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Merck looks to lower barriers to COVID-19 vaccination with oral approach

Keytruda sales grow 31% to more than $3B as pharma raises guidance

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Though Merck trails COVID-19 vaccine front-runners, Roger Perlmutter believes that using oral delivery will add a route of administration to the growing armamentarium that could give greater accessibility, in particular for older people.

The pharma is also developing an oral antiviral that will begin pivotal testing in September.

No clinical vaccine backed by Operation Warp Speed is given orally, and remdesivir, the only antiviral granted Emergency Use Authorization by FDA, is administered intravenously.

Perlmutter, an EVP of Merck & Co. Inc. (NYSE:MRK) and president of Merck Research Laboratories, said on the company’s earnings call Friday that an oral vaccine “will help to lower the barrier to vaccination.”

The pharma has started manufacturing V590 and expects to begin clinical studies in the next few months. The candidate is a recombinant vesicular stomatitis virus (rVSV) based vaccine Merck is developing in partnership with the International AIDS Vaccine Initiative.

The company has also completed clinical manufacturing of its second vaccine candidate, V591, a live attenuated, replicating measles viral vector vaccine. It plans to start clinical studies this quarter with Institute Pasteur, the vaccine platform’s inventor.

Merck gained the vaccine via its acquisition of Themis Bioscience GmbH last quarter (see “Merck Takes a Page from its Ebola Strategy”).

Both of Merck’s candidates use a replicating viral platform, which could provide some advantages over mRNA-based COVID-19 vaccines, Perlmutter said. They provide “a very potent immune stimulus” that could make a single dose feasible, and could be effective in elderly populations, which tend not to respond as well to vaccines.

Perlmutter said Merck doesn’t plan to choose one vaccine over the other, “but to instead examine the special properties of each of these very good platforms, and then to see which one needs to be taken forward first and in which population and which perhaps second, although both could be advanced simultaneously.”

HHS’s Biomedical Advanced Research and Development Authority (BARDA) is providing $38 million in early development funding for the rVSV candidate.

On the therapeutic front, Merck said it plans to start two pivotal trials of oral antiviral MK-4482 (formerly EIDD-2801) in September, one in outpatients and the second in hospitalized COVID-19 patients. Perlmutter said the pharma has secured manufacturing capacity to produce “many millions” of doses before year-end.

“There is a profound medical need for an orally active treatment to reduce the impact of COVID-19,” Perlmutter said. Because MK-4482 is “an oral drug given in capsules, it can be easily administered from the time that people have symptoms. And so that I think could mean that we could have a meaningful effect on the clinical outcomes.”

Merck is in talks with the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) consortium to begin a Phase II outpatient study of the cytosine analog, which would be run by the National Institute of Allergy and Infectious Diseases (NIAID).

The pharma obtained exclusive, worldwide rights to MK-4482 from Ridgeback Biotherapeutics LP in May, and the pair are collaborating on its development. The antiviral is in three Phase II trials in both hospitalized and outpatients in the U.S. and U.K.

The aim of the trials is to determine whether the antiviral reduces the duration of symptoms and prevents COVID-19 patients from progressing to more severe disease.

Keytruda counters COVID headwind

Despite projecting a $1.95 billion headwind from the COVID-19 pandemic this year, Merck beat expectations for the quarter and raised its full-year guidance.

“We assume that the largest impact from COVID occurred in the second quarter, with recovery having begun during the second quarter that will continue through the third quarter before a return to normal operating levels in the fourth quarter,” CFO and EVP of Global Services Robert Davis said on the call.

The pharma said sales of blockbuster cancer drug Keytruda pembrolizumab grew 31% compared with 2Q19 to $3.4 billion, beating the Street’s expectations of $3.1 billion.

EPS of $1.37 on revenues of $10.9 billion in 2Q20 topped the Street’s expectations of $1.08 and $10.5 billion, respectively.

Merck now expects full-year EPS of $5.63-$5.78 for 2020, up from its prior target of $5.17-$5.37. The company also guided for revenues of $47.2-$48.7 billion, an increase from its previous $46.1-$48.1 billion range.

Consensus figures were provided by FactSet.

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