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biotech/news//Moneycontrol
Shares of pharma major Wockhardt surged more than 10% on Monday.
Wockhardt received US FDA approval for its novel antibiotic Zaynich targeting drug-resistant Gram-negative bacteria.
KEY POINTS
Zaynich addresses complicated urinary tract infections, including pyelonephritis, and combats antimicrobial resistance.
The drug's global addressable market is estimated at $9 billion, with $7 billion in the US and Europe.
Wockhardt is among a limited number of Indian firms to achieve US and India regulatory clearance for proprietary antibiotics.
Large pharmaceutical companies have retreated from antibiotic research, leaving a market gap Wockhardt is targeting.
Shares of pharma major Wockhardt surged more than 10% on Monday after the company secured US Food and Drug Administration (FDA) approval for its novel antibiotic Zaynich, a major milestone in its decades-long research effort.
The stock had surged as much as 16.21% at the opening trade following the FDA approval announcement before paring some gains. It was still up 12.2% at Rs 2,279 on the NSE at 9:42 am on Monday.
Zaynich is designed to treat complicated urinary tract infections (cUTI), including pyelonephritis, and targets infections caused by drug-resistant Gram-negative bacteria.
The approval comes at a time when antimicrobial resistance is emerging as a growing global health challenge, limiting treatment options for physicians.
For Wockhardt, the approval marks the culmination of years of investment in building a proprietary antibiotic research pipeline.
With regulatory clearances now secured in both the US and India, the company has crossed a significant scientific hurdle that only a handful of Indian pharmaceutical firms have achieved.
The focus now shifts to commercial execution. Having demonstrated its ability to discover and develop a globally relevant antibiotic, Wockhardt must prove that innovation can translate into sustainable revenue growth and profitability.
"Here what you are seeing is our success in research, I want you to see success as a business," founder-chairman Dr Habil Khorakiwala had told Moneycontrol earlier this year, highlighting the company's ambition to convert scientific breakthroughs into commercial success.
Wockhardt's antibiotic programme addresses a critical gap in the market left by large global pharmaceutical companies that have scaled back investments in antibiotic research. The company is focused on combating Gram-negative resistant infections, one of the most difficult and rapidly evolving threats in infectious diseases.
According to company estimates, around two million patients globally suffer from Gram-negative resistant infections. Wockhardt pegs the total addressable market for Zaynich at nearly $9 billion across the US, Europe and India.
In India alone, the company estimates that nearly 1.1 million resistant infection cases could be addressed by the drug, translating into a market opportunity of around Rs 17,000 crore. Across the US and Europe, Wockhardt estimates the addressable opportunity at roughly $7 billion.