Forbes India
India built one of the world's great pharmaceutical industries on the back of generics—affordable, high-quality medicines that reach billions globally. But originating a molecule entirely from scratch? That's a different endeavour.On May 30, the US Food and Drug Administration (FDA) approved Zaynich—a novel intravenous antibiotic developed entirely by Mumbai-based Wockhardt—making it the first New Chemical Entity (NCE) fully invented, developed, and commercialised by an Indian pharmaceutical company to receive FDA approval. An NCE, in plain terms, is a molecule that did not exist before."This approval represents a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry," says Dr Habil F Khorakiwala, founder and chairman of Wockhardt Group, in a press release.Also Read: "Generics Play an Important Role”: Eli Lilly on GLP-1 CompetitionSo, what does it actually take?Drug discovery is completely different from generics. It begins not with a known molecule but with a biological problem—in this case, bacteria that have evolved to resist virtually every antibiotic in use. Wockhardt's scientists, starting in 2011, had to identify a new mechanism of attack, synthesise a novel molecule (zidebactam), combine it with an existing antibiotic (cefepime), and run it through a decade of clinical trials.What makes Zaynich clinically distinctive is its mechanism. Unlike most antibiotics in its class, which target a single bacterial protein, Zaynich attacks three simultaneously, making it significantly harder for bacteria to develop resistance. The result is an antibiotic that can kill drug-resistant bacteria for which doctors currently have almost no treatment options.The Phase 3 results were striking. In its pivotal Phase 3 trial—a randomised, double-blind study conducted across 64 sites in the US, Europe, Latin America, China, and India, known as the ENHANCE-1 study—Zaynich achieved an 89 percent composite cure rate against complicated urinary tract infections (cUTIs), compared with 68.4 percent for meropenem, currently the last-resort antibiotic for such cases."The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of Zaynich is a monumental step forward in validating a new option for these underserved populations," states Dennis Deruelle, chief medical officer at Wockhardt, in the release.Complicated urinary tract infections alone account for over 600,000 hospitalisations in the US annually—a growing share caused by multidrug-resistant bacteria.Why it Matters Beyond Wockhardt?Zaynich is only India's second FDA-approved NCE. The first was enmetazobactam, invented by Chennai-based Orchid Pharma—but out-licensed to a German biotech for development and commercialisation. Wockhardt retained full ownership of Zaynich."It's a proud moment for the Indian pharma industry," says Vishal Manchanda, equity research analyst - Pharma, Systemix Group. "Zaynich is expected to save many lives."The approval also comes amid an escalating global antimicrobial resistance crisis. Over 2.8 million resistant infections occur in the US alone each year, killing more than 35,000 people. "There is an ongoing need for new antibiotics to combat these drug-resistant pathogens," says Keith Kaye, professor of Medicine at Rutgers Robert Wood Johnson Medical School, who was involved in the ENHANCE-1 study.The Drugs Controller General of India (DCGI) approved Zaynich in India on May 27, three days before the FDA. A marketing application is pending with the European Medicines Agency (EMA).
Go to News Site
