It was bound to happen. As the COVID-19 pandemic spread around the globe, biopharma companies big and small geared up to test experimental drugs and vaccines or to potentially repurpose approved drugs to fight the disease. Many scaled up manufacturing capabilities for pharmaceutical ingredients, existing compounds, and launched clinical trials. Now they’re asking help paying for it and warn that if governments want these therapies to be rolled out quickly and fairly, it’s going to require significant coordination and upfront funding.
David Loew, executive vice president of Sanofi Pasteur, one of the top vaccine manufacturers in the world, indicated governments would need financial commitments in the billions to underwrite the acquisition of the most promising vaccines even before proof they were viable.
“If the industry does not know if there will be a market in 18 months, [it] cannot carry all [the costs],” he told the Financial Times. “Industry alone can’t provide all the investment needed now for billions of doses.”
At least some of the concern is that without greater funding and coordination, the companies won’t be able to buy sufficient raw materials, continue production of existing drugs, and quickly scale up their capacity to meet the demand of new drugs and older therapies around the world.
The Financial Times notes, “Particular concern over poorer countries’ access to medical supplies was highlighted by G20 health ministers’ failure at the weekend to issue a declaration of solidarity after this was blocked by the U.S.”
“This is a global issue,” said Seth Berkley, head of Gavi, a multilaterally-backed vaccines fund. “We need an agreement on global access and manufacturing at risk [of uncertainty over the results] to purchase very large quantities at low prices for distribution in low-income countries.”
On April 4, Gilead Sciences, which is currently testing its antiviral drug remdesivir against COVID-19, announced it was scaling up its production of the experimental drug. It had 1.5 million individual doses, enough to treat 140,000 patients. The expanded manufacturing goal is for enough doses to treat more than 500,000 patients by October and to have enough supply by the end of 2020 for another 500,000 patients.
The company indicated at the time that it did not intend to charge for this. The company also indicated remdesivir, which is currently one of the drugs showing the most promise of being effective against the disease, is not easy to manufacture. Gilead stated, “It is a linear process that requires specialized chemistry and multiple chemical reactions, some of which can take several weeks to complete. It also calls for scarce raw materials as well as sterile manufacturing capabilities with limited global capacity, which are needed to make finished vials ready for administration to patients.”
Certain nonprofits are stepping up to raise money, although governments are likely going to have to come forward with more funding. The Coalition for Epidemic Preparedness Innovations has raised $765 million so far towards its goal of $2 billion for vaccine research and development. Much less has been targeted for manufacturing.
Loew recommends an international group of scientists should provide consultation on where products are most needed based on the spread of the disease. “There needs to be worldwide solidarity,” he told the Financial Times. “If there isn’t, [the pandemic] will affect certain regions harder than others and lead to migration.”
Biopharma companies have also expressed concern that the coronavirus outbreak will follow the pattern of earlier pandemics, notably Ebola and the 2009 flu pandemic. Not that they are concerned it will dwindle and fade, which would be a good thing for the world in general, but that after they ended, biopharma companies that had geared up to develop vaccines and therapeutics were left holding the bag with little or no support to continue developing the drugs and vaccines.
“The investment required is too large for any company,” said Christophe Weber, chief executive officer of Takeda. “Society will have to finance this huge investment. My fear is the same as after the flu pandemic, when everybody loses interest.”
David Ricks, chief executive officer of Eli Lilly and currently president of the International Federation of Pharmaceutical Manufacturers and Associations, also called for government support. “People should not be taking advantage,” he said. “I agree 100%. That would be an unethical position in this time of need. But investors give us capital and expect a return.”
He praised U.S. and European regulators for their help so far but called for more flexibility in streamlining drug approvals as well as “mutual recognition between agencies of each other’s decisions.”