'USFDA nod for Zaynich a major boost'

NEW DELIH: The US Food and Drug Administration’s (USFDA) approval of Wockhardt’s Zaynich, a first-in-class ``breakthrough antibiotic'' for severe drug-resistant infections, opens up a significant global market opportunity and marks a watershed moment for India’s pharmaceutical industry, the company’s founder chairman Habil Khorakiwala told TOI on Monday. Zaynich, a combination of cefepime and zidebactam, is the first novel drug discovered and developed in India to secure USFDA approval, with peak sales estimated at over $1.5 billion, he said. The achievement demonstrates the country's capability to develop innovative medicines and would inspire research here, he added. The development adds to the momentum generated by Glenmark's $700 million out-licensing deal of its cancer molecule to AbbVie last year, underscoring the industry's increasing focus on pursuing high-risk, innovation-led research. Historically, India, known as the world's generics powerhouse, has been a global leader in affordable drug manufacturing, while investments in innovation have been limited. With patent protection through 2038, Khorakiwala is betting on Zaynich, which targets multidrug-resistant "superbugs" and complicated urinary tract infections. Wockhardt plans to price Zaynich in line with prevailing US treatment costs of $10,000-$12,000 for such infections, while pricing in India is likely to be significantly lower. Wockhardt shares jumped about 19% to a 52-week high of Rs 2,420 before ending the day nearly 6% higher at Rs 2,152. “The global antibiotics market is estimated at roughly $9 billion, while for such life-saving treatments we expect the global opportunity to be around $1.5 bn.The upside will depend on how quickly the company ramps up its commercial presence”, Vishal Manchanda analyst at Systematix said. Wockhardt plans to launch the novel antibiotic by year-end or early 2027 in the US and India, followed by Europe a year later. It recently obtained regulatory approval in India. The company will establish a leadership team in the US and set up sales and market access, while manufacturing will be outsourced to a European facility in Italy. Over the past two decades, Wockhardt has invested around $800 million in R&D, developing six antibiotic molecules through a frugal, India-based research model that the company says has enabled innovation at a fraction of global drug-development costs. With a few of its other candidates also on track for a fast-track US regulatory approval, the company is strengthening its position as a global innovator in antibiotics. The company has sufficient liquidity to support the operations and growth plans for the next two years, he said. The USFDA grants approval on a priority basis to life-saving drugs and those which fulfill an unmet need. Under this process, Zaynich received the green light within six months. Complicated UTI is responsible for over 6 lakh hospitalizations in the US annually, while in India there are 2.5 lakh cases annually.