As Merck and regulators around the world race to get molnupiravir approved for the treatment of COVID-19 - a U.S. Food and Drug Administration expert panel will deliberate its fate on November 30 – it may be important to look at just how this potential “miracle drug” came to be.
Emory University has a program called DRIVE LLC, which stands for Drug Innovation Ventures at Emory. It operates as a not-for-profit biotech company and is dedicated to developing drugs and vaccines that have limited applications. In March 2020, DRIVE partnered with Ridgeback Biotherapeutics to further develop a promising oral COVID-19 treatment (then known as EIDD-2801). Two months later, Merck joined the development party when it entered into a collaborative agreement with Ridgeback to develop the drug that would later become known as molnupiravir.
The journey, Joe Allen, executive director of the Bayh-Dole Coalition, said, “really shows how our system works.”
Between 2013 and 2020, the Emory Institute for Drug Development (EIDD) was awarded an estimated $35 million in grants by the U.S. government. Importantly, this placed EIDD-2801 under the purview of the Bayh-Dole Act of 1980. The purpose of this act is to encourage the private-sector investment necessary to turn basic government-funded research into tested and approved products. It empowers universities, small businesses and non-profit institutions to take ownership of inventions made during federally-funded research, so they can license them for further applied research and development and broader public use.
In November 2019, Emory realized this experimental drug could have significant potential in respiratory viruses such as COVID-19. So they took EIDD-2801 to the Biomedical Advanced Research and Development Authority (BARDA) and made their case for the drug. According to Allen, they were turned down twice.
The Bayh-Dole Act states that when hoping to commercialize drugs borne of government-funded research, the academic institution must give preference to a small company.
Allen said this is because “small companies traditionally are willing to take risks that large companies won’t take.” So, when Emory was approached by Ridgeback, it seemed like a perfect union. Particularly because Ridgeback has experience in fighting pandemics. In December 2020, the FDA approved Ridgeback’s Ebanga™ for the treatment of Ebola.
True enough, Ridgeback did not give up on the drug. Under the leadership of CEO Wendy Holman, the company struck out on its own and began to conduct preliminary clinical trials. Holman was in the middle of applying for government funding when she appeared on a Bayh-Dole Coalition webinar Allen was hosting.
“I can see how frustrated she is, because she's like, this could really be breakthrough she can’t get anybody to listen to her,” Allen said, adding that BARDA turned Ridgeback down as well. But they persevered and found Merck.
“To its credit, after Merck got involved, the government did come back and partner with them and they did help on some of the later stage trials,” Allen noted. “And the Biden administration has already negotiated with Merck to go ahead and say, if this is cleared by FDA, we’ll start purchasing it, which is what they did for the vaccines.”
On June 9, the U.S. government committed to procuring approximately 1.7 million courses of molnupiravir pending emergency use authorization (EUA). At this point, Allen said, “the company knows it is full steam ahead because [they’ve] actually got people who are going to use it.”
The real heroes, though, Allen said, are Emory and Ridgeback.
“The most important thing in commercialization is passion, and if you hadn't had the passion at Emory and hadn't had the passion at Ridgeback, this thing would never have even been developed. They persisted when the whole system was basically telling them they were wrong, turning them down even in the midst of a crisis,” Allen said.
Credit must also be given to Merck – whether from a social good or business savvy standpoint is irrelevant – because this isn’t the first time in recent history it has been at the end of the R&D pipeline for a drug to treat a pandemic. In 2019, the FDA approved its first vaccine for Ebola, Merck’s rVSV-ZEBOV (Ervebo).
This breakthrough came at the end of a winding 20-year odyssey that began at Canada’s National Microbiology Laboratory in Winnipeg, Manitoba. Ervebo was then licensed by Iowa State University start-up BioProtection Systems Inc. (BPS), now Lumos Pharma, and underwent early manufacturing at IDT Biologika GmbH in Germany
When the West African Ebola crisis struck in 2014, Merck came in to finish the development job.
