- Pfizer announced it has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for the company’s COVID-19 oral antiviral treatment candidate, which is administered in combination with a low dose of the HIV medicine ritonavir.
- Under the agreement, qualified generic medicine manufacturers that are granted sub-licenses will be able to supply the antiviral combination to 95 countries, covering up to approximately 53% of the world’s population.
- Pfizer’s pill, planned to be sold under the trade name Paxlovid in high-income countries, could fare better on the market than Merck’s molnupiravir—it was found to be more effective, and it is safer for use by pregnant recipients.
NEW YORK, NY, United States & GENEVA, Switzerland – Pfizer announced it has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for the company’s COVID-19 oral antiviral treatment candidate, which is administered in combination with a low dose of the HIV medicine ritonavir.
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, qualified generic medicine manufacturers that are granted sub-licenses will be able to supply the antiviral combination to 95 countries, covering up to approximately 53% of the world’s population.
This includes 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.
Speaking at the PING conference 2021, Ben Osborn, Pfizer UK Country Manager and ABPI President, added: “It’s not available right now, but we are currently going through the regulatory processes in the U.S., and we’ve already begun those conversations in the UK and with other bodies. The decision will now be in the hands of the regulators to assess these medicines, and we hope they will do so rapidly.
“Making the patent available to low- and middle-income countries is one that we’re really, really proud of. It’s a decision we took because the development and scale-up of a small molecule is a level of expertise that many countries have around the world, so it’s relatively easy to do with existing manufacturing plants, unlike mRNA technology, which was totally novel with no existing manufacturing facilities in place.
“With our focus on equitable access, we felt this decision was going to allow us to reach as much of the population as we could, so I really look forward to seeing that develop in years to come.”
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.
MPP inked a similar deal with Merck for its COVID-19 antiviral pill, molnupiravir, to be manufactured and sold at affordable prices in 105 countries. Both deals exclude a number of low- or middle-income nations, such as Brazil, Cuba, Iraq, Libya and Jamaica.
So far, Pfizer has not inked direct agreements with any generics manufacturers, unlike Merck.
Still, it seems Pfizer’s antiviral pill will be more accessible than its COVID-19 vaccine, Comirnaty. While the company has distributed 2 billion vaccine doses around the world, just 167 million doses landed in developing countries, and no manufacturers have been granted sublicenses to make the product.
Pfizer’s pill, planned to be sold under the trade name Paxlovid in high-income countries, could fare better on the market than Merck’s molnupiravir. It was found to be more effective, and it is safer for use by pregnant recipients.
According to Pfizer, enough pills could be produced for 180,000 people by the close of this year, and once manufacturing capacity is ramped up, at least 50 million courses could ship out in 2022, including 21 million, at minimum, in the first half of the year.
While the United States has not yet inked a supply agreement, Australia and Britain have already secured courses of the pill. Pfizer is expected to shortly apply for emergency use authorization in the United States.
Aspen Pharmacare will most likely apply for a sublicense to produce a generic version of Pfizer’s drug and sell it across Africa for approximately $10 per course, the drugmaker’s chief executive, Stephen Saad, told the New York Times.
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