Why Pfizer Is Licensing Its New Covid Pill For Poorer Countries

This appears to be a relatively inexpensive way for Pfizer to address growing demands for Covid relief in poor countries without having to sacrifice the immense profits generated by its vaccine. 

There are also competitive benefits for the company's brand umbrella since this will blunt the impact of Merck's antiviral licensing initiative. JL 

Jared Hopkins reports in the Wall Street Journal:

Pfizer is licensing  its experimental Covid-19 antiviral to a global health organization to make the pill more available to people in low- and middle-income countries. The Pfizer deal is MPP’s second for a Covid-19 therapeutic, after Merck and Ridgeback Biotherapeutics said they would license manufacturing of their antiviral, molnupiravir. 150 million adults globally could need Paxlovid. Pfizer said it would forgo royalties but afterward it will get royalties worth 5% of sales to governments and 10% of sales to the private sector

Pfizer Inc. PFE -0.10% is licensing its experimental Covid-19 antiviral to a global health organization in an effort to make the pill more readily available to people in low- and middle-income countries.

Under the licensing agreement, the United Nations-backed Medicines Patent Pool will work with other drugmakers to manufacture the pill for use in 95 countries, including in sub-Saharan Africa, Pfizer and the nonprofit said Tuesday.

MPP expects to work with at least a dozen generic drugmakers that will make supplies and thereby drive down prices for low- and middle-income countries, MPP Executive Director Charles Gore said.

“We’re not going to be handing out licenses to just anybody,” Mr. Gore said in an interview. “At the same time, we want to make absolutely certain that there is enough supply.”

The Pfizer deal is MPP’s second for a Covid-19 therapeutic, after Merck MRK 0.50% & Co. and Ridgeback Biotherapeutics LP said they would license out manufacturing of their antiviral, molnupiravir.

How Protease Inhibitors Work

Pfizer's experimental Covid-19 treatment is a protease inhibitor, a class of drugs that has proved effective against HIV, the virus that causes AIDS. Here's how they work:

1. After the virus enters a human cell, it begins making copies of itself that go on to infect new cells.

CELL

VIRUS

2. RNA from the virus contains genetic instructions for making proteins used to build the new viruses.

RNA

3. The RNA is translated into long molecules called polypeptides.

POLYPEPTIDE

4. These molecules need to be cut into smaller molecules before they can help in the assembly of new viruses. An enzyme called protease is responsible for making the cuts.

PROTEASE

PROTEASE

INHIBITOR

5. Protease inhibitors block the enzyme, preventing the new viruses from being assembled.

Source: Pfizer
 
Josh Ulick and Erik Brynildsen/
THE WALL STREET JOURNAL

Merck has also licensed out production of molnupiravir to generic drugmakers in India including Dr. Reddy’s Laboratories Ltd.

The licensing deals come as many health experts and government health officials express concern that poor countries will have less access to the antivirals than rich countries, as has happened with Covid-19 vaccines.

“The licensed territory is large and underserved by vaccine manufacturers, making inexpensive-to-manufacture therapeutics particularly important,” said James Love, director of Knowledge Ecology International, a consumer-advocacy group.

A handful of wealthy countries, including the U.S., have already secured millions of pills from either Pfizer or Merck.

The Pfizer-MPP deal can help address the gap, though Mr. Gore said supplies are unlikely to become available before mid-2022 because of the time it will take for manufacturers to scale up and for governments to clear the pills.

---

“We must work to ensure that all people—regardless of where they live or their circumstances—have access to these breakthroughs, and we are pleased to be able to work with MPP to further our commitment to equity,” Pfizer Chief Executive Albert Bourla said.

Pfizer said this month that its pill, called Paxlovid, was found in a late-stage study to be safe and reduced the risk of hospitalization or death in high-risk people with mild to moderate Covid-19 by about 89% if they took the pill within three days of diagnosis.

The pill, which is taken in combination with another antiviral called ritonavir, was also highly effective if the pills were taken within five days of diagnosis, Pfizer said.

No country has cleared for use Pfizer’s drug, which would provide doctors and patients with an easy-to-use treatment that can be used at home. Pfizer has said it plans to ask the U.S. Food and Drug Administration this month to authorize Paxlovid.

Supply will be limited initially. Pfizer projects it will be able to manufacture more than 180,000 courses of treatment this year.

Next year, Pfizer said, it can produce at least 50 million, including more than 21 million coming in the first half of the year. Yet those amounts are unlikely to meet global demand, Mr. Gore said.

As many as 150 million adults globally could need Paxlovid because of infections and close contacts, Pfizer said this month on its earnings call.

Mr. Gore said it was important to license Pfizer’s drug because there are limited data so far on the two Covid-19 antivirals, and countries may change their preferences as more data emerge.

The agreement excludes some countries that were part of the Merck deal but includes others, he said.

Pfizer said it would forgo royalties in low-income countries, including after the pandemic. It said it would also waive royalties for other countries covered by the agreement during the pandemic, but afterward it will get royalties worth 5% of sales to governments and 10% of sales to the private sector.