Belgrade, Serbia 17 March 2022 –– Zdravlje A.D. (Zdravlje) announces the signing of a license agreement with the Medicines Patent Pool (MPP) for a generic version of nirmatrelvir, the novel oral COVID-19 antiviral medicine (PF-07321332) developed by Pfizer, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). This sub-license agreement is the outcome of a licensing agreement signed between MPP and Pfizer in November 2021 to facilitate affordable global access to nirmatrelvir; ritonavir.
Under the terms of the agreement, Zdravlje will have the right to develop, manufacture, supply and commercialize nirmatrelvir and ritonavir in 95 low and middle-income countries, covering approximately 53% of the world’s population.
“We are determined to make this life-saving COVID-19 treatment available to patients globally, as we partner with MPP on this important humanitarian mission”, said Kiren Naidoo, Zdravlje’s Chief Executive Officer. “This is consistent with Zdravlje’s commitment to improving access to high-quality medicines in accordance with the Human Right to Health, in this case bringing patients new treatment alternatives for COVID-19.”
About nirmatrelvir; ritonavir
PF-07321332 (nirmatrelvir) is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness which can lead to hospitalization and death. PF-07321332 is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of PF-07321332 in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
On December 22, 2021 Pfizer announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19.
On January 28, 2022 the European Commission granted a conditional marketing authorization for PAXLOVID™ for the treatment of COVID-19 following a recommendation by the European Medicines Agency’s Human Medicines Committee (CHMP). PAXLOVID™ is the first oral COVID-19 treatment to be given by mouth that is authorized in the EU for treating COVID-19.
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