Strides Pharma Science has signed a sub-licence agreement with Medicines Patent Pool (MPP) for the marketing of a generic version of Pfizer’s Covid-19 oral drug.
The oral antiviral treatment is an inhibitor of SARS-CoV-2 main protease developed by Pfizer.
It comprises nirmatrelvir tablets that are packaged and administered together with ritonavir tablets.
Administered twice daily, the treatment consists of a 300mg dose of nirmatrelvir and 100mg tablet of ritonavir.
The drug has obtained emergency use authorisation as Covid-19 oral therapy in the US as well as various other countries for usage in adults and paediatric patients who are at increased risk.
The generic version of Pfizer’s oral therapy will be branded as Kovidax and supplied to 95 low and middle-income markets through the agreement with MPP.
Strides noted that Kovidax will be produced at its site in Bengaluru, India.
The company has obtained the supplies of the active pharmaceutical ingredients (API) required for manufacturing under a preferred collaboration deal.
Strides Pharma Science Founder Arun Kumar said: “Kovidax is the latest addition to our Covid care portfolio and is part of our commitment to producing high-quality medicines to fight the challenges of Covid-19 outbreak around the world.
“We are glad to collaborate with MPP to commercialise the generic version of the Pfizer product and reach out to the global markets.”
According to results from the Phase II/III EPIC-HR trial, the oral drug was demonstrated to reduce hospitalisation or mortality risk from any cause by 89% within three days of symptom onset versus placebo.
The US Food and Drug Administration granted EUA for the oral antiviral based on data from this trial.