Page 154 - CW E-Magazine (9-7-2024)

Pharmaceuticals

DRUG DEVELOPMENT
Wockhardt aims to launch antibiotic with $25-bn

market potential by early FY26

Wockhardt said research and trials on lection of the most effi cacious antibio- antibiotic. Dr. Khorakiwala said that
its investigational antibiotic, Zaynich, tic for treating various infections caused antibiotic resistance levels are as high
are progressing satisfactorily, and it by different pathogens. A high break- as 60 percent locally and at an elevated
is aiming for an early FY26 launch. point of 64-mg/L suggests Zaynich’s 35 percent globally which makes it a
Zaynich has a market potential of $25-bn, strong potential to cover all the clini- decent opportunity. The antibiotic is
according to the company’s founder cally important, extreme drug resistant showing effi cacy in both treatment and
Chairman Dr. Habil Khorakiwala. gram negative pathogens in seriously ill safety in the trials, he claimed.
patients,” it added.
The company has invested over The company used $25-mn from
$500-mn on its research efforts till Dr. Khorakiwala said the company a recent Rs. 480-crore equity capital
now, which have yielded six successes, expects the fi nal approvals from the raise towards the research and
including Zaynich which are at Indian regulators to launch the antibiotic development of Zaynich, while
different levels of development and by the end of FY25 and will soon be Rs. 100-crore was utilised to reduce the
marketing, he said. Currently, Zaynich launching it commercially after that. debt. The external debt stands at about
(Zidebactam/Cefepime-WCK 5222) For the developed markets as well, the Rs. 900-crore, of which Rs. 500-crore
is undergoing a multinational phase company expects approvals to come in is for working capital purposes, Dr.
3 study. Zaynich has been granted a similar timelines or maybe with some Khorakiwala said, stressing that it is
susceptibility breakpoint of 64-mg per lag, he said, outlining the commer- comfortable from a liquidity stand-
litre for around 10-gram negative patho- cial strategies. In India, the company point. Apart from this, the company has
gens showing high resistance rates by plans to sell the antibiotic at a tenth also borrowed Rs. 1,000-crore from
the American Clinical and Laborato- of the price in developed markets, and the promoter Khorakiwala family,
ry Standards Institute, according to a will primarily be targeting pneumonia he said, adding that the family is com-
company statement. Explaining this, patients, he said. In the developed fortable and not in a hurry for repay-
the company said, that susceptibility markets, it will be looking for partners ments, especially given the business
breakpoints guide the doctors about se- willing to establish networks to sell the opportunity it sees.
POOR RECORD
Over a third of inspected drug units ordered to be

shut: Regulator

More than 36% of the 400 drug be closed”. The issues in the Indian inspected 400 manufacturing units,
manufacturing units inspected since pharma industry relate to “non-com- most of them MSMEs. The teams
last year were ordered to be shut, pliance which leads to quality issues,” also audited drug testing laboratories.
according to the country’s drug regu- he told an event in Mumbai. Mr. Raghuvanshi said inspections
lator, Central Drugs Standard Control have found lapses in process valida-
Organisation (CDSCO). Mr. Raghuvanshi, who took over tion, poor documentation, and many
as CDSCO chief in February 2023, smaller units didn’t have full-fl edged
In a Reuters report, the Drug is trying to restore the reputation of quality control labs, and were using
Controller General of India (DCGI), made-in-India medicines, battered by external labs.
Mr. Rajeev Raghuvanshi, was quoted scores of child deaths in Uzbekistan
as saying that after one and a half and Gambia, linked to the consump- “Some of them decided to move
years of inspections, he was “not very tion of tainted cough syrups by Indian out (of manufacturing); they have
happy to say that more than 36% of manufacturers. As part of the mas- realised that they cannot meet the
them (manufacturing units) had to sive crackdown, CDSCO teams have expectations of the regulator,” he added.

154 Chemical Weekly July 9, 2024

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