… Merck is launching 3 COVID-19 business initiatives …


Development of 2 vaccines and an oral antiviral agent are key elements in Merck’s COVID-19 business plans


John G. Baresky

Kenilworth, New Jersey-based Merck (NYSE: MRK) has launched a 3-prong business initiative to combat COVID-19 and once again demonstrate its clinical and competitive mettle in global healthcare. Their strategy is centered on spearheading the development of two vaccines and one antiviral agent.

Merck and Ridgeback Biotherapeutics LP Partnership

Merck and Ridgeback Biotherapeutics LP have joined forces to develop an oral antiviral agent to treat COVID-19. The investigational compound EIDD-2801 is an early-stage ribonucleoside analog with activity against the replication of multiple viruses including SARS-CoV-2/COVID-19.

Based in Miami, Ridgeback Biotherapeutics was founded in 2015. It is privately held and specializes in the development of medicines and diagnostics for underserved patient populations including pediatric orphan drugs and emerging infectious diseases.

Besides its collaboration with Merck, Ridgeback is partnered with the NIH: National Institute of Allergy and Infectious Diseases Vaccine Research Center to develop mAb114 — a late-stage experimental treatment for Ebola. Merck is the first company to commercialize and launch an Ebola vaccine, Ervebo, which received FDA and European regulatory approval in 2019.

Merck and International Aids Vaccine Initiative (IAVI)

IAVI is a nonprofit scientific research organization that Merck is collaborating with to develop a COVID-19 immunization. The vaccine being developed uses the recombinant vesicular stomatitis virus (rVSV) technology that Merck utilized to create its Ervebo ebola vaccine.

As added support, Merck has signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA) which will provide early financing in the initiative to get it underway. Founded in 1996, IAVI is based in New York City.

Merck goes all-in against COVID-19 and acquires Themis Bio

Merck is bypassing collaboration and partnership opportunities in this part of its COVID-19 strategy by acquiring Vienna, Austria-based Themis Bioscience GmbH. Founded in 2009, Themis is largely focused on the research and development of new vaccines and a small group of advanced, early-stage cancer therapies.

Much of its work is based on using its measles virus vector platform (that was created by researchers at the Institut Pasteur which licensed it exclusively licensed to Themis) to create new immunological and biotherapy products.

The company already has a COVID-19 collaboration underway with Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh (PITT) that is financed by the Coalition for Epidemic Preparedness Innovations (CEPI).

The Themis pipeline includes immuno oncology and vaccine candidates which align well with Merck’s present and future clinical focus and business strategy. No doubt Merck included these value-added attributes in their decision to acquire Themis outright.

Merck is up for the challenge

Some industry observers assert that Merck is late to the game when it comes to entering the COVID-19 market sector and that is not the case. Merck has significant experience with the development of successful vaccines including Ervebo (ebola), Gardasil-9 (HPV), RotaTeq (rotavirus) and many others. It has the experience and knowledge in the healthcare commercial and clinical research sectors to close the gap against competitors if necessary.

Merck has ample financial and intellectual resources coupled with extensive global healthcare leadership it can bring to bear when necessary to accelerate discovery and implement clinical trials. It can deploy these assets as they wish and when the time comes following regulatory approval, apply its commercial and market access savvy to launch products successfully.

Another factor in the timing of Merck’s entry into the COVID-19 market is it has a major corporate divestiture initiative underway. Just as the world was being introduced to COVID-19, Merck announced it was spinning off its biosimilar, women’s health and established legacy products as a separate, publicly held company.

It has also recently communicated it is selling its StayWell unit to WebMD/Internet Brands that is owned by KKR. The combination of these two divestitures required careful attention upfront as Merck was formulating its COVID-19 strategy.

Merck’s successful 2020 and future business strategy is well underway

Merck concluded 2019 with the FDA and European regulatory approval of Ervebo. They generated over $47 billion in sales over 2019 and it is well-positioned to continue its growth and leadership with these 3 COVID-19 initiatives underway.

It kicked off 2020 with its assertive corporate divestiture strategy followed by Keytruda’s and Padcev’s (Seattle Genetics) bladder cancer FDA breakthrough designation and then the FDA approval of Merck’s and AstraZeneca’s Koselugo neurology and oncology product.

By having two vaccine candidates and an antiviral therapy underway, Merck can hedge its bets. Its acquisition of Themis is good for its long term plans as oncology and vaccines are two of the business franchises Merck is not spinning off and plans to further invest in. The antiviral agent is something that has great potential in the event vaccines being developed worldwide are not successful or do not deliver complete or long term immunogenicity.

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