Pfizer to file for emergency authorization Tuesday for its Covid-19 pill

In an anticipated move, Pfizer (PFE) chief executive officer Albert Bourla said the company plans to ask the U.S. Food and Drug Administration on Tuesday to authorize emergency use of its antiviral pill for combating Covid-19.

Bourla announced the company’s intention to file at the 2021 STAT Summit, and the company formally made its request later on Tuesday. The step comes shortly after the company reported its pill, called Paxlovid, reduced hospitalizations by 89% among patients who started within three days of symptoms and also prevented deaths in a large, randomized study. The disclosure followed news from Merck (MRK) that its own pill reduced hospitalizations by 50%, although data was not shared on patients treated within three days of symptoms.

While neither drug maker has released complete study data, the one-two punch of top-line announcements generated considerable enthusiasm that helpful tools may finally become available to tame the coronavirus, which has claimed more than 760,000 lives in the U.S., according to the Centers for Disease Control and Prevention.

The Pfizer pill is given as a five-day course, and must be combined with a second medicine called ritonavir, which is made by AbbVie (ABBV). The Pfizer regimen involves taking 30 pills over a five-day period. For now, the cost is unclear, although Pfizer has signaled it will sell its treatment directly at a price comparable to what Merck charges for its own pill, which sells for as much as $750 in Japan.

The Biden administration is expected to announce this week that it is purchasing 10 million courses of the Pfizer pill, according to The Washington Post. The price struck between the administration and Pfizer for its drug is less than for the Merck pill — closer to $500 per treatment, although administration officials say the final details are not done.

The agreement has the potential to generate anywhere from $15 billion to $25 billion in sales in 2022, if the pricing holds between $300 and $500 a treatment course – and 90% of those are distributed, according to Barclays analyst Danielle Popper.

Elsewhere, Pfizer has signed a licensing agreement with the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide generic versions of the drug to 95 low and middle-income countries. The pricing will be determined by the generic companies, but the move comes amid mounting on pressure on drug makers to widen global access to Covid-19 medical products.

Meanwhile, Pfizer has suggested its pill may eventually be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults. However, it is worth noting that ritonavir can cause serious interactions when combined with other medicines.

The Merck pill drew scrutiny after the company signed a $1.2 billion deal to supply the U.S. government with 1.7 million doses, which works out to a $712 unit cost for a five-day treatment course, according to the contract. But the actual manufacturing cost for a five-day treatment course is estimated to be $20.

However, the Merck pill was developed with support from the federal government before it was licensed to Emory University, which later licensed it to Ridgeback Biotherapeutics, Merck’s development partner. This opens the door to debate over the price the U.S. government should pay for a badly needed treatment developed, in part, with taxpayer dollars.