(Bloomberg) -- The Bill & Melinda Gates Foundation said millions of courses of Merck & Co.’s promising pill for Covid-19 could begin to reach lower-income nations early next year as the charity kicks in as much as $120 million to widen global access to the therapy. 

The funds will assist generic-drug manufacturers, some of which have indicated they could produce as many as 10 million treatments a month, Trevor Mundel, president of the global health division at the Gates Foundation, said in an interview. While regulatory hurdles and others challenges need to be resolved, those drugmakers could start making 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,” he said. “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 Covid 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.

Off Sidelines

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 has said it 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 drug, including licensing the medication to generic-drug firms. Merck and partner Ridgeback Biotherapeutics LP last week sought U.S. emergency use authorization for it, and it’s set for U.S. Food and Drug Administration committee review next month. 

Some wealthy and middle-income nations like Australia, Singapore, Malaysia and Thailand have already followed the U.S. and secured the treatment or started talks to obtain it. Meanwhile, a global initiative to deploy Covid 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 said it 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. 

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.

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