Wockhardt plans to file a new drug application (NDA) for Zaynich, a breakthrough antibiotic against drug-resistant infections, with the US drug regulator in the second quarter of this fiscal, the company said on June 5, targeting a potential launch in FY27.
Zaynich, a new antibiotic targeting the most severe of multi-drug resistant infections, has completed its global Phase III clinical study with results showing a 20 percent higher cure rate over Meropenem, the benchmark drug.
"Coming to the United States, there is a very high certainty, I would say, that we should be able to market the product sometime in 2026-27," Wockhardt chairman Habil Khorakiwala told Moneycontrol on the sidelines of an event celebrating the company's 25 years of being listed on the National Stock Exchange of India (NSE).
The pharma firm had a pre-NDA meeting with the US Food and Drug Administration (FDA) in May for necessary feedback before going ahead with the proposed filing, the management said.
The Mumbai-based drugmaker has already sought the approval of the Drug Controller General of India (DCGI) to launch Zaynich in India and plans to do the same for Europe and emerging markets in the second half of FY26.
"We expect Zaynich approval [in India] sometime coming in the beginning of next year, and we should be in the Indian market in the middle of next year," Khorakiwala said.
A game changer?
Khorakiwala, 83, has been on a relentless pursuit of novel antibiotics for 25 years, even as the company battled many ups and downs along the way. Wockhardt spends about Rs 200 crore on R&D annually. Its145-member strong R&D team has 50 PhDs.
If Zaynich gets an FDA nod, the market potential is substantial.
Wockhardt estimates an addressable pool of approximately 2 million patients globally in select markets.
In India alone, the company sees a market of around 1.1 million cases, translating to a potential business of Rs 17,000 crore annually. For the US and European markets, Zaynich offers a $7 billion opportunity, targeting roughly 371,000 carbapenem-resistant cases. China has another 657,000 patients.
Carbapenems are a class of antibiotic agents mostly used in treating severe bacterial infections.
Khorakiwala said Wockhardt will market Zaynich in India on its own. In the US, the company, while open to possibilities of a licensing deal, is also putting in place commercial teams and leadership to market the drug on its own.
"If we get a good valuation, we may consider that (out-licensing) as an option but if we don't see that kind of valuation coming, we will do it ourselves," Khorakiwala said.
Large global companies have shown interest in partnering Wockhardt to commercialise Zaynich, he said. In Europe and other markets, Wockhardt will likely look at partnerships.
On May 27, Wockhardt launched Miqnaf (Nafithromycin) in India, introducing a new macrolide antibiotic class after more than 30 years, targeting community-acquired bacterial pneumonia (CABP) and other respiratory tract infections (RTI).
Miqnaf demonstrated a 96.77 percent cure rate in Phase III trials for CABP. The company is targeting 96 million prescriptions in India, representing an addressable market opportunity of around Rs 10,800 crore annually.
"After 15 years, there is a new antibiotic class which is there in the Indian market with Miqnaf," Wockhardt managing director Murtaza Khorakiwala said at an investor presentation on June 5.
Wockhardt’s antibiotic pipeline includes Foviscu (WCK 4282), for which Phase III trials are on, targeting empiric use for severe bacterial infections. Odrate (WCK 6777), an outpatient therapy for severe multidrug-resistant (MDR) infections, has completed Phase I clinical studies in collaboration with the NIH in the USA.
Wockhardt is also strategically positioned to capitalise on the shifts in the diabetes-care market. With Novo Nordisk planning to discontinue certain insulin pens and cartridges, Wockhardt sees a significant opening. This development presents an opportunity estimated at Rs 450 crore in India and $157 million in emerging markets.
"That space opens up for existing players in the insulin market... We are well positioned in this space to capitalize on this opportunity," an executive said. To meet this anticipated demand, Wockhardt plans to "double our capacities over the next 24 months", Murtaza Khorakiwala said.
The company has filed for approval to market Insulin Aspart in India and has a pipeline including Aspart Mix and Lispro R, alongside its commercialised Recombinant Human Insulin and Glargine.
Wockhardt reported a 67 percent year-on-year growth in EBITDA at Rs 418 crore for FY25, with a significantly improved net debt-to-equity ratio of 0.01, signalling a healthier balance sheet.
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