New Delhi: Drug firm Wockhardt expects its several new antibiotic drugs that are under development as positive factors that will impact the shape of things to come, according to the company's Founder Chairman Habil Khorakiwala.
In his address to shareholders in the Annual Report for 2018-19, Khorakiwala said the company has several new chemical entities (NCEs) which are being developed as antibiotic drugs that are at various stages of clinical trials. "I believe that the development work on these drugs today will shape the global war on Antimicrobial Resistance (AMR) tomorrow," he added.
Khorakiwala said Wockhardt's NCE, WCK 4282, has been acknowledged by Chinese regulator National Medical Products Administration (NMPA) that the product would address unmet needs in China. Accordingly, China would be a part of the global Phase III cUTI (complicated urinary tract infection) study.
He further said another NCE, WCK 4873, has obtained India phase 3 CABP (Community-acquired Bacterial Pneumonia) study approval from the country's drug regulator Drug Controller General of India (DCGI). The study will commence in the third quarter of 2019.
Yet another NCE, WCK 771/WCK 2349, has completed India phase 3 acute bacterial skin and skin structure infection (ABSSSI) study and the New Drug Application (NDA) is under review by the Investigational New Drug (IND) committee, Khorakiwala added.
Lastly, for NCE WCK 6777, the United States Food and Drug Administration (USFDA) has accepted IND for a unique once-a-day MDR (multi-drug resistant) gram-negative product. "All these developments are positive factors that will impact the shape of things to come," Khorakiwala said.
Commenting on regulatory compliance issues, he said, "while we are still facing compliance challenges in a couple of our manufacturing facilities in India, we have invested significantly in people, processes, training and technology to address them."
The commitment is absolute and the measures are ongoing, he said. "We expect to shape up and achieve full regulatory compliance at the earliest," Khorakiwala asid without elaborating on timelines.
