Excerpt from Chairman’s Speech at AGM, convened on June 28, 2024, at 11 am
- Over a span of 25 years, we dedicated substantial efforts to establish a global antibiotic research organisation.
- Fostered a culture of Research and Innovation, collaborating with more than 30 global organisations.
- Invested over US$ 500 million in discovering antibiotics to address unmet medical needs.
- Our diverse antibiotic portfolio tackles antimicrobial resistance across various classes, developed over 30-40 years, targeting infections in both hospital and community settings.
EMROK & EMROK O
- EMROK & EMROK O have treated more than 65,000 patients.
- Successfully concluded 4 new clinical studies covering bloodstream infections, bone and joint infections, community-acquired bacterial pneumonia, and infections in immunosuppressed patients.
- Completed New Drug Application (NDA) submissions in 10 Emerging Markets countries and aiming for 5-6 additional countries by Q2 of FY 2025.
- Anticipating substantial growth in the current year due to these expansions.
WCK 4873 (Nafithromycin), trademarked as MIQNAF
- MIQNAF (WCK 4873) offers an ultrashort, 3-day oral treatment for community-acquired bacterial pneumonia, achieving a 97% success rate.
- Current treatments face up to 60% resistance.
- Filed New Drug Application (NDA) with the Drug Controller General of India (DGCI) and anticipate commercial launch in India by the second half of FY25.
- Planning NDA filings in selected Emerging Markets and foreseeing strong sales in FY26.
WCK 5222 (Zidebactam/Cefepime), trademarked as ZAYNICH
- A groundbreaking new antibiotic developed by Wockhardt.
- This proprietary drug, designed to combat major superbugs, is the first of its kind discovered in the past 50 years.
- Currently in Global Phase 3 clinical trials.
- ZAYNICH was granted compassionate use approval by the DCGI for 30 critically ill patients unresponsive to existing antibiotics.
- Achieving a 100% success rate, ZAYNICH saved the lives of all recipients, with notable cases published in prestigious international journals.
- To date, ZAYNICH has saved over 30 lives, with DCGI approval secured for a small-scale clinical trial involving carbapenem-resistant patients in India.
- Pending completion by FY25, approval would enable ZAYNICH to become available in India, marking a significant milestone in its clinical deployment.
- The US FDA granted ‘Expanded Access IND’ approval for WCK 5222 (ZAYNICH) to treat a young cancer patient at the University of California Irvine School of Medicine, Orange County.
- Despite nine months of unresponsiveness to current US antibiotics, the patient showed significant improvement within four weeks of ZAYNICH administration.
- The treatment resulted in complete healing of large wounds and eradication of infections, allowing the patient to resume chemotherapy for ongoing cancer treatment.
- CLSI, a globally-recognized US body, has approved a susceptibility breakpoint of 64 mg/L for ZAYNICH.
- This breakpoint applies to a wide spectrum of Gram-negative pathogens resistant to multiple drugs.
- ZAYNICH demonstrates unprecedented effectiveness with its high bacteria kill power, crucial for extreme multi-drug resistant organisms.
- For the first time, a breakpoint of 64 mg/L covers the entire spectrum of 10-resistant Gram-negative pathogens, underscoring ZAYNICH’s clinical potency.
- Clinical trials under compassionate use show a 100% success rate in critically ill patients, affirming its safety and efficacy over 70 days.
- ZAYNICH’s achievement of the investigational breakpoint at a CLSI plenary session on June 24, 2024, marks a historic milestone, a source of pride for Wockhardt and India.
- Global Phase III clinical trials for ZAYNICH are anticipated to conclude by FY25.
- Plans include filing for regulatory approvals in the US, Europe, and other regions following trial completion.
- Global approval for ZAYNICH’s launch worldwide is expected in FY26.
- Strategically, we aim to maximize market value through a dual strategy: direct marketing in India and Emerging Markets, alongside licensing agreements with global pharmaceutical companies for US, Europe, and other developed regions.
Source: https://www.wockhardt.com/wp-content/uploads/2024/06/chairmans-agm-speech-2024.pdf
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