
Pharmaceutical R&D Developer
Cailian Press (Shanghai, Editor: Shi Zhengcheng) reported that on Friday local time, global pharmaceutical leader Pfizer announced that the combination of its protease inhibitor PF-07321332 and the antiviral drug ritonavir (collectively known as Paxlovid) reduced the risk of hospitalization or death by 89% in clinical trials involving patients with mild to moderate COVID-19 and underlying medical conditions.
This is also the second drug, following Merck, proven to significantly reduce disease progression in COVID-19 patients. Yet, amid the jubilation in global capital markets, the most pressing question has become how much it will cost to access this new medication.
Although Pfizer has not directly disclosed the pricing, CEO Albert Bourla clearly stated in a media interview on Friday that the company is currently negotiating the supply of Paxlovid with 90 countries. For high-income nations, the anticipated price is expected to be comparable to that of Merck’s oral COVID-19 drug, molnupiravir. According to prior disclosures by the U.S. government, a five-day course of molnupiravir, administered as four capsules twice daily, carries a total cost of $700. Bourla also noted that for low-income countries, the company is evaluating alternative options, with the overarching goal to “ensure these countries have unimpeded access to the medication.”
In addition to the high unit price, whether the production capacity of oral COVID-19 drugs can meet global demand is itself a concern.
Although Pfizer expects to submit clinical trial data to the FDA only by the end of this month, the robust efficacy that justified the early termination of the trial indicates that the company is highly confident in securing an Emergency Use Authorization (EUA) before year-end. U.S. President Biden also explicitly stated on Friday that the country has already secured millions of "Pfizer's oral pills," which further implies that the 180,000 treatment courses Pfizer anticipated producing this year have been completely snapped up, with the company projecting its production capacity to reach 50 million treatment courses in 2022. The UK government has also disclosed that it has ordered 250,000 treatment courses from Pfizer. Pfizer's Paxlovid requires a regimen of three pills taken in the morning and three in the evening for five consecutive days.
Previously, the U.S. government also committed $1.2 billion to pre-order 1.7 million treatment courses of molnupiravir from Merck, with the company currently estimating its production capacity at 10 million courses this year plus 20 million courses next year.
For the vast number of low- and middle-income countries, an oral medication priced at $700 per treatment course is clearly insufficient to enable them to treat "COVID-19 as the flu." Beyond hoping for differential pricing by pharmaceutical manufacturers, the UN-backed Medicines Patent Pool (MPP) has become the only hope.
On October 27, Merck reached an agreement with the Medicines Patent Pool (MPP) to authorize other manufacturers to produce generic versions of molnupiravir on a royalty-free basis for supply to 105 low- and middle-income countries. Previously, experts estimated that the price of generic drugs could drop to as low as $10 per course of treatment. In a media interview this week, Charles Gore, Executive Director of the MPP, stated that many pharmaceutical companies have already expressed interest, including manufacturers from China, India, and Pakistan.
It should be noted that China is not among the 105 countries covered by the MPP agreement, which means that even if Chinese pharmaceutical manufacturers obtain generic drug licenses, medicines produced through this channel cannot be directly sold to the Chinese market.
Of course, the hope of containing the pandemic through oral medications does not rest entirely on Pfizer and Merck. Based on prior development progress, Roche’s polymerase inhibitor AT-527 and Kintor Pharma’s androgen receptor (AR) antagonist proxalutamide are also expected to announce their Phase III clinical trial results in the fourth quarter.