SWITZERLAND – GlaxoSmithKline’s ViiV Healthcare has committed to grant voluntary license on the patents for its injectable HIV prevention drug to make it more widely available in poorer nations, where fewer than a third of those at risk are on prophylactic treatment.

Deborah Waterhouse, ViiV chief executive, said in an interview that the GSK majority-owned drugmaker was committed to licensing the patents relating to the drug and that it was in talks over terms with the UN-backed Medicines Patent Pool.

ViiV makes cabotegravir, a long-acting, injectable drug that is highly effective in preventing HIV infection.

It is given as infrequently as six times per year. A license would enable generic makers to produce more of the drug at affordable prices without the risk of patent litigation, widening availability at the same time.

The move underscores how protracted battles on intellectual property during the Covid-19 pandemic, especially for vaccines, may have altered how companies think about access to medicines.

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

Cabotegravir competitors in the market

In the US, the medication 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 medicine was approved in Europe and eight months after its US FDA nod.

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.

Significant challenges still remain

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

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 ensure 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.

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