In a significant advancement for antibiotic research, Mumbai-based Wockhardt is preparing to introduce its novel antibiotic candidate, WCK 5222 (Zaynich), in India by the end of 2024-25, with a global release slated for 2025-26. The global market for this antibiotic is projected to be approximately $25 billion.
Wockhardt anticipates no competition for this drug worldwide for at least the next 15 years, as there are no other similar drugs in research pipelines. In India, approximately 750,000 patients suffer from antimicrobial resistance (AMR), while in the US, this number is around 500,000, and in the EU, it is about 700,000.
Zaynich has been granted a susceptibility breakpoint of 64 mg per litre for around 10 gram negative pathogens showing high resistance rates by the American Clinical and Laboratory Standards Institute, according to a statement.
He stated that the company expects to receive final approvals from Indian regulators to launch the antibiotic by the end of FY25 and plans to begin commercial distribution shortly thereafter. For developed markets, the company anticipates approvals within a similar timeframe, possibly with some delay, Khorakiwala added, outlining the commercial strategies.
In India, the company intends to sell the antibiotic at one-tenth of the price set for developed markets, focusing primarily on pneumonia patients. In developed markets, it will seek partners to help establish distribution networks for the antibiotic. Khorakiwala highlighted that with local antibiotic resistance levels at 60 percent and global levels at 35 percent, this represents a significant market opportunity.