The price in India would be one-tenth of the global price, said Habil Khorakiwala, chairman, Wockhardt.

Zaynich—a combination of Zidebactam and Cefepime—is effective in treating infections caused by drug-resistant pathogens. The drug is effective against all the major superbugs that have become resistant to almost all antibiotics used today—often referred to as multi-drug resistant (MDR) or extensively-drug resistant (XDR) pathogens. Globally, mortality rates in patients infected with these MDR superbugs are in excess of 30 per cent.

Earlier this month, the Clinical and Laboratory Standards Institute (CLSI) granted the drug a susceptibility breakpoint of 64 mg/litre for around ten gram-negative pathogens. The higher the breakpoint, the more effective a drug is in handling different strains. To put things in perspective, some of the recent antibiotics have a susceptibility breakpoint of 4-8 mg/litre.

Wockhardt said that this high breakpoint is proven against all three families of gram-negative pathogens: Enterobacterales, Pseudomonas, and Acinetobacter.

In over a year, Zaynich has been used to treat 30 patients under compassionate use for those who were suffering from infections caused by extreme drug-resistant gram-negative pathogens. It has not only shown a 100 per cent success rate but also been found to be safe even after prolonged use for 70 days in critical patients.

Typically, this intravenous injectable drug is administered for a week if the patient gets it in the early stages of the infection.

The drug is currently undergoing a multinational phase 3 study on 535 patients (of which recruitment of around 415 patients is done). This study is expected to be completed by 2024-25.

“Post this, it would take us four-five months to file for approval, and a USFDA approval is expected in another six months from then. Therefore, in the US and other countries, we expect to launch this drug in 2025-26,” Khorakiwala said.

Zaynich has been granted qualified infectious disease product (QIDP) status by the US Food and Drug Administration (USFDA) as it targets several critical and high-priority superbugs listed by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the USFDA. As the drug candidate addresses unmet needs in the management of difficult-to-treat infections, the USFDA has approved an abridged clinical development for WCK5222.

As for India, the launch would be earlier. Khorakiwala said that the Drugs Controller General of India (DCGI) has asked for a stringent trial on 60 patients who are resistant to meropenem. The first patient for this trial is getting recruited in a week, and the trial is expected to complete in 6-8 months. The India launch is thus likely by the end of 2024-25.

Wockhardt has spent $500 million in research and development overall in the last 25 years. The company did not share a break-up of the investments made for this drug.

However, only recently, the company spent around $25 million it raised through a QIP earlier this year on Zaynich trials. The company has also used Rs 100 crore from the QIP proceeds to retire debt, and currently, its non-working capital debt stands at Rs 300 odd crore, Khorakiwala said.

The company intends to market the drug in India and emerging markets, while it would tie up in developed markets.

First Published: Jun 28 2024 | 8:07 PM IST