GSK sets the stage for a toe-to-toe mar­ket show­down with Gilead­'s HIV cham­pi­on Tru­va­da

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 DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

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.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

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.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

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.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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