Bloomberg: Merck & Co.’s experimental antiviral pill has the potential to unseat the handful of authorized treatments for Covid-19, that are already weighed down by questions about their effectiveness.
Results from mid-stage studies indicating the therapy’s promise could come as soon as this week, raising the possibility that a new medicine may reach the market before the end of the year. That could put the maker of Keytruda — one of the world’s fastest-selling medicines — back in the spotlight. Positive data could also assure investors that Merck has a promising pipeline beyond the cancer drug which makes up almost a third of its sales.
Since the onset of the pandemic, the focus has been on vaccines and a handful of potential treatments for the novel coronavirus. Countries around the globe are focused on stockpiling inoculations and getting them through regulatory hurdles quickly, but scientists are already saying the first vaccines may not be all that effective for very long, and treatments for the virus will still be needed.
Merck’s more measured efforts on the vaccine front mean the company trails other developers that have already entered large-scale, late-stage studies, but its experimental antiviral could be the next blockbuster treatment for Covid-19 with more than $1 billion in annual sales, one Wall Street analyst has said.
One of the early standouts in the war doctors and scientists are waging against the disease was Gilead Sciences Inc.’s remdesivir, now known as Veklury. But clinicians have yet to see Covid-19 results from either Veklury or plasma products that show a definitive benefit in extending people’s lives.
Phase 2 results from two studies of Merck’s antiviral pill — one in hospitalized patients with Covid-19 and one in outpatients — are expected in the next few weeks.
If those results “are positive and arrive in a timely manner, we believe Merck could begin phase 3 trials in September, which could support an emergency use authorization before year-end, inline with” Veklury’s approval timeline, SVB Leerink analyst Daina Graybosch wrote in a note.
The pill called, MK-4482, stops the virus from replicating. It was discovered by scientists at Emory University and is being tested with collaborator Ridgeback Biotherapeutics LP. The pill form gives it an edge over Veklury, as well as convalescent plasma, a treatment that the Food and Drug Administration has given the go-ahead for widespread use. Both need to be administered via an infusion, though an inhaled formulation of Veklury is also being developed.
Merck’s pill could offer convenience as well as greater therapeutic benefit, according to Graybosch, who pointed to the medicine’s 5-day course in non-hospitalized patients.
“MK-4482 could become the go-to option for patients who present with symptoms” even before a confirmatory test, she said drawing parallels to the flu treatment Tamiflu which peaked at roughly $3 billion in annual sales over a decade ago.
‘Millions of doses’
“We have secured manufacturing capability to produce many millions of doses of the drug before the end of this year,” Roger M. Perlmutter, president of Merck Research Laboratories, told investors on the company’s second-quarter earnings call last month. The medicine also appeared active in lab tests against viruses with mutations that made them resistant to Veklury, he said.
Merck plans to kickoff two new pivotal trials in September, one for outpatients and one for those hospitalized. A large phase 2 outpatient study under the auspices of the National Institute of Allergy and Infectious Diseases is also in the works.
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