New Delhi: Strides Pharma Science on Monday said it has inked a sub-license agreement with Medicines Patent Pool to commercialize a generic version of Pfizer's COVID-19 oral treatment drug in 95 low and middle-income markets. The Pfizer product has been authorized as a COVID-19 oral therapy for emergency use in the US and other countries for high-risk adults and pediatric patients.
Branded as Kovidax, Strides' generic version of the Pfizer oral treatment will be launched in 95 markets as part of the sub-licensing agreement with Medicines Patent Pool (MPP), the drug firm said in a statement. The product will be manufactured at the company's Bengaluru plant, and it has already secured its active pharmaceutical ingredients (API) supplies through a preferred partnership arrangement, Strides Pharma added.
"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 commercialize the generic version of the Pfizer product and reach out to the global markets," Strides Pharma Science Founder Arun Kumar said.
The company's forte lies in scalability and affordability, and it is hopeful of maximizing the reach for Kovidax in a short period, he added. The Pfizer COVID-19 oral treatment has reduced the risk of hospitalization or death for any cause by 89 percent within three days of symptom onset compared to placebo. It is administered as a dose of 300 mg of nirmatrelvir with a 100 mg tablet of ritonavir, given twice daily for five days.
The FDA's emergency use authorization for the oral treatment is based on the clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial conducted by Pfizer.
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