Merck & Co. on Tuesday announced a raft of initiatives designed to help tackle the COVID-19 pandemic, including the development of two vaccines against SARS-CoV-2 and the licensing of an oral antiviral candidate. CEO Kenneth Frazier remarked "we are proud to mark the culmination of our swift, conscientious and concerted effort to identify some of the most promising solutions to this global challenge and to put our resources to use in accelerating these efforts."
Under the first deal, Merck agreed to acquire Themis Bioscience for an undisclosed sum, gaining the latter's experimental COVID-19 vaccine candidate. The vaccine uses Themis' measles virus vector platform, which was originally developed at the Institut Pasteur and licensed to the company in 2010. Earlier this year, Themis joined a consortium together with the Institut Pasteur and the Center for Vaccine Research at the University of Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine for the prevention of COVID-19.
Merck noted that Themis' vaccine is currently in preclinical development with clinical studies planned to start later in 2020. Meanwhile, Merck noted that under a separate collaboration with IAVI, it also expects to advance a second preclinical vaccine against SARS-CoV-2 into clinical trials later this year. The vaccine uses the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck's Ebola Zaire virus vaccine, Ervebo (rVSVΔG-ZEBOV-GP), which was the first rVSV vaccine approved for use in humans and prequalified by the World Health Organization.
According to Merck, the vaccine has been designed and engineered by IAVI scientists, while the drugmaker will lead regulatory filings globally. Alongside the deal, Merck has also signed an agreement in the US with the Biomedical Advanced Research and Development Authority (BARDA) to provide initial funding support for the rVSV vaccine.
"Merck intends to make any vaccine or medicine we develop for this pandemic broadly accessible and affordable globally, and we are working now to accomplish this goal as quickly as possible," Frazier added. Merck indicated that it has entered into a memorandum of understanding with the Institut Pasteur and CEPI that reflects the parties' commitments, with pricing that makes the vaccine both available around the world and accessible to those who need it, including low-income, middle-income and high-income countries.
Further, Merck unveiled an agreement with Ridgeback Biotherapeutics to develop EIDD-2801, an orally available antiviral candidate currently in early clinical development for the treatment of patients with COVID-19. Under the deal, Merck will make an undisclosed upfront payment to Ridgeback to gain exclusive global rights to develop and commercialise EIDD-2801 and related molecules.
"Clinical evaluation of EIDD-2801 in COVID-19 patients is just beginning, now that Phase I studies have demonstrated that the compound is well-tolerated," remarked Roger Perlmutter, president of Merck Research Laboratories. Perlmutter added "since preclinical studies demonstrate that EIDD-2801 has potent antiviral properties against multiple coronavirus strains including SARS-CoV-2, we are eager to advance the next phase of clinical studies as rapidly and responsibly as possible."
According to Merck, 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 animal studies, EIDD-2801 has been shown to improve pulmonary function, decrease body-weight loss and reduce the amount of virus in the lung.
As part of the deal, Merck will make specified milestone payments to Ridgeback, with the latter also eligible to receive a share of the net proceeds of EIDD-2801 and related molecules. Under the agreement, Merck will be responsible for clinical development, regulatory filings and manufacturing.
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