Wockhardt Gets Approval For Two New Antibiotics Targeting Superbugs
Brightly coloured pharmaceutical medication, including antibiotics, paracetamol, Ibuprofen and cold relief tablets in the U.K. (Photographer: Chris Ratcliffe/Bloomberg)

Wockhardt Gets Approval For Two New Antibiotics Targeting Superbugs

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WATCH | Habil Khorakiwala speaks to BloombergQuint on new drugs approval.

Drugmaker Wockhardt Ltd. on Thursday said that it has received approval from the Drug Controller General of India for its two new antibiotics indicated for the treatment of acute bacterial skin and skin structure infections.

The approval by the DGCI is for novel antibiotics discovered and manufactured in India by an Indian company, Wockhardt Managing Director Murtaza Khorakiwala said in a media conference call today.

"DCGI has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK 0 (Oral), for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia...," the drug firm said in a regulatory filing.

The approval for the two novel antibiotics by the DCGI paves way for a Rs 100 crore opportunity for the company in the country over 18 to 24 months on an annual basis, he added.

The size of Indian antibiotic market is around Rs 16,000 crore, growing at 7 percent and is one of the largest therapeutic segment, with around 12 percent market share of the Indian pharmaceutical market, Khorakiwala said.

The new drug will target a superbug like Methicillin-resistant Staphylococcus aureus, which is a leading cause of rising antimicrobial resistance.

"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," Habil Khorakiwala, founder chairman of Wockhardt, said in a statement.

Antimicrobial resistance is a major public health problem globally. India carries one of the largest burdens of drug-resistant pathogens worldwide, the statement said.

Also read: Wockhardt Gets U.S. FDA Nod For Generic Cancer Drug

AMR is a major public health problem globally. India carries one of the largest burdens of drug-resistant pathogens worldwide. 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, healthcare systems, and hinder the goals of sustainable development.

Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development, it added.

Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts, muscle pain, to name a few, which limits their use for a longer period and compromise the safety of critically ill patients in the ICU, the statement said.

Two million deaths are projected to occur in India due to AMR by the year 2050, Wockhardt said. The anti-MRSA agents currently available have multiple side-effects—such as kidney damage, decrease in platelet counts and muscle pain, which limits their use for a longer period and compromise the safety of critically ill patients in the ICU.

Shares of Wockhardt Ltd. were trading at Rs 276.45 per scrip on BSE, up 6.72 percent from its previous close.

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