Cipla to bring generic of Covid-19 treatment remdesivir to SA
Indian drug manufacturer Cipla is set to bring its generic version of Gilead Science’s coronavirus drug remdesivir to SA within the next few weeks, it emerged on Thursday.
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.
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 SA.
The US has confirmed more than 2.6-million cases of Covid-19, more than any other country in the world. SA is grappling with a growing epidemic, which by Wednesday had spurred the official number of cases to more than 159,000 and the death toll to 2,749.
Cipla has earmarked an initial batch of 35,000 vials for SA, which should arrive in the country in the week of July 20, Miller said.
“There is an acute requirement, so we have to get the product to market as quickly as we can,” he said. “It is probably a short-lived product, of six to eight months. We [expect] a vaccine could well become available in the new year, when the role of a product like remdesivir will become obsolete,” he said.
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 SA.
A recent local review of remdesivir did not provide any strong evidence that it reduces mortality, and its main benefit is a shortened duration of hospitalisation, the department of health’s Anban Pillay said. “The ministerial advisory committee was not enthusiastic about it until there is more evidence,” he said.
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