Chip­ping away at Gilead­'s HIV em­pire, GSK's Vi­iV sub­mits NDA for 2-drug HIV reg­i­men -- play­ing vouch­er card for speedy FDA re­view

GSK’s am­bi­tion to cap­ture a big­ger piece of the HIV drug mar­ket from US ri­val Gilead con­tin­ues as its ma­jor­i­ty-owned Vi­iV Health­care sub­mit­ted an ap­pli­ca­tion to mar­ket it’s two-drug  treat­ment com­pris­ing do­lute­gravir (DTG) and lamivu­dine (3TC) to the FDA in tan­dem with a pri­or­i­ty re­view vouch­er (PRV), em­pow­er­ing the com­pa­ny to re­ceive a re­sponse from the US reg­u­la­tor in a faster-than-stan­dard six months.

Vi­iV was es­tab­lished in 2009 by the British drug­mak­er in part­ner­ship with Pfiz­er $PFE, with Sh­iono­gi join­ing as a share­hold­er in 2012. The com­pa­ny’s cur­rent port­fo­lio of 13 an­ti­retro­vi­ral HIV ther­a­pies gen­er­at­ed £4.35 bil­lion last year. On Fri­day a spokesper­son from the Mid­dle­sex, UK-based com­pa­ny said it had pro­cured the PRV from GSK which was grant­ed the trop­i­cal dis­ease PRV af­ter se­cur­ing ap­proval for its malar­ia drug Krintafel ear­li­er this year.

GSK’s {GSK} ap­proach to grab­bing mar­ket share from Gilead $GILD  — which cur­rent­ly dom­i­nates the HIV mar­ket that is es­ti­mat­ed to hit $22.5 bil­lion by 2025 — is to con­vince reg­u­la­tors, doc­tors and pa­tients to adopt its two-drug reg­i­mens, ver­sus Gilead’s triple-drug cock­tails, that could po­ten­tial­ly re­sult in few­er tox­ic side-ef­fects, re­duce dos­ing fre­quen­cy, and be more cost-ef­fec­tive. Some physi­cians — and Gilead — take the view that this may not be the most ef­fec­tive strat­e­gy be­cause the virus will on­ly have to fight against two drugs which could cul­mi­nate in drug re­sis­tance.

Re­sults of two phase III GEM­I­NI tri­als test­ing the two-drug reg­i­men of DTG and 3TC pre­sent­ed ear­li­er this year showed that Vi­iV’s ther­a­py worked as well as stan­dard three-drug ther­a­py in treat­ment-naive pa­tients with both low and high lev­els of the virus, and sig­nif­i­cant­ly, no pa­tient in the 1,400 pa­tients en­rolled across the tri­als, de­vel­oped drug re­sis­tance. This was a cru­cial wor­ry as there was a re­port­ed case of drug re­sis­tance in a pre­vi­ous study.

If ap­proved, this DTG and 3TC reg­i­men is al­so poised to be cheap­er as 3TC is no longer patent pro­tect­ed. Mean­while, the DTG por­tion of the reg­i­men is un­der reg­u­la­to­ry in­ves­ti­ga­tion af­ter da­ta from pa­tients in Botswana sug­gest­ed a link be­tween the drug and birth de­fects.

Vi­iV, whose oth­er two-drug reg­i­men Ju­lu­ca that in­cludes DTG won FDA ap­proval last year, has al­ready sub­mit­ted an ap­pli­ca­tion to the sin­gle-tablet DTG and 3TG reg­i­men with Eu­ro­pean reg­u­la­tors in Sep­tem­ber.

Im­age: HIV Shut­ter­stock

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Eric Shaff (Seres)

Af­ter a 4-year so­journ, a strug­gling mi­cro­bio­me pi­o­neer claims a break­out PhI­II come­back. And they're tak­ing it straight to the FDA

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Ko­dak's $765M deal is on hold un­til al­le­ga­tions are cleared — US gov­ern­ment

Just two weeks after Trump administration officials toured Kodak’s Eastman Business Park, signed a letter of interest for a $765 million loan designed to spur domestic pharmaceutical manufacturing on a socially distanced stage and posed for photos with the company CEO, they’re putting the deal on hold.

The US International Development Finance Corporation announced the halt in a brief tweet just before market closed, tanking the stock 7.64% within minutes. Kodak shares plunged 42.81% to $8.51 Monday in pre-market trading — still multitudes higher than where it was for years prior.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.

No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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