How Wockhardt's bet on multi-drug resistant infections is paying off

Around 2009-10, Mahesh Patel, Wockhardt’s chief scientific officer who was due to retire in a year or so, met chairman Habil Khorakiwala and made an impassioned request. He said he could see “light at the end of the tunnel”, and urged that after his retirement, the pharmaceutical company should not abandon the research project he’d been working on.

 

 The project he was referring to was an ambitious attempt to develop a cure for multi-drug resistant infections — one of the most urgent unmet needs in global health care.

 

 “‘I will work without a salary,’ he said,” Khorakiwala recalls. “Such was his commitment and conviction. I gave him a five-year extension. He’s still with us,” he adds with a smile.

 

 That project has now culminated in Zaynich (WCK 5222), a novel antibiotic combination of zidebactam and cefepime, which is expected to be launched in India in this financial year. Pre-New Drug Application (NDA) meetings with the US FDA concluded in May, with filings expected this quarter and a potential US launch by FY27. The European Union and key emerging markets could see the drug by the second half of FY26.

 

 Zaynich targets drug-resistant Gram-negative infections, particularly carbapenem-resistant strains. (Gram-negative infections are illnesses caused by bacteria that have a unique cell wall structure, which makes them more resistant to certain antibiotics.) In India alone, around 1.1 million patients could benefit from this therapy. In the US and Europe, 371,000 such patients stand to gain. Overall, there are 4.3 million hospitalised cases of these infections annually in the US and EU. 

 

A $9 billion opportunity

 

Wockhardt estimates that across India, the US, Europe, and China, Zaynich can address a potential market of 2 million patients, with a global revenue opportunity of $9 billion (₹78,300 crore). India alone could account for ₹17,000 crore.

 

 For Khorakiwala, 83, Zaynich represents the culmination of a two-decade-long bet on antibiotic innovation. It’s a bet that required sacrifices, resilience, and long-term vision.

 

 In 2009, Wockhardt had defaulted on ₹473 crore in foreign currency convertible bonds. To survive, the company sold assets: 10 hospitals to Fortis for ₹900 crore, the nutrition business to Danone for ₹1,575 crore, and some brands and facilities to Dr Reddy’s Laboratories for ₹1,850 crore. The focus shifted to core products and R&D.

 

 Earlier this month, the company exited its loss-making US generics business, which had posted an 

 

$8 million loss last year. It filed for voluntary liquidation of two subsidiaries — Morton Grove and Wockhardt US — and announced a business realignment.

 

A giant leap in antibiotic R&D

 

“Today, we are the most successful drug discovery company in the world in antibacterial research,” says Khorakiwala, seated in his corner office in Mumbai’s Bandra-Kurla Complex. “Nobody else has more than one new candidate. We have six.” 

 

 The company started with testing 8,000 molecules, spent $500 million on R&D, and emerged with six promising candidates. Large multinationals might have spent $10 billion and not reached where we are, Khorakiwala says.

 

 Wockhardt’s edge, he says, lies in its lean structure. With under 200 people working on R&D, cross-disciplinary collaboration came naturally. “When microbiologists, chemists, and pharmacokinetic teams work together daily, they catch the small things that siloed teams in big pharma often miss.”

 

 Zaynich, Miqnaf (nafithromycin), Odrate (WCK 6777), and Foviscu (WCK 4282) are some of the breakthrough molecules this team has come up with (see chart). 

 

Zaynich has so far saved 51 lives globally through compassionate use — cases where regulatory authorities granted emergency access even before formal approval.

 

 One case involved a critically ill liver transplant patient in the US infected with two pan-drug resistant pathogens: Pseudomonas and Klebsiella. All available antibiotics, including newly introduced ones like cefiderocol and ceftazidime-avibactam, had failed.

 

 A multidisciplinary team from top US institutions — Houston Methodist Hospital, Weill Cornell Medical College, and Johns Hopkins — secured emergency access to Zaynich. After a 14-day course around the time of the liver transplant, the patient showed marked improvement and was transferred out of the ICU within 11 days. Six weeks post-treatment, the infection remained undetectable, enabling the successful resumption of chemotherapy for the underlying cancer.

 

 A case report authored by clinicians highlights Zaynich as a potential treatment option for extensively drug-resistant infections with extremely limited or no treatment options.  

 

 Khorakiwala is a happy man today. “Zaynich is already sold,” he says, referring to the interest from hospitals. “When 50 hospitals use it on critical patients, 500 others hear about it. I get so many personal calls.”

 

 Wockhardt has appointed a merchant banker to explore out-licensing opportunities in Western markets. 

 

“I’m building a front-end business for large markets like the US, but may opt for a partner. I’ll take that call at the right time,” he says. In China, the company plans to follow a partnership-only model.

 

In India, Zaynich will be positioned as a third-line treatment, primarily for ICU patients when other antibiotics have failed. The company’s focus will be on infectious disease specialists in around 200-300 large hospitals — which could cover 70-80 per cent of the target population.

 

“This needs a very different kind of talent than what you need for selling generics,” Khorakiwala says. The Indian commercial team will be fewer than 100 people, and a similarly lean structure will be followed in the US. “Many professionals from multinationals want to join us because most global companies no longer have a pipeline for anti-infectives.”

 

Made in India, for the world

 

Besides putting together a business team, Wockhardt has also secured manufacturing capacities. 

 

The active pharmaceutical ingredient (API) for Zaynich will be manufactured in Ankleshwar, Gujarat. Manufacturing for India and emerging markets will take place entirely in India, where Wockhardt already has end-to-end capacity. With some incremental capital expenditure, this can be scaled up further. 

 

Dependence on Chinese suppliers is not high, says Khorakiwala. “It would be possible to find alternative sources in case of geopolitical tensions.” 

 

For global supply, a third-party FDA-approved facility in Europe will manufacture both the API and formulation for regulated markets.

 

Is Wockhardt considering setting up a plant in the US, given the uncertainties around tariffs?

 

Khorakiwala’s team has already conducted research. “No one manufactures cephalosporins (a key component) in the US, so we’re not at a disadvantage if tariffs are imposed. Everyone, including us, will have to import it,” he says.

 

Cost advantage

 

Wockhardt plans to price the drug 80 per cent lower in India than the rest of the world. Khorakiwala is also clear that he has no intention of exiting the global market even after the drug’s patent expires in 2037. “We’ll continue operating in a market where we would have built an established brand and gained manufacturing experience. That allows us to command a 15–20 per cent premium over the generics that will enter later,” he explains. 

 

While Khorakiwala does not reveal his exact pricing strategy, industry experts point out that treating antimicrobial-resistant infections with next-generation therapies in the US can cost upwards of $10,000 for a week to 10 days of treatment. They expect that Wockhardt may avoid charging a steep premium in the US, choosing instead to match market rates while keeping Indian prices significantly lower to ensure broader access.

 

 In India, doctors are increasingly alarmed by the surge in antimicrobial resistance (AMR) — the ability of bacteria to survive despite treatment with previously effective antibiotics. This trend is driven by factors such as overuse and misuse of antibiotics, over-the-counter sales, poor infection control, and international travel that accelerates the global spread of resistant strains.

 

 Kirti Sabnis, infectious disease specialist at Fortis Hospital Mulund and Kalyan, Mumbai, says India has one of the world’s highest AMR rates, nearing 60 per cent.

 

 “We’re now seeing bacteria like E. coli and Klebsiella pneumoniae that don’t respond to treatment. This poses serious risks, especially to the elderly and immunocompromised patients,” she says. New antibiotics like Zaynich offer hope, with over 97 per cent success in treating carbapenem-resistant infections, she adds. “Importantly, Zaynich also has a safer drug profile than older alternatives like Colistin.”

 

Antibiotic stewardship remains critical, agrees Paritosh Baghel, senior consultant–Internal Medicine at SL Raheja Hospital, Mahim, Mumbai.

 

 “AMR must be tackled at all levels, from doctors to the general public. Antibiotics shouldn’t be used for viral or fungal infections. Only take them when prescribed, always complete the full course, don’t use leftover medication, and never self-medicate,” he advises.

 

In the pipeline

 

Beyond Zaynich, Wockhardt is betting on other antibiotics in its pipeline, such as Miqnaf (Nafithromycin), as well as its biotechnology offerings, including insulin products. 

 

 Miqnaf, already launched in India, is used to treat community-acquired bacterial pneumonia and upper respiratory tract infections. It has received qualified infectious disease product status from the US FDA and has been designated a breakthrough medicinal product in Saudi Arabia.

 

 Miqnaf is targeting a market opportunity worth ₹10,800 crore in India, with more than 96 million potential prescriptions.

 

Outside the antibiotic segment, Wockhardt is optimistic about its biosimilar capabilities, especially in diabetes care. With Danish major Novo Nordisk phasing out human insulin cartridges, Wockhardt sees a ₹450 crore opportunity in India and a $157 million (about ₹1,363 crore) opportunity in emerging markets. The company is doubling its diabetes biosimilar production capacity over the next three years to meet this rising demand, aiming for 20–25 per cent business growth.

 

“In antimicrobials, we follow a leader strategy; in biosimilars, we’re adopting a follower strategy,” says Khorakiwala.

 

Wockhardt has also made steady progress in reducing its debt. As of March 31, 2025, the company’s net debt (excluding promoter debt and net of cash, cash equivalents, and other bank balances) stood at ₹64 crore, a sharp drop from ₹975 crore in March 2023. 

 

The pharmaceutical firm’s journey ahead appears to be on sound footing. 

What’s working for Zaynich (WCK 5222)

• A new class of antibiotics after >30 years to treat Gram-negative infections
• Global Phase-III clinical study: Achieved 20% higher (statistically superior) composite cure over gold standard meropenem
• Saved 51 lives so far in compassionate usage, including three in the US
• Only product granted with an investigational breakpoint of 64 mg/l for all major Gram-negative pathogens by the Clinical and Laboratory Standards Institute, US