Cipla brings Gilead’s remdesivir generic to SA

Organisation: Position: Deadline Date: Location:

Indian drug manufacturer Cipla is set to bring its generic version of Gilead Science’s coronavirus drug remdesivir to South Africa within the next few weeks, a study from the universities of Witwatersrand, Cape Town and Stellenbosch estimates this could increase the number of patients that intensive care units (ICUs) can handle by more than 50%.

has emerged. Remdesivir is the first drug to have been approved by US authorities to treat COVID-19 and has been shown to speed up the recovery of hospitalised patients.

Business Day reports Cipla plans to sell the drug at $55 a shot, or $330 (R5,600) for a five-day course, according to Cipla SA CEO Paul Miller. This is considerably lower than the $520 a vial price tag Gilead has set for US patients with private insurance. Patients start with a double dose on the first day, and then go to a vial a day.

Gilead, which holds the patent on remdesivir, has restricted sales of its drug to the US for the next three months, but has granted non-exclusive manufacturing licences to several generic pharmaceutical companies, including Cipla, which has a well-established presence in South Africa.

Cipla has earmarked an initial batch of 35,000 vials for South Africa, which should arrive in the country in the week of 20 July, Miller is quoted in the report as saying. Gilead’s deal with generic manufacturers is royalty-free until the World Health Organisation says COVID-19 is no longer a global health crisis, or when another drug or vaccine is approved for the disease.

Remdesivir has not yet been registered by the SA Health Products Regulatory Authority (Sahpra), so it will have to be imported using a section 21 exemption to the Medicines and Related Substances Act, Miller said. Section 21 exemptions are routinely used to import medicines that have not been scrutinised by Sahpra but have been approved by regulators in other countries.

Miller said remdesivir will be manufactured at Cipla’s Goa site in India, which is approved by the US Food and Drug Administration and Sahpra, as the company does not have the capacity to make it in South Africa .

 

Recent research has suggested remdesivir can reduce COVID-19 deaths by up to 30%. It also reduces intensive care stays from 15 days to 11, on average. And, The Times reports, a study involving scientists from the University of the Witwatersrand, University of Cape Town and University of Stellenbosch has estimated this could increase the number of patients that intensive care units (ICUs) can handle by more than 50%.

The study said the increased capacity could save up to 6,862 lives as cases peak. Added to the lives that could be saved directly by remdesivir treatment, they said the drug could prevent the deaths of 13,674 South Africans by December.

“There are many countries with limited ICU capacity that could benefit from this double impact on mortality,” said the study’s lead author, Brooke Nichols, from the health economics and epidemiology research office at Wits.

The report says South Africa has about 3,450 ICU beds for coronavirus patients, and capacity is expected to run out in some provinces for months at a time as the coronavirus spreads. “Without remdesivir, it is expected that 23,416 to 31,269 people will occupy an ICU bed during peak months when ICU capacity is expected to be breached,” the study said.

“By giving remdesivir to all patients in ICU during peak months, 3,295 to 6,814 deaths will be averted, assuming an 85% death rate among those not receiving ICU care but who require this care.” Between 4,707 and 9,734 deaths would be averted if the assumption was altered to a 100% death rate among those not receiving ICU care but requiring it.

Abstract
Countries such as South Africa have limited intensive care unit (ICU) capacity to handle the expected number of COVID-19 patients requiring ICU care. Remdesivir can prevent deaths in countries such as South Africa by decreasing the number of days people spend in ICU, therefore freeing up ICU bed capacity.

Authors
Brooke E Nichols, Lise Jamieson, Sabrina RC Zhang, Sheetal Silal, Juliet Pulliam, Ian Sanne, Gesine Meyer-Rath

 

Full Business Day report

 

Full report in The Times

 

medRxiv abstract

Receive Medical Brief's free weekly e-newsletter



Related Posts

Thank you for subscribing to MedicalBrief


MedicalBrief is Africa’s premier medical news and research weekly newsletter. MedicalBrief is published every Thursday and delivered free of charge by email to over 33 000 health professionals.

Please consider completing the form below. The information you supply is optional and will only be used to compile a demographic profile of our subscribers. Your personal details will never be shared with a third party.


Thank you for taking the time to complete the form.