Wockhardt is gearing up to launch its innovative antibiotic candidate WCK 5222, known as Zaynich, in India by the end of 2024-25, with a global release anticipated in 2025-26. The global market for this antibiotic is projected to be approximately $25 billion.
Wockhardt anticipates no competition for Zaynich worldwide for at least the next 15 years, as no similar drugs are currently in the research pipeline. In India, around 7,50,000 patients suffer from antimicrobial resistance (AMR), compared to 500,000 in the US and 7,00,000 in the EU. Wockhardt’s Chairman, Habil Khorakiwala, informed that the antibiotic will be priced at one-tenth of its global price in India.
Zaynich, a combination of Zidebactam and Cefepime, is effective against infections caused by drug-resistant pathogens, including multi-drug resistant (MDR) and extensively drug-resistant (XDR) superbugs. The global mortality rate for patients infected with MDR superbugs exceeds 30%.
The Clinical and Laboratory Standards Institute (CLSI) has granted Zaynich a susceptibility breakpoint of 64 mg/litre for approximately 10 gram-negative pathogens. For context, recent antibiotics have a susceptibility breakpoint of 4-8 mg/litre, indicating Zaynich’s higher effectiveness against various strains.
The USFDA has designated Zaynich as a Qualified Infectious Disease Product (QIDP) due to its targeting of several critical and high-priority superbugs identified by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and USFDA.
The USFDA has approved an expedited clinical development for WCK 5222, given its potential to meet significant unmet needs in treating difficult infections. In India, the launch will be sooner, with the Drugs Controller General of India (DCGI) requiring a stringent trial involving 60 patients resistant to Meropenem.
As reported by business-standard.com, the first patient recruitment for this trial will begin within a week, and the trial is expected to conclude in six to eight months, targeting a launch by the end of 2024-25. Wockhardt has invested $500 million in research and development over the past 25 years.
