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Betting big on anti-pneumonia, anti-urinary infection drug, says Wockhardt’s Khorakiwala

Updated : April 20, 2020 03:39 PM IST

WCK 6777 is Wockhardt’s sixth antibiotic drug under development, and will shortly enter phase 1 of clinical trials.

It will be another 3-4 years before the drug can be filed with USFDA for commercial use.

Wockhardt’s antibiotic for treatment of urinary tract and abdominal infections will be fast tracked for clinical developments and review by the US Food and Drugs Administrator, and also get an extended five-year exclusivity. This follows the drug, code named WCK 677, getting the Qualified Infectious disease Product Designation, a tag reserved for drugs the USFDA sees as fulfilling an unmet medical need.

WCK 6777 is Wockhardt’s sixth antibiotic drug under development, and will shortly enter phase 1 of clinical trials. But it will be another 3-4 years before the drug can be filed with USFDA for commercial use.

Wockhardt founder Habil Khorakiwala told CNBC-TV18 that it was too early to assess a market size for the drug. However, what set this drug apart from others in the same category is that it is given intravenously and needs to be taken only once a day, he said.

But Khorakiwala’s bigger bet is the drug code named WCK 5222, for treating urinary tract infection and hospital acquired bacterial pneumonia. Khorakiwala said WCK 5222 was “far superior” to WCK 6777, and a “front runner” within its drugs in the development stage. WCK 5222 will be undergoing global phase 3 clinical trials in the next three to four months, he said.

On COVID-19, the company is specifically looking at developing two drugs, Khorakiwala said. One drug uses plasma therapy and the other uses stem cells.

For the plasma therapy drug, Wockhardt has approached the DCGI for clinical trials and will also approach the Maharashtra government to use the therapy on compassionate grounds for COVID-19 positive patients. The stem cell therapy is administered to patients at critical stages such as when lung function is impacted. Countries such as China have used stem cell therapy while the US drug regulator too has approved stem cell therapy trials for COVID-19.

On the impact on its manufacturing operations because of the nationwide lockdown, Khorakiwala said his company’s Aurangabad facility has around 50-60 percent attendance. Production levels are near normal at 80 to 90 percent.

The Baddi unit Himachal however is seeing only 30 percent attendance because of the local administration disallowing full functioning.

On re-inspection of some facilities by the USFDA, Khorakiwala said the company will soon seek re-inspection of the Waluj facility which has been under Import Alert since 2013.

On the hospital business which is not part of the listed entity, he said the company’s hospital in South Mumbai which has now been sanitized will be designated as a COVID-19 hospital in a few days. The 300-bed hospital will begin with 30-50 beds allocated for COVID-19 but will have the ability to scale up if required. This South Mumbai hospital has been in the news as 80 of the healthcare staff tested positive for COVID-19.

Betting big on anti-pneumonia, anti-urinary infection drug, says Wockhardt’s Khorakiwala

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