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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.