Wockhardt's Zaynich has become the second homegrown new drug from India to receive US FDA approval, marking a historic achievement for the Mumbai-based pharmaceutical company. The stock surged over 16% intraday on Monday before closing up 5.25% at ₹2,138 on the NSE, with the company's share price having increased by 46.86% in the past year - significantly outperforming the benchmark Nifty Pharma's 13.18% rise. This approval validates chairman and founder Habil Khorakiwala's bet on antibiotic discovery and development, even as Big Pharma companies in developed economies stopped such research in favor of more lucrative drugs. The company secured regulatory approval for Zaynich in India last week and plans to launch domestically in about five months, with European and UK approvals expected this year and launches a year later.
Wockhardt founder and chairman Habil Khorakiwala announced the company will commercialise its novel antibiotic Zaynich on its own in the US instead of licensing it to a global pharmaceutical company. According to reports from Moneycontrol, Khorakiwala explained that the company had both options available but chose self-commercialisation to retain more value from the product and build a platform for future launches. "We had both the options available. We thought this is a better option because tomorrow I introduce another drug, I don't need — my organisation is already there," Khorakiwala stated. The company is targeting a US launch within six to eight months, with the India rollout expected slightly earlier. Unlike generics or copycat drugs, selling branded NCEs requires physician education, direct advertising, and rebate negotiations, but Wockhardt's focus on severe ICU cases will involve lower physician education costs through hospital outreach.
Zaynich has received approvals in India and the US, with the latest FDA clearance marking a significant regulatory milestone. The company estimates the drug's global peak sales potential at $1.5-2 billion annually, with the benchmark being newer antibiotics already on the market that collectively generate about $1 billion in annual sales. In India, the company estimates that approximately 1.1 million resistant infection cases could potentially be treated with Zaynich, translating into a market opportunity of about ₹17,000 crore. Across the US and European markets, the company estimates the addressable opportunity at around $7 billion. Khorakiwala expects revenues from Zaynich to begin in FY28, with a sharper scale-up in FY29, describing the timeline as "FY28 onwards revenue will start, FY29 would be zoom year. It will be like hockey stick." The US price point for these new antibiotics is $10,000-$15,000 per treatment for a seven to 10-day course, with India representing 75-80% lower pricing considering affordability.
Zaynich, a next-generation antibiotic designed to treat drug-resistant infections, has now received approvals in India and the US. The drug has been approved for treating complicated urinary tract infections caused by Gram-negative bacteria, including strains that have developed resistance to existing therapies. In its Phase III trials, the drug demonstrated better efficacy compared to meropenem - another antibiotic used to treat severe bacterial infections - with a response rate of 89% versus 68.4%. The drug uses an "enhancer" mechanism rather than a beta-lactam inhibitor, making it different from traditional antibiotics used against resistant bacteria. Khorakiwala noted that Zaynich will have to be marketed through scientific and medical engagement rather than conventional commercial promotion, stating "New drug goes only on scientific and medical — there is no commercial element." The drug is a combination of cefepime, an existing antibiotic, and zidebactam, a new molecule designed to enhance its effectiveness, with cefepime working by killing bacteria while zidebactam helps protect it from being neutralised by bacterial defence mechanisms.
Wockhardt has started building the commercial structure needed for the US launch, as reported by Moneycontrol. The company has put in place a leadership team across medical, sales, marketing and market access, while operational functions such as data management are being outsourced. Khorakiwala explained the strategy: "The leadership is in-house, the operational people can be outsourced." The company is setting up a similar model for Europe as well. Wockhardt is setting up a leadership team to handle the key profiles in medical, sales and marketing, market access, etc., in the US, with operational tasks like sales force being outsourced to a third party firm. The company has patents for all six novel drugs in its pipeline, with Zaynich's patent continuing for 10-11 years. Wockhardt doesn't see liquidity as an issue and has no immediate plans to raise funds, with the company's focus on advancing its R&D and product pipeline. The company is also developing WCK 6777, a beta-lactam enhancer that pairs zidebactam with ertapenem instead of cefepime, designed as a once-daily pill for infections caused by carbapenem-resistant Gram-negative pathogens, offering convenience for outpatient treatment.
