Wockhardt receives US FDA Qualified Infectious Disease Product designation for WCK 6777

Pharmaceutical and biotechnology major Wockhardt has received the Qualified Infectious Disease Product (‘QIDP’) designation for WCK 6777 from the United States Food and Drug Administration (‘USFDA’). WCK 6777 is a once-a-day combination antibiotic based on Wockhardt’s NCE Zidebactam, which imparts WCK 6777 novel mechanism of β-lactam enhancer. Driven by the enhancer action,the antibotic overcomes an array of problematic bacterial resistance mechanisms such as metallo-β-lactamases, KPC and OXA carbapenemases. Further, Zidebactam has the unique ability to overpower other tough resistance mechanisms such as reduced drug uptake and drug efflux encountered in contemporary multidrug (MDR)-resistant gram-negative pathogens. Being a once-a-day drug, WCK 6777 would be the first-ever antibiotic facilitating the treatment of MDR infections in out-patient settings. Wockhardt’s other Zidebactam-based product, WCK 5222, has received US FDA’s nod for global phase-three clinical trial.

WCK 6777 for injection has been awarded QIDP for the following indications:

• Treatment of complicated urinary tract infections, including pyelonephritis (cUTI)
• Treatment of complicated intra-abdominal infections (cIAI)

“Wockhardt has planned for the global development of WCK 6777 covering important markets of the US, Europe, China and India,” said Dr Habil Khorakiwala, Founder Chairman, Wockhardt Group.

The dual coveted objectives attained by this drug are the prevention of hospitalisation and the facilitation of early discharge of hospitalised patients.

The QIDP status is granted to drugs that are effective against a set of mult-idrug resistant pathogens identified by the CDC (Centre for Disease Control, USA), which have a high degree of unmet need in the treatment of patients infected by such pathogens. The status provides fast-track clinical development and review of the drug application by US FDA for approval. The QIDP drug is also entitled for five-year extension of market exclusivity. QIDP was constituted under Generating Antibiotic Incentives Now (GAIN) Act in 2012, as part of the FDA Safety and Innovation Act, to underline the urgency in development of new antibiotics.

With WCK 6777 getting the QIDP status, Wockhardt has become the only company in the world to hold QIDP status for six antibiotics emerging from its anti-bacterial discovery programme. Three of these antibiotics target gram-negative pathogens, and the other three are effective against gram-positive difficult-to- treat ‘Superbugs.’

The other NCEs of Wockhardt that have been conferred with the QIDP status by the US FDA are WCK 5222 and WCK 4282 (both targeting different gram-negative pathogens); WCK 4873 (once-a-day respiratory antibiotic active against MDR Pneumococci); and WCK 771 and WCK 2349 (broad spectrum anti – MRSA drugs). These NCEs are either in different stages of clinical development or have been approved. Earlier during the year, the Drugs Controller General of India (DCGI) had approved two new antibiotics developed by Wockhardt, EMROK ( WCK 771 IV) and EMROK O (WCK 2349 Oral), for acute bacterial skin and skin structure infections, including diabetic food infections and concurrent bacteraemia, based on the successful outcome of phase-three study involving 500 patients recruited in 40 centres across India.