Pursuant to Regulation 30 of Listing Regulations, please find enclosed Press Release European Medicines Agency Grants Accelerated Assessment to WCK 5222 ".
WOCKPHARMA · price
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Awaiting price reaction for this filing.
Wockhardt's novel antibiotic WCK 5222 (Zidebactam + Cefepime), branded Zaynich®, has been granted Accelerated Assessment eligibility by the European Medicines Agency (EMA) following a pre-submission meeting. The drug targets serious, life-threatening infections caused by multi-drug-resistant and extremely drug-resistant Gram-negative bacteria, including complicated urinary tract infections, hospital-acquired pneumonia, and complicated intra-abdominal infections. This is the first New Chemical Entity discovered and developed in India to be submitted for pan-European marketing authorisation. WCK 5222 has already completed a global Phase III trial, with NDA accepted by the USFDA and Marketing Authorization filed in India. More than 50 patients in India and the U.S. have been treated under compassionate use programs.
Accelerated Assessment shortens EMA's review timeline, bringing a potential EU approval closer and strengthening Wockhardt's case for monetising its lead antibiotic candidate. Positive for long-term revenue given that ~77% of Wockhardt's revenues come from international markets, though actual commercial launch remains subject to full approval.