Covid-19 roundup: Gilead touts pre­clin­i­cal promise for oral remde­sivir; Roche pre­pares for virus to be­come en­dem­ic

With remde­sivir still stand­ing as the on­ly an­tivi­ral ap­proved to treat Covid-19, Gilead has been ex­plor­ing new ways to ex­pand its use. Now its re­searchers, in col­lab­o­ra­tion with a team from the Uni­ver­si­ty of Car­oli­na in Chapel Hill, have come up with pre­clin­i­cal re­sults back­ing up an oral can­di­date.

And they have their sights set be­yond Covid-19.

GS-621763, a pro­drug of the parental nu­cle­o­side of remde­sivir, ap­peared promis­ing in both in vit­ro ex­per­i­ments in cell cul­tures and in vi­vo ex­per­i­ments in­volv­ing mice. No­tably, the sci­en­tists al­so com­pared GS-621763 against Mer­ck’s mol­nupi­ravir, an­oth­er oral nu­cle­o­side ana­log an­tivi­ral cur­rent­ly be­ing test­ed in hu­mans, and found both drugs to be “sim­i­lar­ly ef­fi­ca­cious.”

They start­ed the pa­per, post­ed on bioRx­iv, by not­ing that lag­ging vac­ci­na­tion rates, cou­pled with wan­ing im­mu­ni­ty and break­through in­fec­tions by SARS-CoV-2 vari­ants, high­light the need for sec­ond-gen­er­a­tion treat­ments — but ther­a­peu­tic op­tions are lim­it­ed. The ones that are avail­able, such as remde­sivir and the mon­o­clon­al an­ti­bod­ies, large­ly have to be in­fused in­tra­venous­ly, hin­der­ing wide­spread use, not to men­tion that some an­ti­bod­ies are show­ing signs of di­min­ished ef­fi­ca­cy against vari­ants.

By tar­get­ing a high­ly con­served RNA-de­pen­dent RNA poly­merase, GS-621763 is tout­ed as an al­ter­na­tive can­di­date that can fight through all those mu­ta­tions. Across stud­ies, it showed “sig­nif­i­cant an­tivi­ral ac­tiv­i­ty in lung cell lines and two dif­fer­ent hu­man pri­ma­ry lung cell cul­ture sys­tems” and trig­gered “dose-de­pen­dent an­tivi­ral ac­tiv­i­ty in mice in­fect­ed with SARS-CoV-2” with re­gards to vi­ral load, lung pathol­o­gy and pul­monary func­tion, they re­port­ed in a preprint.

Gilead has al­so pro­posed the op­tion of in­tranasal de­liv­ery, with tri­als for an in­haled for­mu­la­tion of remde­sivir un­der­way.

“Next-gen­er­a­tion oral coro­n­avirus (CoV) an­tivi­rals, if wide­ly dis­sem­i­nat­ed and giv­en ear­ly in in­fec­tion, could cur­tail the du­ra­tion of dis­ease, re­duce long-term se­que­lae of COVID-19, min­i­mize house­hold trans­mis­sions, and lessen hos­pi­tal­iza­tions, thus hav­ing a broad im­pact on pub­lic health,” they wrote.

The goal, though, is not just to fight Covid-19, but any oth­er coro­n­avirus that emerges in the years to come.

The da­ta pro­vid­ed here­in sup­ports the fu­ture eval­u­a­tion of oral­ly bioavail­able pro­drugs of GS-441524 in hu­mans with COVID-19. If safe and ef­fec­tive, this class of RdRp in­hibitors could be­come part of the ar­se­nal of ex­ist­ing oral an­tivi­rals that are des­per­ate­ly need­ed to ad­dress a glob­al un­met need for the COVID-19 pan­dem­ic and CoV pan­demics of the fu­ture.

Pre­dict­ing 200M-500M cas­es each year, Roche vows to keep up Covid-19 R&D

Roche doesn’t see Covid-19 go­ing away any time soon, if ever.

That’s why the phar­ma gi­ant will keep work­ing on treat­ments and di­ag­nos­tics against the coro­n­avirus, said Bar­ry Clinch, glob­al head of in­fec­tious dis­ease clin­i­cal de­vel­op­ment, on a con­fer­ence call with an­a­lysts, per Bloomberg.

On top of mak­ing Covid-19 di­ag­nos­tics and help­ing Re­gen­eron man­u­fac­ture its an­ti­body cock­tail, Roche is al­so de­vel­op­ing an an­tivi­ral to tack­le the in­fec­tion.

The way Roche sees it, the dis­ease will most like­ly be­come sea­son­al and en­dem­ic, with 200 mil­lion to 500 mil­lion new in­fec­tions each year — not just an­oth­er com­mon cold.

While the virus will “be­come eas­i­er to man­age over time,” it will still call for man­age­ment, Clinch was quot­ed as say­ing, rep­re­sent­ing a mid­dle ground be­tween the best-case sce­nario of it dis­ap­pear­ing and a worst-case sce­nario of it be­com­ing un­pre­dictable due to con­stant mu­ta­tions.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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