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GSK’s ViiV to work with Medicines Patent Pool, generic manufacturers to bolster access to long-acting HIV prevention med Apretude

Hot on the heels of Pfizer’s access accord, GSK’s ViiV Healthcare is teaming up with its old friend the Medicines Patent Pool (MPP) to broaden access to its latest HIV prevention med.

Specifically, ViiV has pledged to license its patents on long-acting cabotegravir for HIV pre-exposure prophylaxis (PrEP), and it’s starting to hash out voluntary licensing terms with MPP, the company said Friday. The parties are working to bring a voluntary license to fruition “as quickly as possible to help enable at scale access to cabotegravir LA for PrEP in low- and middle-income countries,” ViiV said in a release.

Cabotegravir, branded Apretude in PrEP, won its prevention nod back in December, scoring an FDA green light to reduce the risk of sexually acquired HIV. The move provided users with the first long-acting injectable in the PrEP setting.

Stateside, the med will challenge Gilead Sciences’ entrenched Truvada and its generics, plus the biotech’s newer Descovy. Those medications come in the form of daily pills, whereas Apretude is administered once every two months after the loading doses.

ViiV and MPP are longtime allies. Together, the groups have helped tee up the manufacture and sale of cheaper versions of ViiV drugs in countries hard hit by HIV, which are also “least able to pay for treatment and care,” ViiV said.

A similar deal made generics of another ViiV drug, dolutegravir, available for at least 20 million people living with HIV in low- and middle-income countries as of December 2021, the company added.

MPP and ViiV forged their dolutegravir pact back in 2014, just two months after the med’s European approval and eight months after its U.S. FDA green light. Historically, it’s taken an average of seven to nine years for generic versions of new HIV treatments to reach developing countries after their debut in industrialized nations, ViiV and MPP said at the time.

As for cabotegravir, approved in December, ViiV is “excited by the potential role that this long-acting injectable medicine for HIV prevention can play in helping to avert the transmission of HIV and ending the HIV epidemic by 2030,” Deborah Waterhouse, the company’s CEO, said in a statement.

A voluntary license marks an essential step in the parties’ access plan, but “significant complexities and considerations” remain, ViiV and MPP said in their release.

For one, long-acting injectables like cabotegravir are trickier to manufacture than oral anti-retroviral medicines, ViiV pointed out. Further, there may be capital investment needs. And compared to retrovirals, long-acting injectables boast “evolving and less well-defined demand.”

To make sure its license breeds success, ViiV says it will also work with funders, procurement agencies, community groups and generic manufacturers “to help find workable and sustainable solutions to enable generic manufacturing as quickly as possible.”

Until a cabotegravir generic is on tap, ViiV has pledged to supply its long-acting injectable at a nonprofit price for public programs in low-income, least developed and all sub-Saharan African countries.

ViiV’s latest MPP deal comes shortly after Pfizer, riding high on its COVID vaccine and therapeutics sales, said it would make 23 of its medicines, many of which are patented, available to 45 low-income countries. Pfizer will offer the meds at a not-for-profit price.

Meanwhile, Pfizer and Merck last year lined up agreements with MPP to facilitate affordable global access to their COVID antivirals.Separately, AstraZeneca, BeiGene, Bristol Myers Squibb, Gilead Sciences, Novartis, Roche, Sanofi and Teva recently enlisted with the Access to Oncology Medicines coalition, which aims to help improve access to cancer meds on the World Health Organization’s essential medicines list—or those likely to be included in the future—in low- and middle-income countries.