Pfizer, US Gov’t in $5.29-Bn Pact for Oral COVID Drug

Pfizer has entered into an agreement with the US government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate, Paxlovid, in a deal worth up to $5.29 billion.

Under the agreement, the US government will acquire 10 million treatment courses to be delivered by Pfizer beginning later this year (2021) and concluding in 2022. Pfizer will receive $5.29 billion from the US government, pending and contingent upon regulatory authorization.

Pfizer is seeking emergency use authorization of Paxlovid in the US. Rolling submissions have also begun in several countries, and the company says it will continue working to submit applications to regulatory agencies globally.

The price for Paxlovid being paid by the US government is reflective of the committed volume of treatment courses being purchased through 2022. Pfizer has also entered into advance purchase agreements with several other countries and has initiated bilateral outreach to approximately 100 countries globally.

Separately, Pfizer and the Medicines Patent Pool (MPP), a United Nations-backed public health organization, have signed a voluntary license agreement for the drug, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection.

The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.

Under the agreement between Pfizer and MPP, qualified generic medicine manufacturers globally that are granted sub-licenses will be able to supply Paxlovid in combination with ritonavir to 95 countries, including all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years (as reported on November 16, 2021).

Pfizer will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a public health emergency of international concern by the World Health Organization.

Source: Pfizer (US pact), Pfizer (EUA), Pfizer (MPP pact), the US Department of Health and Human Services, and the Medicines Patent Pool