Mumbai-based pharma company Wockhardt Ltd has achieved something no other pharma company has managed to do, until now. The company has filed an application to the US Food and Drug Administration (USFDA) for its new breakthrough drug, Zaynich. Many in the medical fraternity are hailing it as a once-in-a-generation breakthrough, an antibiotic that could address a challenge doctors are increasingly facing worldwide- antibiotic resistance.
A silent, stubborn challenge facing humanity
Despite the rapid advances made in medical technologies, antibiotic resistance (AMR) remains a challenge that has been brewing for years, with more than 3 lakh deaths attributed to it. Widely available antibiotics are sometimes ineffective for some ailments, mainly because the virus responsible for the disease has mutated itself to protect itself from death.
This has become a far greater public healthcare challenge than ever, with AMR deaths surpassing that of HIV, malaria and breast cancer. Common viruses responsible for diseases, such as E. coli, Klebsiella, and Pseudomonas, have developed resistance rates of 50-90% over the years.
Zaynich- a ray of hope
At this juncture, Zaynich comes with a ray of hope, with Phase 3 trials showing this drug has a 20% better cure rate than Meropenem, a commonly used drug used to treat high AMR. Most antibiotics quickly lose effectiveness against resistant strains of viruses, Zaynich addresses this by combining the best of two powerful components- Cefepime and Zidebactam. Laboratory studies show how Zaynich remains 97% effective against drug-resistant bacteria, including Pseudomonas aeruginosa, a commonly found bacterium that has increasingly become a health threat due to its resistance to widely available antibiotics.
Why this is a breakthrough like no other
Drug-resistant infections have become a worldwide health crisis like no other, with an estimated 1.27 million people losing their lives due to this ‘silent pandemic’. The World Health Organization (WHO) has listed AMR as one of the top global health threats, with doctors forced to use highly potent, last-resort antibiotics to address the challenge.
According to reports, doctors who have used Zaynich in emergency situations have witnessed positive results, both here in India and in the US. Wockhardt has submitted the NDA after extensive drug trials, while the FDA is expected to approve the drug within 10 months, if all goes well. Meanwhile, the company has also filed an application with the Drug Controller General of India, (DGCI), with the launch expected in the second half of this financial year (FY25-26).
From manufacturer to innovator
Indian pharmaceutical companies have long been known as the pharmacy of the world, but mostly to produce low-cost copies of drugs developed in the West. With this development, this would show India’s arrival in the R&D space for drug discovery, where we’ve lagged for years.
This little-known pharma company could become a multibagger stock overnight, following its press release to the bourses on October 01. The stock was trading at Rs.1,484 at 11.30 AM on October 01, and is set to rise significantly in the future.
Disclaimer: This article is for informational purposes only and does not constitute financial advice. Readers should conduct their own research or consult with a qualified financial advisor before making any investment decisions.
