Cefepime/Zidebactam

Mumbai: Wockhardt is working on ambitious plans for Zaynich , a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of ’26. In the US, it plans to file for regulatory clearance in August.“We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,” Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for. “We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,” Khorakiwala said. “One option is licensing out, the other is in some markets like in India we are doing ourselves,” he said. “The US is another market where we are thinking of the possibility (of marketing on its own); you don’t need too much marketing cost and you have talent available.” Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part. “For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,” said Khorakiwala. “Zaynich — we are manufacturing everything in Europe.” It will adopt the same strategy to outsource most of the manufacturing for all its other new products. The company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. “That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,” he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. “We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,” said Khorakiwala. He also stressed on the company’s focus on biologics as another key growth driver. “Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,” he said. Wockhardt does not see itself as a generic company, he said. “In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,” he said. The chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said. By Rica Bhattacharyya ,

New York: Drugmaker Wockhardt on Friday said its novel antibiotic Zaynich has an addressable market opportunity of USD 7 billion in the US and Europe. The company said it has completed a pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA) in May 2025. Filing to the USFDA is slated in the second quarter of the current fiscal with potential launch in FY2026-27, Wockhardt Ltd said in a regulatory filing. The company plans for regulatory approval for the product in Europe and emerging markets in the second half of the current financial year, it added. Wockhardt said it has also filed for approval of Zaynich with the Drug Controller General of India (DCGI) and expects to launch the product in the domestic market in the second half of the current fiscal. The antibiotic, to be used against gram-negative infections, is expected to help 11 lakh cases in India alone, the Mumbai-based drug maker said. In May, the drug firm reported a narrowing of consolidated net loss at Rs 45 crore in the fourth quarter ended March 31, 2025. The company had reported a net loss of Rs 177 crore in the January-March quarter of FY24. Revenue from operations rose to Rs 743 crore in the fourth quarter as compared to Rs 700 crore in the year-ago period. For FY25, the company said its net loss stood at Rs 57 crore against Rs 472 crore in the year-ago period. Revenue increased to Rs 3,012 crore from Rs 2,798 crore in the 2023-24 fiscal. Shares of Wockhardt Ltd on Thursday ended 2.42 per cent higher at Rs 1,528.60 apiece on the BSE.