With solid results in hand, Gilead inks manufacturing deal for HIV med
- Gilead Sciences Inc.'s fixed-dose combination of bictegravir with a dual-NRTI backbone of emtricitabine/tenofovir alafenamide (FTC/TAF) was non-inferior to regimens containing a boosted protease inhibitor (bPI) in HIV-1 infected patients, according to Phase 3 results the company announced at IDWeek in San Deigo.
- The big biotech also announced on Wednesday that it has inked an agreement with the United Nations-backed Medicines Patent Pool (MPP) to provide better access to bictegravir once it’s approved in the U.S.
- Gilead’s one-dose triple combo regimen was filed with the Food and Drug Administration on June 12 with a priority review voucher. The agency set a user fee goal date of Feb. 12, 2018.
The late-stage investigation, dubbed Study 1878, showed that not only was the integrase strand transfer inhibitor non-inferior in the virologically-suppressed patients, but also showed no evidence of treatment resistance in patients at 48 weeks.
"These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs," said Eric Daar, lead author of the study and chief of the HIV medicine division at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, in an Oct. 4 statement.
Gilead believes that the regimen could offer a more convenient dosing schedule and pill load for a variety of HIV patients, while also maintaining the efficacy and safety of currently available therapies.
Further demonstrating Gilead’s faith in the efficacy and success of bictegravir is the licensing agreement it established with the MPP. The deal allows generic drug manufacturers in China, South Africa and India to manufacture the drug, either alone or in combination with other HIV therapies, for 116 low-income countries.
The manufacturing agreement will make bictegravir the fifth Gilead HIV medication that is provided through generic distributors for HIV patients in the developing world. Currently, 90% of Gilead HIV medicines taken by patients in the developing world are generics. Due to the high volume of competition amongst these copycat drugmakers, the price of Gilead medications has decreased by 80% since 2006 to about $3.50 per patient in the developing world.
"Today, more than 10 million people in resource-limited countries are on Gilead-based HIV therapies, which would not be possible without these strong alliances," Gregg Alton, EVP for corporate and medical affairs at Gilead, said in the statement.
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