The funds will help spur generic-drug manufacturers, some of which have indicated they could produce as many as 10 million treatments a month, according to Trevor Mundel, president of the global-health division at the Gates foundation. While regulatory hurdles and other challenges need to be resolved, those drugmakers could start shipments in the first quarter, he said.
"Could there be twists in that plot, and could there be delays, yes, but that's what we've got to aim for," Mundel said in an interview. "There's a lot of capacity out there, but it's a question of when they actually commit to that."
The drug's progress has been accompanied by concerns that lower-income nations struggling to obtain vaccines could be left behind once again when it comes to therapies. The foundation is calling on other donors to devote resources to accelerating the rollout of Merck's experimental molnupiravir to poorer nations if it's approved.
The production potential won't be realized without incentives and guarantees in place, Mundel said. Manufacturers are uncertain of the level of demand for the therapy, who will pay for it and how much production to allocate, he said, "so we want to get them off the sidelines and actually into action."
Merck itself expects to produce 10 million courses by the end of the year, and substantially more should become available in 2022.
The drugmaker has taken steps to ensure countries around the world can get its medicine, including licensing the medication to generic-drug firms. Merck and partner Ridgeback Biotherapeutics LP last week sought U.S. emergency use authorization, and the treatment is set for U.S. Food and Drug Administration committee review next month.
Still, health advocates are calling for further action to broaden availability of Covid drugs, including increased testing in lower-income nations to detect cases in the first days of infection, when the drugs could be most effective.
Some wealthy and middle-income nations like Australia, Singapore, Malaysia and Thailand have already followed the U.S. and secured the drug or started talks to obtain it. Meanwhile, a global initiative to deploy treatments is at risk of running into the same problems the Covax vaccine distribution effort has faced, according to an independent report commissioned by the World Health Organization.
The Gates organization aims to significantly reduce the time it takes for new drugs to arrive in low-income regions after they become available in wealthier markets. That gap, it said, can be at least 12 months. Some of the latest funding includes $2.4 million in grants to help speed generic companies' applications to the WHO for manufacturing pre-qualification.
The foundation highlighted its move in 2017 to establish a volume guarantee with two generic suppliers to bring HIV therapies to lower-income countries. That work was carried out in coordination with the U.S. President's Emergency Plan for AIDS Relief, or PEPFAR, and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
Published : October 21, 2021
By : Bloomberg