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In a surprise move, ViiV Healthcare has decided not to license its long-acting injectable HIV prevention shot so that generic companies could make and distribute less expensive versions to low- and middle-income countries.

The company, which is largely controlled by GlaxoSmithKline (GSK), issued a statement saying that, after conducting a “rigorous assessment” with different generic companies and contract manufacturers, it would not be able to proceed with licensing due to manufacturing challenges, regulatory and capital requirements, infrastructure issues, and unpredictable demand.


As a result, ViiV will be the “sole supplier” for the Apretude shot on a global basis, “at least during the initial [launch] years.” There was no specific time frame mentioned, but the company did say it would work with the Medicines Patent Pool, a public health organization backed by the United Nations that arranges voluntary licensing with drugmakers.

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