India-based Wockhardt has recently received US FDA qualified infectious disease product (QIDP) status for WCK 677 (currently filed Investigational New Drug Application/Clinical Trial Application (IND/CTA)) to treat complicated urinary tract infections, including pyelonephrits and intra-abdominal infections. WCK 6777 targets multidrug resistance bacterial infections where unmet need is high, translating to an untapped market opportunity, says GlobalData, a leading data and analytics company.
With the latest win, Wockhardt has become the first company globally to have granted QIDP status for six drugs in its infectious disease portfolio. QIDP status provides fast track drug development, review, and a five-year extension of market exclusivity.
According to GlobalData’s Pharma Intelligence Center, currently Wockhardt’s pipeline has nine assets for infectious diseases targeting anti-bacterials, out of which two candidates are in pre-registration, one candidate each in Phase III, II, and I, one candidate has filed for IND/CTA, and three in preclinical stage of development.
Bhavani Nelavelly, Pharma Analyst at GlobalData, says: “Wockhardt has carved out a niche by targeting specific resistant microbes in hospital setting. Due to the growing incidence of problematic Gram-negative pathogens, there is an ongoing interest in pathogen specific target rather than just the site of infection. The combination of a beta lactam inhibitor (BLI) with a cephalosporin or carbapenem are being widely tested and found to work in resistant strains. Similarly Wockhardt testing the combination of BLI with a cephalosporin (zidebactam+cefipime; WCK 5222), which is being investigated in complicated urinary tract infections (cUTI), hospital acquired bacterial pneumonia (HABP), ventilator acquired bacterial penumonia (VABP), and now the undisclosed component with zidebactam (WCK 6777) for cUTI and complicated intra-abdominal infection (cIAI) in outpatient settings.”
The patents filed for anti-bacterial drugs reported a decline of 60% globally for the last decade, whereas the anti-bacterial drugs’ patent filing by Wockhardt notably increased by 315%. As of 31 December 2019, Wockhardt filed 3,162 patents out of which 717 were granted. Wockhardt was been granted the IP rights of WCK 6777 in 2017-18 in the US.
Nelavelly adds: “Though Wockhardt has planned the global development of WCK 6777 covering the key markets including the US, EU, India and China, it is possible that the drug would initially be tested in India/China to develop insights around drug usage in outpatient/early discharge settings, and then conduct a separate trial for US/EU patients.”
Earlier, the preclinical and Phase I trials of EMROK (now launched in India) were conducted in US/EU and India, but the Phase II and III trials were only India specific, and no further development observed in the US/EU.
Nelavelly concludes: “WCK 6777 targeting MDR bacteria in out-patient setting will give the first mover advantage on commercialization in this setting, provided successful in clinical trials and expected to bypass the intense competition in hospital setting. While the US/EU pharma companies in infectious disease area are struggling to survive financially with low return on investments, Wockhardt divested its part of domestic branded business to Dr Reddy’s Laboratories for US$0.24bn to focus on development antibiotic portfolio along with chronic diseases business, earlier this year.”