India, Hyderabad; 17 March, 2022: Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, announced today that it has entered into a non-exclusive voluntary licensing agreement with Medicines Patent Pool (MPP) for manufacturing and sale of a generic version of Pfizer’s COVID-19 oral antiviral treatment candidate Nirmatrelvir, which is co-packaged with low dose Ritonavir (Nirmatrelvir; Ritonavir).
Under this licensing deal, Hetero will be allowed to expand access of co-packaged Nirmatrelvir & Ritonavir generics for COVID-19 treatment in India and in other low-and middle-income countries (LMICs), following the approvals by local regulatory agencies.
About Nirmatrelvir & Ritonavir
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. Nirmatrelvir 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 Nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
Hetero entered into a non-exclusive voluntary licensing agreement with MSD for the manufacturing and distribution of investigational oral therapeutic antiviral drug ‘Molnupiravir’ for the treatment of COVID-19. Under this licensing deal, Hetero will be allowed to expand access of Molnupiravir in India and in other low-and middle-income countries (LMICs), following the approvals for emergency use authorization by local regulatory agencies.
Hetero completed a phase 3 clinical trial (approved by CDSCO) in about 1218 COVID-19 patients, the data of which was approved by subject expert committee (SEC) and recommended for marketing authorisation. Subsequently, CDSCO provided the approval for manufacturing and marketing (M&M).