Friday, October 1, 2021

Another Good NYSE Day, For Merck: Emergency Use Authorization To Be Sought, For Ridgeback / Merck's Molnupiravir (MK-4482) COVID-19 Pill...


This is now two strong days in a row, of great news for Merck. And while the MK-4482 candidate pill has, when given early, reduced the rate of death by about 50 per cent in smallish early clinical trials, I'd expect that data here to hold up, more generally. So this really is a breakthrough -- to have a proven highly effective, and oral, medication -- for COVID-19 therapy.

I am not certain that it should increase Merck's NYSE stock price by nearly 10 per cent (now, ~8.5% in late afternoon trading), in a single day, though. I suppose one might argue that Merck was undervalued, before today -- and the dam has broken. . . but I don't really think a stock as widely followed as Merck is ever really trading without all the information in the price.

And to make my point, more directly -- the price pressure on this pill, as it comes out of the gate -- assuming FDA clears it -- and FDA will. . . will be extraordinary. In much of the still-developing world, it will need to be essentially given away (likely ultimately as A WHO "essential medicine").

Bear in mind, that we have reached 700,000 deaths in the US, alone -- and over five million, globally. This is a pandemic event, unlike any we've seen in over a century.

And so, a pill that cuts those grim tallies in half. . . well, it will be. . . in demand, everywhere -- but not at hundreds of dollars, per dose. [Perhaps not even at tens, per dose.] We shall see. It is great news, for humanity, and Merck -- but it is unlikely that Merck / Ridgeback will be able to command monoclonal antibody (i.e., Regeneron-level) pricing. Still -- here is the good news:
. . .[Merck and Ridgeback Bio] announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. . . .

At the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide. . . .


We shall, as ever, see. But Merck is no doubt (once again -- post about 2012) a great company. Smart and increasingly agile, in its reactions to changing markets. And ethical, in saving lives. Smiling. . . ever. . . smiling.

नमस्ते

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