growing segment of the antibiotic market.

“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,” said Habil Khorakiwala, founder-chairman and group CEO, Wockhardt Ltd., said in a statement.

Murtaza Khorakiwala, MD, Wockhardt Ltd. said that India carries one of the largest burdens of drug-resistant pathogens worldwide, which the new drugs target.

“Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalisation, causing a huge financial burden to the affected persons and hinder the goals of sustainable development,” he said

“Two million deaths are projected to occur in India due to AMR by the year 2050 and the newly-discovered drug will address this concern,” he added

“EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across the globe,” he added.

Clinical and non-clinical studies have established advantageous safety features of the drugs compared with older MRSA drugs, the company said.

At a time when many major pharmaceutical firms have steered away from the antibiotic research in the last 30 years, Wockhardt Ltd. has invested for more than two decades in developing a strong antibiotic pipeline. It is the only company in the world having five antibiotics against super bugs in the late phase of clinical development out of which two have been approved, according to Dr. Murtaza Khorakiwala.

Source: Read Full Article