Wockhardt Limited submitted a regulatory disclosure pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, announcing that the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for its indigenously developed antibiotic ZAYNICH® (Zidebactam/Cefepime).

The approval covers import and marketing in India for treatment of adult patients (≥18 years) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram-negative bacteremia.

The approval is supported by results from the pivotal ENHANCE-1 study (NCT04979806), a multinational, randomized, double-blind Phase 3 clinical trial comparing ZAYNICH® with meropenem in patients with cUTI including pyelonephritis. Patients were randomized in a 2:1 ratio to receive ZAYNICH® or meropenem.

Key Clinical Trial Results:

  • Primary composite endpoint of clinical cure and microbiological eradication at test-of-cure (TOC) visit: 89% (250/281) for ZAYNICH® versus 68.4% (93/136) for meropenem
  • Treatment difference of 20.6% in favor of ZAYNICH®
  • TOC assessment conducted approximately 10 days after completion of therapy
  • Among patients with concomitant bacteremia at baseline: 89% (16/18) response rate for ZAYNICH® versus 44% (4/9) for meropenem

Development Background:

ZAYNICH® was evaluated across nine Phase 1 studies and a Phase 2 clinical study involving patients with documented meropenem-resistant Gram-negative infections. The Phase 2 study was conducted across 15 leading tertiary care hospitals in India and demonstrated over 97% clinical efficacy across serious infections including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.

Compassionate Use Data:

Under compassionate use, ZAYNICH® demonstrated strong clinical efficacy in 85 cases of Extensively Drug Resistant (XDR) Gram-negative infections across India, the United States, Malaysia, and France where no safe and effective alternatives were available.

Global Regulatory Status:

  • New Drug Application (NDA) submitted in the United States - currently under regulatory review
  • Marketing Authorisation Application (MAA) submitted in the European Union - currently under regulatory review
  • Received Priority Review, Fast Track and Qualified Infectious Disease Product (QIDP) designations by US FDA for Complicated Urinary Tract Infections (cUTI), Complicated Intra-Abdominal Infections (cIAI), Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP)

Product Mechanism:

ZAYNICH® is an injectable antibiotic comprising β-lactam enhancer antibiotic Zidebactam and cephalosporin antibacterial drug Cefepime. Zidebactam selectively inhibits penicillin-binding protein-2 (PBP2) while Cefepime primarily targets penicillin-binding protein-3 (PBP3) in Gram-negative bacterial pathogens.

The Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential to cover clinically important extensively drug-resistant (XDR) Gram-negative pathogens.

Company Context:

Wockhardt is a research-based global pharmaceutical and biotechnology company focused on developing innovative anti-infective solutions. The company has a pipeline of six antibiotics at various stages of clinical development and commercialization, with three targeting Gram-Negative pathogens and three targeting Gram-Positives. All six antibiotics have been granted Qualified Infectious Disease Product (QIDP) designation by the US FDA.

Wockhardt employs approximately 3200 people across 27 nationalities with presence in India, the UK, the U.S., Ireland, Switzerland, France, Mexico, Russia, and other countries. The company has manufacturing and research facilities in India & the UK, and a manufacturing facility in Ireland. 78% of its global revenues come from international businesses.