DJ Merck Says Its Pill Cuts Covid Hospitalization by 50% -- Barrons.com
Merck said early Friday that it plans to submit its oral Covid-19 antiviral pill to the Food and Drug Administration for emergency use authorization "as soon as possible" after an analysis found that the drug had cut the risk of hospitalization or death by approximately 50% in a late-stage trial.
Merck (ticker: MRK) said that 14.1% of those who had received a placebo were either hospitalized or dead after 29 days, compared with 7.3% of those who had received its drug, molnupiravir. The Phase 3 trial analyzed data from 755 patients enrolled as of Aug. 5.
What's more, eight patients in the placebo group died, while none of the patients who had received molnupiravir died.
An independent data monitoring committee has recommended that recruitment into the trial be stopped due to positive results, Merck said. The trial included non-hospitalized patients with mild to moderate Covid-19 who were at risk for poor disease outcomes. The company said the trial was nearly fully enrolled when recruitment was stopped.
"With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck's unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most," said Merck's CEO, Robert M. Davis, in a statement issued Friday.
Shares of Merck were up 7.3% in premarket trading early Friday. Shares of Atea Pharmaceuticals (AVIR), which is developing a competing oral antiviral to treat Covid, were also up, jumping 28%. Pfizer stock (PFE), which is also developing its own Covid antiviral, was down 1.1%.
"We see the results as meaningful to MRK, potentially providing the company with a global blockbuster," Mizuho analyst Mara Goldstein wrote in a note published early Friday.
Experts say that an oral antiviral for Covid would have a significant impact and find a substantial market as the fight against the virus shifts to a long-term grind against an endemic threat.
The most effective therapeutics currently available for Covid, the monoclonal antibody therapies from companies like Regeneron Pharmaceuticals (REGN), GlaxoSmithKline (GSK), and others, are generally administered as an intravenous infusion, making them inconvenient for widespread use.
By comparison, Regeneron's monoclonal antibody reduced hospitalization and death by 70% in non-hospitalized high-risk patients in its own Phase 3 trial.
Molnupiravir, a pill that can be taken orally, would be a game-changer. If the FDA issues an emergency use authorization for the drug, the U.S. government has already agreed to buy 1.7 million 5-day treatment courses of the drug for $1.2 billion.
"MRK's success with molnupiravir could not only unlock over $10b in near-term orders, the pill could also represent the best option for bringing the pandemic under control worldwide," said SVB Leerink analyst Daina Graybosch in a note out early Friday.
Merck is developing molnupiravir in collaboration with a private firm called Ridgeback Biotherapeutics.
Meck said Friday that the interim analysis of the Phase 3 trial had shown that efficacy was not affected either by the timing of the onset of symptoms, or underlying risk factors, and that efficacy was consistent regardless of which variant of the virus had infected the patient.
Earlier this week, Merck presented a study at a medical conference showing that molnupiravir is active against variants as well as the original version of the virus.
In an interview on Thursday, before the company had announced the Phase 3 data, the president of Merck Research Laboratories, Dr. Dean Li, said that molnupiravir would likely work against all current and future variants of Covid-19. "The basic biology of this would suggest that all the variants that have been developed would be treated by this, suggesting that future variants would also be well treated," Li said.
Early Thursday, Merck announced a deal to acquire Acceleron Pharma (XLRN) for approximately $11.5 billion, a move aimed at shoring up Merck's pipeline after it loses exclusivity on its cancer megablockbuster Keytruda at the end of this decade. Davis, the Merck CEO, told Barron's that Acceleron's lead pipeline asset would hopefully offer revenues and earnings to help fill the hole left by Keytruda.
Molnupiravir now seems likely to play its own part in filling that revenue hole.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
(END) Dow Jones Newswires
October 01, 2021 08:29 ET (12:29 GMT)
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