Covid-19 roundup: Paul Hud­son says US will have first dibs on Sanofi vac­cine; Gilead se­lects 5 gener­ic man­u­fac­tur­ing part­ners for remde­sivir

If Sanofi can suc­cess­ful­ly de­liv­er a Covid-19 vac­cine, the US will get first ac­cess to it, CEO Paul Hud­son told Bloomberg News.

That’s be­cause the US, through its bio­med­ical de­fense agency BAR­DA, has in­vest­ed in the tech­nol­o­gy, back­ing the com­pa­ny’s Pro­tein Sci­ences sub­sidiary with a $30 mil­lion grant for its re­com­bi­nant Covid-19 vac­cine ef­fort. Since its found­ing in 2005, BAR­DA has heav­i­ly fund­ed both Sanofi — a French com­pa­ny — and Pro­tein Sci­ences, which was an in­de­pen­dent biotech un­til 2017.

“The U.S. gov­ern­ment has the right to the largest pre-or­der be­cause it’s in­vest­ed in tak­ing the risk,” Hud­son told Bloomberg. The US ex­pects “that if we’ve helped you man­u­fac­ture the dos­es at risk, we ex­pect to get the dos­es first.”

Hud­son’s com­ments are the lat­est glimpse at a sim­mer­ing bat­tle over who will get a vac­cine once it’s ap­proved. That bat­tle has par­tic­u­lar­ly cen­tered on the US and the Trump ad­min­is­tra­tion, which has es­chewed in­ter­na­tion­al co­op­er­a­tion — in­clud­ing an $8 bil­lion fund raised ear­li­er this month — in fa­vor of an in­ter­nal and thus far vague­ly de­fined ef­fort to get Amer­i­cans in­oc­u­lat­ed first. BAR­DA is fund­ing some of the world’s lead­ing Covid-19 vac­cine ef­forts, back­ing not on­ly Sanofi, but al­so putting around $1 bil­lion be­hind J&J and Mod­er­na’s ef­forts.

The de­bate be­gan in earnest in March, when Reuters and a lead­ing Ger­man news­pa­per re­port­ed that the Trump ad­min­is­tra­tion tried to lure Ger­man mR­NA vac­cine com­pa­ny Cure­Vac to the Unit­ed States. Ger­man sci­en­tists and of­fi­cials re­spond­ed with dis­may and ac­ri­mo­ny, con­demn­ing ef­forts for any coun­try to se­cure ex­clu­sive ac­cess to a vac­cine. The EU sub­se­quent­ly gave Cure­Vac an $89 mil­lion grant, in part to ex­pand man­u­fac­tur­ing on the con­ti­nent.

Since then, oth­er coun­tries have tried to se­cure ear­ly ac­cess. As­traZeneca said the UK will re­ceive first ac­cess to the Ox­ford vac­cine they have agreed to man­u­fac­ture.

Hud­son’s com­ments are par­tic­u­lar­ly sur­pris­ing be­cause Sanofi is a French com­pa­ny, and it’s un­clear how French of­fi­cials will re­spond. Hud­son said he has tried to en­cour­age Eu­rope to back vac­cine ef­forts in the way the US and Chi­nese gov­ern­ments have, but to lit­tle avail.

“I’ve been cam­paign­ing in Eu­rope to say the U.S. will get vac­cines first,” Hud­son said.  “That’s how it will be be­cause they’ve in­vest­ed to try and pro­tect their pop­u­la­tion, to restart their econ­o­my.”

Part­ner­ing with GSK, Sanofi has said they can pro­duce 600 mil­lion dos­es of their ex­per­i­men­tal vac­cine per year but are aim­ing for more. — Ja­son Mast

Gilead se­lects 5 gener­ic man­u­fac­tur­ers for remde­sivir

Gilead has sealed deals with five gener­ic man­u­fac­tur­ers in In­dia and Pak­istan to pro­duce remde­sivir for 127 coun­tries — most­ly low- and low­er-mid­dle in­come coun­tries but al­so a hand­ful of up­per mid­dle and high-in­come coun­tries where health­care ac­cess is an is­sue.

Soon af­ter the US-based com­pa­ny un­veiled piv­otal da­ta sug­gest­ing its an­tivi­ral could help hos­pi­tal­ized Covid-19 pa­tients re­cov­er faster, which prompt­ed the FDA to is­sue an emer­gency use au­tho­riza­tion, ex­ecs had laid out plans to ramp up mass pro­duc­tion around the world through vol­un­tary li­cens­es com­plete with tech trans­fers.

The five part­ners ini­tial­ly cho­sen are Cipla, Fer­oz­sons Lab­o­ra­to­ries, Het­ero Labs, Ju­bi­lant Life­sciences and My­lan. They are free to set their own prices for the drugs in the coun­tries where the li­cens­es are ef­fec­tive.

In a state­ment, Gilead added:

The li­cens­es are roy­al­ty-free un­til the World Health Or­ga­ni­za­tion de­clares the end of the Pub­lic Health Emer­gency of In­ter­na­tion­al Con­cern re­gard­ing COVID-19, or un­til a phar­ma­ceu­ti­cal prod­uct oth­er than remde­sivir or a vac­cine is ap­proved to treat or pre­vent COVID-19, whichev­er is ear­li­er.

Coun­tries like the US, Chi­na, South Ko­rea and Japan — where remde­sivir has al­ready been ap­proved — are not in­clud­ed from the deal. Gilead is ex­pect­ed to team up with “lead­ing chem­i­cal and phar­ma­ceu­ti­cal man­u­fac­tur­ing com­pa­nies” for most parts of Asia and Eu­rope. — Am­ber Tong

Chi­na’s lead­ing Covid-19 vac­cine man­u­fac­tur­er makes move in Cana­da

CanSi­no Bi­o­log­ics, the Chi­nese biotech that’s emerged at the head of a glob­al race for a Covid-19 vac­cine, will soon be bring­ing its ex­per­i­men­tal in­oc­u­la­tion to North Amer­i­ca.

CanSi­no and Cana­da’s Na­tion­al Re­search Coun­cil have agreed to col­lab­o­rate on a Phase I/II tri­al in the coun­try, with the goal of ramp­ing quick­ly in­to an ac­cel­er­at­ed Phase III study that can prove ef­fi­ca­cy. The agency said the deal in­cludes bio­pro­cess­ing and that the NRC would help scale up pro­duc­tion, al­though it was un­clear to what lev­el.

Al­though Mod­er­na, work­ing with the NIH, was the first to put their vac­cine in­to hu­mans, CanSi­no quick­ly emerged as the most clin­i­cal­ly ad­vanced ef­fort. Work­ing with the med­ical sci­ence arm of the Chi­nese mil­i­tary and with a tech­nol­o­gy that’s al­ready yield­ed a Chi­nese-ap­proved Ebo­la vac­cine, they were able to gain swift au­tho­riza­tion for a Phase II tri­al. Mod­er­na and a group at Ox­ford have both since joined them at that in­ter­me­di­ate ef­fi­ca­cy stage.

CanSi­no’s his­to­ry with the Cana­di­an re­search coun­cil goes back to 2013, the NRC said, when CanSi­no li­censed from the agency the cell lines it used to cre­ate its Ebo­la vac­cine and is now us­ing for Covid-19. Their ap­proach in­volves us­ing an ade­n­ovirus vec­tor to de­liv­er a gene for a coro­n­avirus anti­gen in­to hu­man cells. J&J and Ox­ford, along with a hand­ful of oth­er small­er ef­forts, both use a sim­i­lar tech­nol­o­gy. — Ja­son Mast

430 vac­cine and drugs aimed at Covid-19? Is that a mas­sive re­sponse or chaos?

The lat­est tal­ly and analy­sis by BIO, the biotech trade group, has tracked 430 unique com­pounds in de­vel­op­ment ei­ther to pro­tect against or treat Covid-19. US-based com­pa­nies are lead­ing the cam­paign with 207 pro­grams in var­i­ous stages of hu­man test­ing, they not­ed.

Chi­na lays claim to 31 pro­grams in de­vel­op­ment while the UK is home to 16 po­ten­tial weapons to fight the coro­n­avirus.

Break­ing down the to­tal num­ber in­to an­tivi­rals, treat­ments and vac­cines, BIO found while more than half of the an­tivi­rals and es­sen­tial­ly all vac­cines were new for the coro­n­avirus, as many as 63% of treat­ments were redi­rect­ed and an­oth­er 31% were re­pur­posed. — Am­ber Tong

Source: BIO

Click on the im­age to see the full-sized ver­sion

FDA looks to re­sume on-site in­spec­tions

As the White House pon­ders steps to re­open the coun­try, the FDA said it is col­lab­o­rat­ing with the CDC to “de­vel­op a process that would gov­ern how and where to re­turn to on-site fa­cil­i­ty sur­veil­lance in­spec­tions.”

The agency de­cid­ed in ear­ly March — one day be­fore the WHO would de­clare the Covid-19 out­break a pan­dem­ic — to post­pone most for­eign in­spec­tions. A week lat­er, it stopped vis­it­ing do­mes­tic fa­cil­i­ties too.

With the ex­cep­tion of “mis­sion crit­i­cal in­spec­tions,” reg­u­la­tors have been turn­ing to al­ter­na­tive tools for sur­veil­lance.

“Al­though in­spec­tions are crit­i­cal, they are one part of a ro­bust and mul­ti-pronged ap­proach to over­see­ing the safe­ty and qual­i­ty of FDA reg­u­lat­ed prod­ucts,” FDA com­mis­sion­er Stephen Hahn said in a state­ment. “Based on decades of ex­pe­ri­ence with our di­verse reg­u­lat­ed in­dus­tries, we be­lieve most FDA-reg­u­lat­ed firms un­der­stand and ap­pre­ci­ate their re­spon­si­bil­i­ty to en­sure the safe­ty of the prod­ucts they man­u­fac­ture or pro­duce. We con­sid­er these firms to be our part­ners in pub­lic health.” — Am­ber Tong

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.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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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.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

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.