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.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

NIH director Francis Collins at a Senate Appropriations subcommittee hearing for Operation Warp Speed (Graeme Jennings/Pool via AP Images)

Covid-19 roundup: As­traZeneca signs 400M vac­cine sup­ply deal with EU; Sinopharm re­ports pos­i­tive Phase I/II da­ta for vac­cine can­di­date

Amid talks with multiple players, the European Commission has reached its first vaccine supply deal with AstraZeneca, securing 400 million doses of the Oxford candidate for all of its member countries.

The pharma giant said in a press release that the deal builds on the existing agreement with Germany, France, Italy and the Netherlands, announced in June. It was unclear, however, whether that means simply extending the same 400 million doses to all EU countries or doubling the reservation to 800 million doses.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.