A leading European Journal reports Renal Transplant Patient’s unique Clinical Case of Successful use of Zidebactam/Cefepime (WCK 5222, Zaynich TM ) to Treat Skull Bone Infection & Pneumonia caused by Extreme – drug Resistant Pseudomonas

Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Aurangabad - 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com Mumbai, 11th March 2024 A leading European Journal reports Renal Transplant Patient’s unique Clinical Case of Successful use of Zidebactam/Cefepime (WCK 5222, ZaynichTM) to Treat Skull Bone Infection & Pneumonia caused by Extreme-drug Resistant Pseudomonas A recent publication highlights the multidimensional nature of antimicrobial resistance challenges in India and the need for novel versatile antibiotics to tackle growing number of multi-drug resistant infections. A publication, which recently appeared in a peer reviewed journal, European Journal of Clinical Microbiology & Infectious Diseases (EJCMID) describes an exceptionally complex case of sino-pulmonary infection and skull base osteomyelitis in a renal transplant patient caused by an extreme -drug-resistant Gram -negative bacterial pathogen, Pseudomonas. As all the available antibiotics failed to treat the infection, the patient was successfully treated with Zidebactam/Cefepi me (WCK 5222, Zaynich TM) under compassionate grounds following due approval from Drugs Controller General of India. Dr. Rajeev Soman, leading infectious diseases specialist and lead author of the publication said “Recalcitrant skull -base bone infections involving extreme -drug-resistant bugs is difficult -to- treat as the antibiotic needs to reach the site of infection in adequate concentration and the antibiotic should be active against such pathogens. The present case was even more complicated as controlli ng the source of infection through surgical intervention was not possible and the patient was severely immunocompromised. With no options left, we treated the patient with last resort combinations of Polymyxins and Fosfomycin, however the patient clinically worsened. To save this patient, we requested for Zidebactam/Cefepime under compassionate use since this antibiotic is currently in Phase 3 trials. With just few days of treatment, the patient started responding well and finally complete clinical resolut ion of infection was attained, as verified 2 months after the end of Zidebactam/Cefepime treatment ”. The scientific publication also highlighted safety of prolonged use of Zidebactam/Cefepime. Dr V Balaji, a co-author of the case study and leading clinic al microbiologist said “the pathogen from this patient was Pseudomonas aeruginosa which produced NDM enzyme capable of inactivating last-line safe antibiotic meropenem and a number of other resistance mechanisms. As a result, this pathogen was resistant t o range of newer antibiotics such Ceftazidime/Avibactam (often combined with Aztreonam), Meropenem/vaborbactam, Ceftolozane/Tazobactam, and Imipenem/Relebactam and as well as non -β-lactam class mainstay antibiotics such as Amikacin and Ciprofloxacin/Levofloxacin”. Wockhardt Limited Registered Office: D-4, MIDC, Chikalthana Aurangabad - 431006, India Tel.: +91-22-2653 4444 CIN: L24230MH1999PLC120720 www.wockhardt.com “India has become a global hotspot of antibiotic resistance and moreover, the antibiotic resistant mechanisms prevalent in India are much tougher. Transplant and cancer patients are highly vulnerable to antibiotic resistance infections due to n eed for sustained immunosuppression and frequent exposure to hospitals. In this context, novel antibiotics like Zidebactam/Cefepime are promising life -saving options for such nearly untreatable infections in our country inflicting huge mortality and morbidity,” said Dr. Rajeev Soman. About Wockhardt Wockhardt is a research based Global Pharmaceutical and Biotech company. Wockhardt’s New Drug Discovery programme has focussed on unmet need of Anti -bacterial drugs that are effective against the menace of untreatable superbugs. Wockhardt is the only comp any in the world where USFDA has given QIDP Status (Qualified Infectious Disease Product) for 6 of our Anti-bacterial discovery programmes – 3 of them are Gram Negative and 3 Gram Positive effective against untreatable “Superbugs”. It has a comprehensive Drug Discovery team and clinical organisation. Wockhardt is employing around ~ 2600 people and 27 nationalities with presence in USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities i n India, USA & UK and a manufacturing facility in Ireland. Wockhardt has a significant presence in USA, Europe and India, with 78% of its global revenues coming from international businesses.

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