HIV pa­tients will have to wait a while longer for a long-act­ing vi­ral sup­pres­sion reg­i­men as the FDA has re­ject­ed Vi­iV Health­care’s NDA for the month­ly in­jec­tion of cabote­gravir and rilpivirine.

Reg­u­la­tors hand­ed the GSK sub­sidiary a com­plete re­sponse let­ter days be­fore the orig­i­nal PDU­FA date on De­cem­ber 29. While Vi­iV had been ex­pect­ing a smooth sail to the fin­ish line based on glow­ing clin­i­cal re­sults, the CRL cit­ed con­cerns with chem­istry man­u­fac­tur­ing and con­trols.

“There have been no re­port­ed safe­ty is­sues re­lat­ed to CMC and there is no change to the safe­ty pro­file of the prod­ucts used in clin­i­cal tri­als to date,” Vi­iV added in a short state­ment.

Kim Smith

A de­lay here with the month­ly in­jec­tion of cabote­gravir and rilpivirine al­so means that Vi­iV will have to push back on the planned sN­DA fil­ing for the 2-month­ly reg­i­men, which was slat­ed for the first quar­ter of 2020.

Gilead’s block­buster cock­tails, both dou­blets and triplets, have been im­mense­ly suc­cess­ful at keep­ing HIV to un­de­tectable lev­els, but they have still left pa­tients sad­dled with the bur­den of tak­ing dai­ly pills — which Vi­iV said is not on­ly in­con­ve­nient but al­so car­ries an emo­tion­al bur­den. With their new for­mu­la­tion of their own ex­per­i­men­tal cabote­gravir (in­te­grase in­hibitor) and J&J’s rilpivirine (non-nu­cle­o­side re­verse tran­scrip­tase in­hibitor), Vi­iV was look­ing to shake up the treat­ment land­scape and carve out a big­ger share from the Gilead-dom­i­nat­ed mar­ket.

The long-act­ing reg­i­men is de­signed for pa­tients who are al­ready vi­ro­log­i­cal­ly sup­pressed, have nev­er ex­pe­ri­enced vi­ro­log­i­cal fail­ures, and have not de­vel­oped re­sis­tance to ei­ther of the in­gre­di­ents. Vi­iV head of R&D Kim Smith has es­ti­mat­ed that around 10% to 15% of all pa­tients in the clin­ic would be can­di­dates.

Two late-stage stud­ies in­volv­ing 1180 pa­tients sug­gest­ed that their in­jec­tion was just as ef­fec­tive as stan­dard an­ti­retro­vi­ral ther­a­py in vi­ro­log­ic sup­pres­sion, with sim­i­lar rates of re­sis­tance at 1%. And as they fol­low up on a Phase IIb tri­al, re­searchers found that 83% of pa­tients re­main vi­ral­ly sup­pressed at the three-year mark.

That, along­side sim­i­lar­ly pos­i­tive da­ta for the 2-month­ly reg­i­men, would have made a ground­break­ing treat­ment op­tion. The com­pa­ny said it’s work­ing close­ly with the FDA to fig­ure out the next steps.

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.