Will Pfizer Outgun Merck With Oral COVID-19 Pill?

Merck, Inc. MRK is locking horns with peer Pfizer, Inc. PFE in what could be termed as the battle supremacy in the COVID-19 treatment market.

The stakes are high, with an effective treatment for the disease potentially entering the arena in addition to the vaccines that are already on the market. 

Pfizer Dips Into COVID-19 Treatment Arena: After acing the COVID-19 vaccine race along with its German partner BioNTech SE BNTX, Pfizer is wanting to leave no stone unturned in capitalizing on the COVID opportunity.

The company announced Friday an interim analysis of data from the Phase 2/3 study of its oral COVID-19 antiviral candidate Paxlovid, showing an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset.

The positive data triggered strong buying in Pfizer shares and a sell-off in Merck shares.

Merck had its share of upside in early October when it reported positive Phase 3 data for an oral COVID-19 pill, molnupiravir, that it's co-developing the treatment with Ridgeback Biotherapeutics. The Merck news triggered an across-the-board sell-off in vaccine stocks at that time.

These two companies with deep pockets and marketing expertise are vying for a piece of the COVID-19 treatment market, making the competitive landscape all the more interesting.

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Pfizer Vs. Merck Data Comparison: As opposed the 89% reduction in risk of hospitalization or death reported by Pfizer for Paxlovid, an interim analysis of Merck's Phase 3 data released on Oct. 1 showed molnupiravir reducing the risk of hospitalization or death by approximately 50%.

Only about 0.8% of patients who received Paxlovid were hospitalized through day 28 compared to 7% of patients who received placebo and were hospitalized or died.

Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset.

Merck reported that 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 compared with 14.1% of placebo-treated patients.

Through day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo. With Merck, through day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo.

Not only is Pfizer's drug safe, but the level of efficacy is so high that it will very meaningfully shake up the COVID landscape looking to next year— including the outlook for boosters, BofA Securities analyst Geoff Meacham said in a note.

"Between Roche Holding AG's RHHBY recent failure and Merck's decent efficacy, Pfizer's drug will be the clear best-in-class oral, and well positioned to capitalize on the longer term C-19 treatment market that could be in the mid-to-high billions next year," Meacham said.

Authorization Before Year-End? At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration, Pfizer will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results, the company said.

It plans to submit the data as part of its ongoing rolling submission to the authorization as soon as possible.

BofA expects the application to be soon submitted to the FDA, with an authorization likely by the end of the year.

Meanwhile, Merck announced Thursday it has received the first authorization for molnupiravir in the U.K., with the drug to be marketed under the brand name Lagevrio.

Its application with the FDA is under review. The European Medicines Agency has recently initiated a rolling review of its Marketing Authorization Application. Merck also said it is actively working to submit applications to other regulatory agencies around the world.

The commercial outlook could dramatically shift in favor of Pfizer's pill given how much more impressive the data is, BofA said. Merck's revenue guidance of $5 billion to $7 billion through 2022 provided on its third-quarter call last week could be reduced meaningfully, the firm added.

Meanwhile, Gilead, Inc.'s GILD antiviral remdesivir could remain an option for hospitalized patients, but overall its use is likely to further diminish, in BofA's view.