Amneal Pharmaceuticals announced it has been awarded a sub-license from the Medicines Patent Pool (MPP) to manufacture and commercialize a generic version of nirmatrelvir, co-packaged with ritonavir, in 95 low- and middle-income countries. Nirmatrelvir is an oral protease inhibitor co-packaged with ritonavir for the treatment of mild-to-moderate COVID-19.
Pfizer markets co-packaged nirmatrelvir and ritonavir in the United States and other countries as PAXLOVIDTM. The phase 2/3 Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial conducted by Pfizer demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVIDTM, compared to placebo, within three days of symptom onset. The U.S. Food and Drug Administration (FDA) granted PAXLOVIDTM emergency use authorization (EUA) in December 2021.
To increase equitable access for this therapy, Pfizer has entered into a license agreement with the MPP to sub-license the manufacture of generic versions of nirmatrelvir, as well as the commercialization of co-packaged nirmatrelvir and ritonavir, to multiple pharmaceutical companies committed to providing the product to 95 low- and middle-income countries.
Amneal plans to manufacture nirmatrelvir in India and already owns an internally developed, FDA-approved generic version of ritonavir, which will be manufactured in both the U.S. and India. Amneal is working to bring the co-packaged combination to these impacted countries starting in 2023.
“Amneal has always held a deep commitment to provide access to affordable essential medicines and address unmet patient needs. This is a distinct opportunity for us to fulfill this mission on a global basis,” said Chirag and Chintu Patel, Co-Chief Executive Officers. “Nirmatrelvir and ritonavir have the potential to help address the pandemic in a way we have not seen before, and we are honored to contribute to the global manufacture and distribution of generic versions of these important therapies.”
“As we grow our commercial business in India, we expect this will be an anchor product for us,” continued Messrs. Patel. “And the opportunity is even greater than that. The 95 countries in the license territory represent over half the world’s population. We, together with other MPP licensees, have the potential to provide hundreds of millions of doses of this COVID-19 treatment to patients around the world who need them.”
