Vi­iV Health­care and ma­jor­i­ty own­er Glax­o­SmithK­line have cleared an­oth­er im­por­tant hur­dle on a long-run­ning quest to chal­lenge Gilead’s dom­i­nance in pre­ven­ta­tive HIV treat­ments.

The fi­nal analy­sis of a new study shows the GSK sub­sidiary’s long-last­ing in­jec­tion, cabote­gravir, proved 66% more ef­fec­tive in HIV pre­ven­tion than Gilead’s break­through Tru­va­da pill. And they now in­tend to carve away some of the block­buster rev­enue that Gilead has en­joyed for years.

The study, re­leased Tues­day, com­pared the ef­fects of pa­tients tak­ing cabote­gravir ver­sus those tak­ing dai­ly oral pills. With­in the in­jec­tion arm of the test, re­searchers doc­u­ment­ed on­ly 13 cas­es of HIV, or an in­ci­dence rate of 0.41%. In the pill arm, 39 cas­es were found, amount­ing to a rate of 1.22%. The study al­so not­ed high lev­els of ad­her­ence to dai­ly oral ther­a­py.

Due to the Covid-19 pan­dem­ic, the blind­ed phase of the study was halt­ed in May. Af­ter a fi­nal analy­sis and re­view, Vi­iV was able to con­firm the in­jec­tions proved more ef­fec­tive than dai­ly pills at the high­light­ed 66 per­cent rate.

Kim­ber­ly Smith

“This ad­vance­ment has the po­ten­tial to be a game-chang­er for HIV pre­ven­tion, of­fer­ing … the con­ve­nience of re­duced dos­ing from dai­ly to just six times per year,” Kim­ber­ly Smith, R&D chief at Vi­iV, told Reuters.

The re­sults of the study come as gener­ic ver­sions of Tru­va­da, a once-dai­ly pill that re­duces the risk of con­tract­ing HIV through sex by about 99 per­cent, are about to hit the mar­ket. Tru­va­da and De­scovy, an­oth­er Gilead HIV treat­ment, have al­lowed the com­pa­ny to es­sen­tial­ly own the en­tire drug sec­tor ever since Tru­va­da was green-lit by the FDA in 2012 as the first pre­ven­ta­tive mea­sure for HIV.

How­ev­er, Gilead is fac­ing a law­suit from ac­tivists claim­ing the com­pa­ny ex­tend­ed its mo­nop­oly by il­le­gal­ly al­ter­ing de­vel­op­ment times, and a law­suit from the US gov­ern­ment al­leg­ing im­prop­er patent prac­tices. Gilead has al­so faced heavy crit­i­cism of price goug­ing, as Tru­va­da treat­ment can cost around $20,000 per year.

Tru­va­da net­ted Gilead $2.8 bil­lion in sales last year in both HIV pre­ven­tion and treat­ment.

Though Tru­va­da and De­scovy are al­ready high­ly ef­fec­tive treat­ments, GSK hopes it can sell the idea of in­creased com­pli­ance with its new drug. Be­cause cabote­gravir on­ly re­quires one in­jec­tion every two months, pa­tients are less like­ly to for­get to take it, as op­posed to the risk of miss­ing a dai­ly Tru­va­da pill.

Cabote­gravir has had its own share of road bumps as well. Back in De­cem­ber, the FDA is­sued a com­plete re­sponse let­ter to Vi­iV and re­ject­ed its ap­pli­ca­tion for month­ly cabote­gravir in­jec­tions, cit­ing man­u­fac­tur­ing and con­trol con­cerns. As a re­sult, the NDA for the bi­month­ly reg­i­men was pushed back from the first quar­ter of 2020.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.