R&D at Wockhardt

At Wockhardt, since 1995, discovery research has focussed on finding effective antibacterial solutions to growing therapeutic challenge imposed by AMR. Twenty five years ago, it was the visionary decision of Wockhardt’s Founder Chairman, Dr Habil Khorakiwala to embark on a journey of discovering novel antibiotics targeting multi-drug resistant Gram-positive and Gram-negative pathogens. This led to establishment of 125+ scientist multi-disciplinary team comprising of members from medicinal chemistry, in vitro microbiology, in vivo microbiology, molecular biology, drug metabolism and pharmacokinetics, safety pharmacology, toxicology, laboratory animal science, bio-analytical, intellectual property rights and regulatory affairs which began operating out of Wockhardt Research Centre, located in Chhatrapati Sambhajinagar, India. Over the years as Discovery molecules progressed from pre-clinical to clinical stages, the development team was expanded to include areas such as NCE (New Chemical Entity) scale-up, formulation development and manufacturing to deliver GMP-compliant clinical batches. To evolve end-to-end capabilities, a dedicated clinical research team based out of Mumbai, US and EU was set up to conduct clinical studies on novel antibiotics.

As a result of sustained and focussed research efforts of more than two decades, today Wockhardt boasts of an impressive pipeline of 6 novel antibiotics, with 3 already launched and 3 at various stages of clinical development. The team has filed 6 US IND’s and has been the recipient of over 400 patents during the past 2.5 decades, which is a testament to the quality of innovative research being pursued at Wockhardt. In U.S.A, Wockhardt has been granted with 69 patents. To date, more than 100 publications based on Wockhardt’s NCE programs have appeared in leading peer-reviewed journals, including the Phase 3 study of nafithromycin published in The Lancet Regional Health – Southeast Asia, with the majority of these papers authored by globally renowned independent investigators.

As a measure of its end-to-end capability in antibiotic discovery, development and commercialisation, in 2020, Wockhardt launched two novel broad spectrum anti-MRSA antibiotics, levonadifloxacin and alalevonadifloxacin in India under the brand name of EMROK and EMROK O, respectively. Until now, >130,000 patients have been successfully treated with either or both of the 2 antibiotics. Miqnaf or nafithromycin has received regulatory approval in India and is currently marketed for the treatment of community-acquired bacterial pneumonia (CABP). It provides a convenient 3-day, ultra-short monotherapy regimen designed to support better patient adherence. Wockhardt discovery pipeline includes two Phase 3 completed antibiotics [Zaynich™ (zidebactam/cefepime)], and Foviscu (2 + 2 g cefepime/tazobactam) and a Phase 1 completed, Odrate (ertapenem/zidebactam). All these candidate drugs based on their potential to address unmet needs have been granted Qualified Infectious Disease Product (QIDP) status by U.S. FDA. New Drug Application (NDA) for Zaynich has been filed in India and US as well as Marketing Authorisation Application (MAA) in Europe. Recently, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), United States of America (USA) has successfully completed Phase 1 clinical trial in US for Wockhardt’s novel once-a-day, multidrug-resistant (MDR) Gram-negative targeted antibiotic Odrate. To strengthen the scientific foundations of discovery projects, Wockhardt discovery team has stitched a strong network of global collaborators encompassing academia, industry, and contract research organizations.