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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

COVID-19 SPECIAL REPORT #20.18

Merck makes major moves to enter the COVID-19 arena

Merck, one of the largest and most innovative biopharmaceutical company, announced a triple play to enter the COVID-19 arena. Merck, a major vaccine producer with worldwide sales of $8.4 billion in 2019, had been very quiet on the COVID-19 front. In fact, the company was working on the problem, but it was simply not ready to speak.

On May 26, the US based biopharmaceutical giant announced plans to acquire Themis, an Austrian company, to enter a partnership with IAVI and to license an orally active anti-viral from Ridgeback Biotherapeutics.

“We are committed to making a contribution to the eradication of COVID-19” said Roger Perlmutter the President of Merck Research Laboratories.

Themis, a company located in Vienna (Austria), previously developed an experimental vaccine against chikungunya fever in collaboration with Institut Pasteur in Paris, based on a measles vector technology and exclusively licensed to Themis.  Once the coronavirus diseases struck, Themis shifted some of its efforts to use the very same technology to design a COVID-19 vaccine. “Our vector is nothing else than the classic measles vaccine” said Erich Tauber the CEO of Themis. The measles antigens stay in place, but added to them is a cassette with antigens for SARS-CoV-2. The platform is taking advantage of the long known manufacturing and regulatory history of the measles vaccine. Themis with Institut Pasteur and the University of Pittsburgh (USA) answered a call from CEPI (Coalition for Epidemic Preparedness), a Norway based, public-private partnership set up to develop vaccines for future pandemics.  Phase 1 clinical trials are planned to begin in Paris with the Themis vaccine in the first days of summer. In August of 2019, Merck had already established a partnership with Themis while working on a undisclosed disease target and it had committed up to $200 million if successful milestones were met. The amount of money Merck will to pay for the acquisition was not disclosed, but Themis will remain focussed on pandemic preparedness and will keep its Vienna home base.

The partnering of Merck with IAVI – a non-profit research group dedicated to addressing urgent and unmet global health challenges – , will be established on a preclinical candidate, based on the same vesicula stomatitis virus (VSV) technology platform used by Merck to produce Ervebo, the world’s only approved Ebola vaccine. From early days the VSV platform has been seen as a highly valuable one that might be used as a backbone for multiple vaccines. The IAVI vaccine could also enter human clinical studies later this year. “The fact that regulatory authorities are familiar with this platform is a big asset for our program, as well for their review” said Mark Feinberg, the President and CEO of IAVI.

In both cases it is more than of passing interest to note that Merck has selected vaccines based on existing and robust technologies, where regulatory and manufacturing issues have already been well documented. The company history of developing vaccines is clearly a major asset in making the right choices, setting more reliable timelines and not promising a quick fix. “I think the clinical development side is going to take longer than people imagine” said Perlmutter. In a interview with the Financial Times, Ken Frazier Merck’s CEO said “The 12 to 18-month timeline often floated to COVID-19 vaccines is very aggressive and not something I would put out there that I would want to hold Merck to”. And later on: “You want to make sure that when you put a vaccine into millions, if not billions, of people it is safe”.

Merck and Ridgeback Biotherapeutics (Miami, Florida) have entered a collaboration to accelerate the development of EIDD-2801, a novel antiviral candidate, currently in preclinical development, for the treatment of COVID-19. Under the terms of the agreement Merck will gain worldwide access to EIDD-2801 and other related molecules and Ridgeback Bio will receive undisclosed upfront payment, specified milestones and a share of the net proceeds of EIDD-2801, if approved. Merck will be responsible for clinical development, regulatory filings and manufacturing.  EIDD-2801 is an orally-bioavailable form of a potent ribonucleoside analogue that inhibits the replication of multiple RNA viruses, including SARS-CoV-2. In preclinical settings EIDD-2801 has been shown to improve pulmonary function, decrease body-weight loss and reduce the amount of virus in the lung. The molecule was invented at Drug Innovations at Emory (DRIVE) a non-profit organisation wholly owned by Emory University in Atlanta.

Paris, May 27, 2020

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