Looking beyond generics: Wockhardt is showing the way in antibiotics

Wockhardt's FDA-approved Zaynich marks a breakthrough in India's pharmaceutical innovation, offering a new weapon against antimicrobial resistance

The recent approval given by the United States’ Food & Drug Administration (FDA) to Zaynich, an antibiotic that Wockhardt has developed, is a landmark event for India and the global pharmaceutical industry. Zaynich may be prescribed to treat complicated urinary-tract infections (UTIs) and other related diseases. It enters a global antibiotic market valued at roughly $9 billion, and has patent protection until 2038. In America, Wockhardt may price Zaynich at $10,000-12,000 for 7-10 day courses, at rates comparable to other treatments in that country. Pricing in India will be much lower. Estimates suggest that peak sales for Zaynich could hit $1.5 billion by FY29.

 

Urinary-tract infections may be caused by multidrug-resistant bacteria. Antimicrobial resistance (AMR), as it is known, makes such infections hard to treat. Treating AMR infections may involve “last resort” antibiotics like Colistin, which are themselves toxic. Complicated infections in America are responsible for over 600,000 cases of hospitalisation annually, while India suffers 250,000. Zaynich is an injectable combining two key components: Cefepime and Zidebactam. Cefepime is a cephalosporin antibiotic, and Zidebactam is a new molecule. The two active ingredients attack different proteins, making Zaynich effective against multidrug-resistant, gram-negative bacteria. Zidebactam is a “new chemical entity (NCE)”, defined as a molecule that did not exist before being created in the lab.  It is only India’s second FDA-approved NCE. The first, Enmetazobactam, was invented by Orchid Pharma and licensed to a German biotech for commercialisation.

 

India has a significant presence in global generic drugs. However, it is not known for cutting-edge pharmaceutical research and development (R&D). Wockhardt took a big gamble by focusing on antibiotics and is following up with an ambitious strategy of doing its own global marketing. Over the years, the company has invested around $800 million in R&D, developing six antibiotic molecules so far. If the other molecules win regulatory approval, it would become a global leader in the space. New antibiotics would fill a critical gap. Global pharmaceutical giants have pulled back from researching antibiotics. In 2023, only 15 innovative antibiotic molecules were seeking regulatory approval. Since then, four have been approved, one is under review, and 10 have been discontinued. All drug R&D is expensive and risky, but antibiotic R&D is riskier than most.

 

The journey can take decades and cost billions. Rates of failure are high, with the odds of success being literally one in a million. Patents are granted for about 20 years. Once a drug is off-patent, cheaper generics are easily developed. Since bacteria mutate quickly to develop resistance, a new antibiotic may soon cease to be effective. Hence the net present value of a new antibiotic is low. The reluctance to enter R&D in antibiotics has led to a growing public health emergency. Drug resistance is estimated to directly cause 1.3 million deaths annually, and contribute to five million more deaths. In 2021, India suffered 266,000 deaths directly attributed to AMR, with another 987,000 deaths where AMR was a contributory factor. Indian companies like Wockhardt are seeing opportunities in this space, given the exit of global giants.  An increasing focus on such high-risk research could propel India’s drug industry into a new phase of growth and innovation.