Stéphane Bancel, Getty

Covid-19 roundup: Mod­er­na inks fill-fin­ish pact with Sam­sung Bi­o­log­ics; So­ri­ot dis­cuss­es vac­cine woes, says shot 'has a fu­ture' — re­port

As Mod­er­na has ramped up its man­u­fac­tur­ing ca­pa­bil­i­ties and looks to dis­trib­ute its vac­cine dos­es to coun­tries in dire need, the com­pa­ny has inked a deal with South Ko­re­an CD­MO Sam­sung Bi­o­log­ics for fill-fin­ish du­ties.

Sam­sung’s pro­duc­tion line in In­cheon will sup­port the pro­duc­tion of 100s of mil­lions of dos­es, good for dis­tri­b­u­tion at the start of Q3. Ko­rea has se­cured 40 mil­lion dos­es of the vac­cine.

Mod­er­na an­nounced Fri­day that its vac­cine was ap­proved by the Japan­ese and South Ko­re­an gov­ern­ments. Dis­tri­b­u­tion will hap­pen in Japan im­me­di­ate­ly, with the help of Take­da, as a part of a 3-way agree­ment. No­vavax will help man­u­fac­ture the jab in Japan.

Sam­sung’s stock rose as much as 5.2% af­ter the con­tract was an­nounced.

The move comes as vac­cine mak­ers make the push to get dos­es to Asia. Last week, Ger­many’s BioN­Tech, which col­lab­o­rat­ed with Pfiz­er on its vac­cine, an­nounced that the com­pa­ny will set roots down with an Asia re­gion­al head­quar­ters in Sin­ga­pore as the de­mand for mR­NA vac­cines has sky­rock­et­ed.

In late April, Mod­er­na an­nounced its plans to tur­bocharge its sup­ply chain and up its glob­al com­mit­ment to 3 bil­lion dos­es in 2022, dou­bling ca­pac­i­ty at con­tract sites in Switzer­land and Spain run by Lon­za and Rovi, re­spec­tive­ly, and in­creas­ing drug sub­stance man­u­fac­tur­ing by 50% at its US fa­cil­i­ties. The ex­pan­sions will al­so al­low Mod­er­na to now pro­duce be­tween 800 mil­lion and 1 bil­lion dos­es in 2021, the com­pa­ny said.

That move was in­spired, ac­cord­ing to CEO Stéphane Ban­cel in a pre­vi­ous in­ter­view with End­points News, to pro­vide dos­es and boost­ers to coun­tries in need.

“We said ‘what can we do for the world?’ and we ba­si­cal­ly went back to our board and said ‘we need to do mas­sive in­vest­ment,’” Ban­cel told End­points. “We need to aim to in­crease our ca­pac­i­ty for next year so that we can make sure we can vac­ci­nate and boost every­body.” — Josh Sul­li­van

Pas­cal So­ri­ot says As­traZeneca vac­cine ‘has a fu­ture’ in new in­ter­view

As­traZeneca has had its share of speed bumps re­gard­ing de­vel­op­ment for its Covid-19 vac­cine, and CEO Pas­cal So­ri­ot dished on some of the set­backs and opined on the shot’s fu­ture in a new in­ter­view with the Fi­nan­cial Times.

Among the high­lights? So­ri­ot be­lieves the com­pa­ny’s vac­cine “has a fu­ture” giv­en the sheer num­ber of coun­tries around the world that are sign­ing up for de­liv­er­ies. He al­so dis­cussed the dis­par­i­ty be­tween the vac­cine’s roll­out in the UK com­pared to the rest of Eu­rope, and re­ferred to the much-ma­ligned US Phase III da­ta re­lease as an “own goal.”

The com­ments were his first since the Eu­ro­pean Com­mis­sion said it would pur­sue le­gal ac­tion against the com­pa­ny over a short­fall in vac­cine de­liv­er­ies.

“I’m a Eu­ro­pean so I love Eu­rope, don’t get me wrong,” he told FT. “But at the end of the day Eu­rope is part of the world, it’s not the whole world. And there are many coun­tries around the world who ac­tu­al­ly want this vac­cine, so this vac­cine has a fu­ture.”

One of the rea­sons be­hind many of the EU coun­tries’ frus­tra­tions had been the UK’s pri­or­i­ty ac­cess to the vac­cine. So­ri­ot re­it­er­at­ed that the coun­try had been grant­ed such ac­cess as part of the agree­ment it signed with Ox­ford Uni­ver­si­ty be­fore the Big Phar­ma part­nered to help man­u­fac­ture and dis­trib­ute the shot.

He praised the UK’s de­ci­sion to ap­point some­one from the in­dus­try to run the coun­try’s vac­cine roll­out in Kate Bing­ham, a ven­ture cap­i­tal­ist. But he stopped short of crit­i­ciz­ing the EU di­rect­ly over whether it should have tak­en a sim­i­lar tac­tic.

Among As­traZeneca’s high-pro­file stum­bles came back in March, when the com­pa­ny re­port­ed its Phase III in­ter­im re­sults. Af­ter the com­pa­ny paint­ed a good pic­ture in a press re­lease, the NIH pub­lished an ex­tra­or­di­nary state­ment say­ing the com­pa­ny may have in­clud­ed out­dat­ed da­ta in its re­sults.

NI­AID chief An­tho­ny Fau­ci had called the move an “un­forced er­ror” at the time, and So­ri­ot ap­peared to agree with his “own goal” com­ment. Ac­cord­ing to So­ri­ot’s ac­count­ing of the or­deal, re­searchers were rush­ing to get out the da­ta and sim­u­lat­ed what the fi­nal re­sults would look like while for­get­ting to in­form the DSMB.

“It is not typ­i­cal­ly nec­es­sary but out of po­lite­ness and out of good prac­tice, they should have told them,” So­ri­ot said. “Peo­ple have worked so hard, they were tired, they were rush­ing.” — Max Gel­man

No­vavax to ex­plore dual flu-Covid-19 vac­cine with SK bio­sciences

No­vavax, SK Bio­science and the Ko­re­an min­istry of health have signed an agree­ment to ex­plore the de­vel­op­ment of No­vavax’s Covid-19 vac­cine.

The deal was an­nounced in a cer­e­mo­ny host­ed by South Ko­re­an Pres­i­dent Moon Jae-in. It ex­pands on a deal that was in­tend­ed to pro­vide broad ac­cess to NVX-CoV2373 glob­al­ly. As a part of the agree­ment, SK and No­vavax will ex­plore vac­cines that com­bat Covid-19 vari­ants and the pos­si­bil­i­ty of a vac­cine that would fight both Covid-19 and the flu.

NVX-CoV2373 is in 2 piv­otal Phase III tri­als: 1 in the UK that demon­strat­ed 96.4% ef­fi­ca­cy against the orig­i­nal virus strain and 86.3% ef­fi­ca­cy against the vari­ants, and a US/Mex­i­co PRE­VENT-19 tri­al.

SK Bio­science be­gan the sub­mis­sion process for the vac­cine to the South Ko­re­an gov­ern­ment in April.

First pa­tients in Pfiz­er 20vP­nC tri­al have been jabbed 

The first of 600 adults that will re­ceive a dose of the Pfiz­er-BioN­Tech 20-va­lent pneu­mo­coc­cal con­ju­gate vac­cine have re­ceived their jab, Pfiz­er an­nounced Mon­day.

The tri­al is ex­plor­ing the co-ad­min­is­tra­tion of 20vP­nC with a boost­er dose of the Pfiz­er-BioN­Tech vac­cine that’s been ap­proved by the FDA. It will de­scribe safe­ty when the vac­cines are co-ad­min­is­tered, and fol­low up 6 months af­ter vac­ci­na­tion, the com­pa­ny said.

The pa­tients will be a part of 1 of 3 groups. The first group will re­ceive the 20vP­nC vac­cine plus the Pfiz­er-BioN­Tech boost­er. The sec­ond will re­ceive 20vP­nC and a place­bo, and the third will re­ceive the Pfiz­er-BioN­Tech jab and a boost­er.

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.