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Merck & Co., Inc. MRK announced that it has reached an agreement with the U.S. government to manufacture and supply its investigational biological therapeutic, CD24Fc (to be named MK-7110), which is being developed for treating patients seriously affected by COVID-19.
Merck is collaborating with the U.S. government to supply approximately 60,000-100,000 doses of MK-7110, upon potential approval or an Emergency Use Authorization (“EUA”) from the FDA.
Per the agreement, Merck will be eligible to receive up to $356 million for supplying said doses of MK-7110 through June 30, 2021 to the U.S. government to meet the latter’s Operation Warp Speed goals.
Shares of Merck have decreased 12.3% so far this year, against the industry’s increase of 0.9%.
We remind investors that Merck added MK-7110 to its portfolio following the acquisitionof private biotech OncoImmune for an upfront cash payment of $425 million in November 2020. The candidate is currently being evaluated in a phase III study for treating severe and critical COVID-19.
Notably, top-line data from an interim analysis of the phase III study showed that treatment with MK-7110 led to 60% higher probability of improvement in clinical status of patients with severe or critical COVID-19 versus placebo while reducing the risk of death or respiratory failure by more than 50% in such patients.
This apart, Merck is developing an orally available antiviral candidate, molnupiravir, in collaboration with Ridgeback Bio for treating COVID-19 patients. Two pivotal studies are evaluating the candidate in non-hospitalized adult COVID-19 patients or hospitalized adult COVID-19 patients.
We note that, over past couple of months, the FDA has given EUA to several treatments for severe illness caused by SARS-CoV-2.
In November 2020, the FDA gave EUA to Regeneron’s REGN antibody cocktail, casirivimab and imdevimab, administered together (formerly known as REGN-COV2 or REGEN-COV2) for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
Also, in November 2020, the FDA granted EUA to Eli Lilly’s LLY antibody drug, bamlanivimabas, a monotherapy for the treatment of recently diagnosed mild-to-moderate COVID-19 illness in patients who are at high risk of progressing to severe COVID-19 or hospitalization.
The FDA also granted EUA to Lilly and Incyte’s INCY oral JAK inhibitor, Olumiant, for use in combination with Gilead’s remdesivir in hospitalized COVID-19 patients based on positive phase III results from the ACTT-2 study in November 2020.
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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