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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Silviu Itescu, Mesoblast CEO

Mesoblast sends in im­proved po­ten­cy as­say, look­ing to re­sub­mit to FDA on acute graft-ver­sus-host dis­ease drug

In 2020, the FDA rejected Mesoblast’s remestemcel-L, or Ryoncil, its lead candidate for pediatric acute graft-versus-host disease (aGVHD) that didn’t respond to steroids. The FDA raised a number of concerns, first objecting to Mesoblast’s single arm, open-label trial, though regulators struggled to describe how a randomized trial would work, since pediatricians and parents were reluctant to put children with aGVHD in a placebo arm.

Johnny Stilou, Scandion Oncology acting CEO

Scan­dion's shares fall af­ter on­col­o­gy biotech re­ports PhII fail

Danish biotech Scandion Oncology posted some Phase II results on Friday, and investors were none too pleased.

The biotech reported topline results from the second part of an ongoing Phase II trial called CORIST. The study was investigating Scandion’s lead candidate SCO-101 in 25 patients as a combination treatment with FOLFIRI chemotherapy in metastatic colorectal cancer. And so far, the study did not meet the biotech’s primary endpoint: tumor reduction of at least 30%.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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