Vi­iV, GSK gam­ble a sur­prise $130M chip in a high-stakes HIV play­off with Gilead

Glax­o­SmithK­line $GSK hasn’t had much to boast about over the last cou­ple of years when it comes to new drug de­vel­op­ment. But Vi­iV — the HIV spe­cial­ist which it con­trols a ma­jor­i­ty stake in — has proven to be a no­table ex­cep­tion to that rule.

To­day, Vi­iV con­tin­ued to live up to its star billing in­side GSK cir­cles, not­ing that it filed twin ap­pli­ca­tions at the FDA and the EMA for a com­bi­na­tion of do­lute­gravir (Tivicay) and rilpivirine (J&J’s Edu­rant), which it plans to mar­ket as the world’s first two-drug main­te­nance ther­a­py for keep­ing a lid on the lethal virus.

In a sur­prise, Vi­iV says that GSK re­cent­ly ac­quired a pri­or­i­ty re­view vouch­er (PRV) for $130 mil­lion and will use it to shave four months off the FDA re­view process. That should give it a clear shot at beat­ing Gilead to the mar­ket lat­er this year.

A spokesper­son for GSK de­clined to com­ment when I asked who they bought the vouch­er from. I have a query in to Marathon, which bagged a PRV in its con­tro­ver­sial ap­proval for an old steroid called de­flaza­cort af­ter gain­ing an ap­proval specif­i­cal­ly for Duchenne mus­cu­lar dy­s­tro­phy, but have yet to hear back.

Be­ing first to mar­ket here can be a valu­able ad­van­tage. The HIV mar­ket is worth bil­lions of dol­lars, and new com­bi­na­tions like these of­fer pro­longed hope for pa­tients hold­ing the virus at bay for years, with a grow­ing risk for ad­verse events from the meds keep­ing them alive. For GSK, main­tain­ing a lead­ing role with Vi­iV is ab­solute­ly es­sen­tial to re­tain­ing its in­vestors loy­al­ty.

Gilead $GILD re­cent­ly de­clared that all four of its Phase III stud­ies test­ing a com­bi­na­tion ther­a­py that adds bicte­gravir to its back­bone HIV ther­a­pies proved non-in­fe­ri­or to do­lute­gravir and oth­er an­ti­retro­vi­ral ther­a­pies. But it didn’t prove su­pe­ri­or, a prospect which had rat­tled GSK in­vestors. GSK’s stock surged on Gilead’s read­out, with Vi­iV seen ward­ing off a ma­jor threat by Gilead, which has been a dom­i­nant ri­val for years.

Gilead re­cent­ly ac­quired its own PRV from Sarep­ta for $125 mil­lion and is wide­ly ex­pect­ed to use it in its race against GSK/Vi­iV. As Gilead’s block­buster hep C fran­chise has be­gun to fade, the big biotech is in­creas­ing­ly re­liant on its main­stay HIV work. And any added pres­sure by GSK is like­ly to in­crease an­a­lysts’ fo­cus on a ma­jor deal to get Gilead’s num­bers point­ed back north.

“Tra­di­tion­al­ly, we have used a reg­i­men of three or more drugs to main­tain HIV vi­ral sup­pres­sion, but to best serve peo­ple liv­ing with HIV we must al­ways ques­tion the sta­tus quo,” not­ed Vi­iV chief sci­en­tist John C. Pot­tage in a state­ment. “We be­lieved that do­lute­gravir would have the right pro­file to be a core agent in a two-drug reg­i­men. Da­ta from the SWORD stud­ies sup­port­ed our hy­poth­e­sis that a two-drug reg­i­men of do­lute­gravir and rilpivirine could main­tain vi­ral sup­pres­sion and these reg­u­la­to­ry sub­mis­sions mark what may be a step change in HIV treat­ment.  We are grate­ful to the study par­tic­i­pants and clin­i­cians who have con­tributed so much to mak­ing these sub­mis­sions pos­si­ble.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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