Buoyed by the positive results of its antibiotic nafithromycin (WCK 4873) to treat pneumonia, drugmaker Wockhardt expects to file for regulatory approvals in India and subsequently scout for licensing partners to supply the drug in emerging markets.
In fact, with a pipeline of promising antibiotic candidates, Wockhardt Chairman Dr Habil Khorakiwala said, a similar strategy would be adopted for all of them — with the company retaining the India supply business and licensing other pharma companies for outside markets.
Dr Khorakiwala told businessline that “a combination of competence, networking and a little bit of luck” contributed to the positive developments in the company’s antibiotic pipeline. The company has invested about $350 million in drug discovery over two decades, and six of its antibiotic candidates have the qualified infectious disease product (QIDP) status from the US Food and Drug Administration, he said. (This helps fast-track development of treatments for life-threatening infections caused by drug-resistant organisms.)
Just this week, Wockhardt informed stock exchanges that it had completed late-stage Phase III trials on nafithromycin, comparing it to the last-line respiratory antibiotic moxifloxacin. The studies showed that a three-day treatment with nafithromycin was as effective as a seven-day course of moxifloxcain, among other findings, Wockhardt had said, terming it a major breakthrough in 30 years of pneumonia treatment.
Khorakiwala said that the Phase III trials were done in India, involving over 500 patients. But the earlier stages of the trial were held in the US and Europe. With plans to seek regulatory approval for the drug shortly, the company expects to launch it in India mid-2024, and globally about a year later, he said.
Wockhardt is also seeking regulatory approvals for another antibiotic, WCK 5222, for clinical trials in people with drug resistance, he said. Phase III trials for this drug is expected to conclude mid-2024, but positive outcomes were already seen in a few cases where it was allowed to be used on compassionate grounds.
Khorakiwala also cited WCK 6777, which underwent early-stage Phase I trials in the US in collaboration with the National Institutes of Health.
Newer diabetes treatments
Wockhardt was reportedly earlier scouting for partners in its India business, but no longer, Dr Khorakiwala said, with growth anticipated to be driven by its biologics- and antibiotics-linked segments. An early participant in the diabetes segment, the company would look at newer treatment and insulins, he said.
Separately, it will continue to look for contract manufacturing opportunities in vaccines and was in talks with a vaccine company. Wockhardt currently has a multi-vaccine tie-up with Serum Institute of India for 15 years, and has identified two vaccines to make for them.