Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As con­cerns rise around the J&J and As­traZeneca vac­cines, glob­al at­ten­tion is in­creas­ing­ly turn­ing to the lit­tle, 33-year-old, pro­duct­less, bank­rupt­cy-flirt­ing biotech that could: No­vavax.

In the now 16-month race to de­vel­op and de­ploy Covid-19 vac­cines, No­vavax has at times seemed like the pan­dem­ic’s most un­sus­pect­ing fron­trun­ner and at times like an over­hyped al­so-ran. Al­though they start­ed the pan­dem­ic with on­ly enough cash to last 6 months, they lever­aged old con­nec­tions and be­liev­ers in­to $2 bil­lion and emerged last sum­mer with da­ta ex­perts said sur­passed Pfiz­er and Mod­er­na. They un­veiled plans to quick­ly scale to 2 bil­lion dos­es. Then they couldn’t even make enough ma­te­r­i­al to run their US tri­al and watched four oth­er com­pa­nies beat them to the fin­ish line.

Two of those com­pa­nies, though, J&J and As­traZeneca, are fac­ing big ques­tions about the fu­ture of their vac­cines. While the US, UK and Eu­rope jumped to the front of the queue for mR­NA vac­cines, much of the world re­lied on the two Big Phar­mas and the over 4 bil­lion dos­es they promised to pro­duce in 2021. But both have faced per­sis­tent, oc­ca­sion­al­ly be­wil­der­ing, pro­duc­tion de­lays. And now ex­perts fear that con­cerns over a rare but se­ri­ous blood clot as­so­ci­at­ed with the two vac­cines could prompt coun­tries to sus­pend them or de­ter peo­ple around the globe from tak­ing them.

Steve Mor­ri­son

“Peo­ple are ex­treme­ly ner­vous about whether the [clots] are go­ing to throw J&J and As­traZeneca in­to a re­tract­ed sus­pen­sion,” says Steve Mor­ri­son, di­rec­tor of the glob­al health pol­i­cy cen­ter at the Cen­ter for Strate­gic and In­ter­na­tion­al stud­ies. “It’s too dif­fi­cult, it’s too ear­ly to judge. But peo­ple are very, very fright­ened about that.”

That, Mor­ri­son adds, now makes the tiny Mary­land-based biotech and their quixot­ic vac­cine quest all the more es­sen­tial for vac­ci­nat­ing the world. “Peo­ple are go­ing to be putting a lot more of a spot­light on No­vavax,” he says.

No­vavax shares some of the same at­trib­ut­es that led ex­perts to talk about As­traZeneca and J&J as glob­al vac­cines. Based on more tra­di­tion­al tech­nol­o­gy than mR­NA, the shot is eas­i­er to man­u­fac­ture, can be stored at nor­mal re­frig­er­a­tion tem­per­a­tures and de­liv­ered to re­mote and un­der-re­sourced re­gions.

As­traZeneca pro­vid­ed the back­bone for CO­V­AX, the WHO-Gavi ini­tia­tive to sup­ply vac­cines to poor­er coun­tries, promis­ing 550 mil­lion dos­es, in­clud­ing vir­tu­al­ly all of the shots they’ve shipped thus far. No­vavax pledged dou­ble that: 1.1 bil­lion dos­es —  each of which now looms larg­er as many of the As­traZeneca vac­cines CO­V­AX shipped sit on re­frig­er­a­tor shelves, un­used, around the world.

An­drea Tay­lor

“There was some con­cern that it might just hit the mar­ket too late and be un­nec­es­sary. But I think that’s no longer a con­cern,” An­drea Tay­lor, a re­searcher at Duke Uni­ver­si­ty’s Glob­al Health In­sti­tute who has been track­ing vac­cine pur­chas­ing agree­ments, says of No­vavax’s shot. “It will be re­al­ly im­por­tant.”

No­vavax, though, isn’t quite yet ready to shine. If the past few months have giv­en the world a crash course in vac­cine man­u­fac­tur­ing, No­vavax has pro­vid­ed the most in­ter­est­ing case study. In 2019, af­ter a set­back on their RSV vac­cine, the com­pa­ny sold off their on­ly fac­to­ry. They have since tried to pull off one of the most her­culean feats in the his­to­ry of in­dus­try: to go from a lit­tle-known, bare­ly sol­vent com­pa­ny with no ap­proved prod­ucts and no man­u­fac­tur­ing fa­cil­i­ties to a biotech that could an­nu­al­ly churn out 2 bil­lion dos­es of the world’s most sought af­ter prod­uct.

Amaz­ing­ly, it’s large­ly been a suc­cess. Fac­to­ries on three dif­fer­ent con­ti­nents are now churn­ing out or prepar­ing to churn out dif­fer­ent com­po­nents of No­vavax’s vac­cine, NVX-CoV2373. And the da­ta that have come back are strong: In a 15,000-per­son UK study, the vac­cine ap­peared as ef­fec­tive as the Pfiz­er-BioN­Tech and Mod­er­na shots: 96% ef­fec­tive against the orig­i­nal SARS-CoV-2 virus and 86% ef­fec­tive against the vari­ant now com­mon in the coun­try.

“Every­thing about it that’s in the pub­lic do­main looks promis­ing,” says John Moore, an im­mu­nol­o­gist at Cor­nell, who was so im­pressed by the ear­ly re­sults that he signed up for their Phase III tri­al. “The ques­tion is when is it go­ing to get ap­proved, and time­lines seem to be get­ting pushed back and it’s not ob­vi­ous why.”

At a time when gov­ern­ments and pub­lic health of­fi­cials are urg­ing vac­cine man­u­fac­tur­ers to scale, No­vavax has come up against the lim­its of what the world or any sin­gle com­pa­ny can han­dle. Vir­tu­al­ly overnight, they set up a net­work of out­side man­u­fac­tur­ers more am­bi­tious than one out­side ex­ec­u­tive said he’s ever seen, but they strug­gled at times to trans­fer their tech­nol­o­gy there amid pan­dem­ic trav­el re­stric­tions. They were kicked out of one fac­to­ry by the same gov­ern­ment that’s bankrolled their ef­fort. Com­pet­ing with larg­er com­peti­tors, they’ve found them­selves short on raw ma­te­ri­als as di­verse as Chilean tree bark and biore­ac­tor bags. They signed a deal with In­dia’s Serum In­sti­tute to pro­duce many of their CO­V­AX dos­es but now face the re­al­is­tic chance that even when Serum gets to full ca­pac­i­ty — and they are be­hind — In­dia’s gov­ern­ment, deal­ing with the world’s worst ac­tive out­break, won’t let the shots leave the coun­try.

No­vavax has said they will read out on their US tri­al and file for au­tho­riza­tion in the US and Eu­rope this quar­ter, but they have re­fused to say how many dos­es they have on hand if they get a reg­u­la­to­ry OK. CEO Stan­ley Er­ck first claimed last sum­mer they could start pro­duc­ing vac­cines at a rate of 2 bil­lion dos­es per year “very short­ly.” They’ve pushed that tar­get to Q3, al­though Tay­lor doubts they will hit it. They’re try­ing as hard as they can, but so is every­one else.

“There con­tin­ues to be a lot of con­cern that sup­ply isn’t be­ing in­creased fast enough,” says Ra­jeev Venkayya, head of vac­cines at Take­da, which has part­nered to pro­duce No­vavax’s shot.  “Peo­ple need to un­der­stand that this is not some­thing that is eas­i­ly scal­able to be­gin with, it’s al­ready been scaled to a greater de­gree and faster than has ever been done be­fore. And to do more just places greater risk on the en­tire sys­tem.”

Take­da’s pan­dem­ic in­fluen­za plant in Hikari, Japan, where the com­pa­ny is try­ing to man­u­fac­ture No­vavax dos­es

Click on the im­age to see the full-sized ver­sion

When No­vavax CBO John Trizzi­no called up an old col­league at Emer­gent BioSo­lu­tions in Feb­ru­ary of 2020, he wasn’t look­ing to pro­duce bil­lions of dos­es. On­ly a hand­ful of coro­n­avirus cas­es — it wasn’t yet called Covid-19 — had been con­firmed in the US, and Trizzi­no just need­ed some­one to build a few lots of the con­struct his re­search team had made. Emer­gent’s Bal­ti­more plant was just a short dri­ve from No­vavax’s head­quar­ters and the two had worked on projects to­geth­er be­fore.

John Trizzi­no

It would turn in­to the first strange twist in their man­u­fac­tur­ing ef­fort. Al­though Emer­gent pro­duced ma­te­r­i­al for the com­pa­ny’s suc­cess­ful Phase I/II tri­al, the fed­er­al gov­ern­ment no­ti­fied No­vavax over the sum­mer that they would have to move. Al­though the US was back­ing No­vavax’s shot, they deemed J&J a high­er pri­or­i­ty and in­stalled them at Emer­gent’s fa­cil­i­ties, push­ing the small­er com­pa­ny to Fu­ji­film-run plants in North Car­oli­na and Texas.

It seemed like a sig­nif­i­cant set­back when The Wash­ing­ton Post re­port­ed the move, one that pushed back their Phase III tri­al and cost them in the vac­cine race. But then this month word got out that Emer­gent had to de­stroy 15 mil­lion dos­es of J&J’s vac­cine af­ter mix­ing up in­gre­di­ents, the be­gin­ning of a scan­dal that led the FDA to shut down the whole plant this week. Sud­den­ly the cal­cu­lus looked a bit dif­fer­ent.

“It’s like the old fox­hole the­o­ry,” says Trizzi­no, who praised Emer­gent as a pro­fes­sion­al or­ga­ni­za­tion that hit a snag try­ing to scale rapid­ly. “You’re just glad it wasn’t you.”

By March, No­vavax’s am­bi­tions had grown. Er­ck, in­vit­ed to the Don­ald Trump vac­cine sum­mit at the White House, told the pres­i­dent that they want­ed to get to one bil­lion dos­es. “Frankly, we need mon­ey,” he said. “We need mon­ey to get scale.”

No­vavax would soon get that mon­ey, earn­ing $388 mil­lion from Coali­tion for Epi­dem­ic Pre­pared­ness in May and a $1.6 bil­lion con­tract from the Trump Ad­min­is­tra­tion’s Op­er­a­tion Warp Speed in June, the largest con­tract each en­ti­ty had giv­en out to that point. A Trump of­fi­cial told re­porters the size matched the as­sis­tance No­vavax, as a small­er com­pa­ny, need­ed in man­u­fac­tur­ing.

The CEPI fund­ing al­lowed No­vavax to ac­quire an old, 150,000-foot fa­cil­i­ty in the Czech Re­pub­lic that the Serum In­sti­tute had been us­ing to make po­lio vac­cines be­fore the Czech gov­ern­ment de­cid­ed that the po­lio vac­cine — a weak­ened, live virus that can on rare oc­ca­sions mu­tate back in­to path­o­gen­ic po­lio — was not some­thing they want­ed made in their bor­ders. The deal came with 150 em­ploy­ees and ca­pac­i­ty, the com­pa­ny said, to make 1 bil­lion dos­es.

Trizzi­no said the mon­ey ac­cel­er­at­ed talks that had al­ready be­gun. Be­hind the scenes, No­vavax had al­ready been lay­ing the ground­work for a ma­jor ex­pan­sion that, af­ter they got fund­ing, came to in­clude 10 dif­fer­ent part­ners on three con­ti­nents.

Mark Wom­ack

“Just the na­ture of how they put all of this to­geth­er,” says Mark Wom­ack, CBO of the CD­MO AGC Bi­o­log­ics. “I don’t think any­one’s ever seen any­thing like it.”

In ear­ly April, Wom­ack checked LinkedIn to find a mes­sage wait­ing for him. It was from Tim Hahn, a for­mer No­vavax CMC ex­ec­u­tive who the com­pa­ny had re­hired to help fig­ure out how to scale their vac­cine. Hahn ex­plained that he’d been ur­gent­ly try­ing to get in touch and that he had to call him now.

No­vavax’s shot con­sists of two com­po­nents. There’s the anti­gen, a syn­thet­ic copy of the coro­n­avirus spike pro­tein. Grown in in­sect cell lines, it pro­vides the core part of the vac­cine, train­ing the im­mune sys­tem to rec­og­nize and neu­tral­ize the virus. The Czech fa­cil­i­ty and the US Fu­ji­film fa­cil­i­ties are pro­duc­ing that com­po­nent. The sec­ond part is one of the old­est tools in vac­ci­na­tion, one the oth­er lead­ing Covid-19 can­di­dates don’t use: an ad­ju­vant, an ex­tra in­gre­di­ent meant to boost the body’s in­nate im­mune re­sponse.

No­vavax specif­i­cal­ly re­lies on an ex­tract from Chilean tree bark, which is then pack­aged in­to a fat par­ti­cle 40 bil­lionths of a me­ter in di­am­e­ter — a prod­uct they call Ma­trix-M. If No­vavax want­ed to make 2 bil­lion dos­es of vac­cine, they would al­so need to make 2 bil­lion of Ma­trix-M. And AGC had the fa­cil­i­ties to do it.

Over four days, Wom­ack said, the pair ham­mered an agree­ment that would nor­mal­ly take months. For­mal­ly an­nounced on June 4, the deal saw AGC re­pur­pose a line in their Copen­hagen fa­cil­i­ty to make 2 bil­lion dos­es of Ma­trix-M. Two months lat­er, af­ter No­vavax won fed­er­al back­ing, they added an­oth­er 1 bil­lion dos­es at a new build­ing in Seat­tle. In both cas­es, AGC reshuf­fled plans they had to use the fa­cil­i­ties for a mot­ley of oth­er bi­o­log­i­cal prod­ucts.

“They need­ed us to move at a speed that maybe no CD­MO, in the his­to­ry of our in­dus­try, ever had,” Wom­ack said.

That meant do­ing oth­er things dif­fer­ent­ly than just writ­ing an agree­ment in four days. AGC gen­er­al­ly ac­quired its own in­gre­di­ents. Now they would re­ly in part on in­gre­di­ents from No­vavax, and they would move for­ward on buy­ing new equip­ment and hir­ing dozens of new staff mem­bers with­out as­sur­ance they had been se­cured — which they some­times weren’t. The Chilean tree ex­tract, saponin, is a scarce com­mod­i­ty and they didn’t al­ways have a steady sup­ply.

Still, the com­pa­nies even­tu­al­ly man­aged to re­solve those and both the Seat­tle and Copen­hagen plants are churn­ing at full speed, en­cas­ing the ex­tract in fat to build two par­ti­cles, and send­ing them off to the com­pa­ny’s North Amer­i­can and Eu­ro­pean fill-fin­ish sites to be com­bined with the pro­tein and in­ject­ed in­to vials.

An overview of No­vavax’s Covid-19 sup­ply chain. “Just the na­ture of how they put all of this to­geth­er,” says Mark Wom­ack, CBO of the CD­MO AGC Bi­o­log­ics. “I don’t think any­one’s ever seen any­thing like it.”

Click on the im­age to see the full-sized ver­sion

Not every fa­cil­i­ty No­vavax en­list­ed is now on track. The com­pa­ny has been lim­it­ed both by the quan­ti­ty of se­lect raw ma­te­ri­als that the world has nev­er be­fore need­ed in such quan­ti­ties, and the speed at which they could con­duct tech trans­fer.

Tech trans­fer, one of many once-ob­scure words that of­fi­cials are now be­com­ing fa­mil­iar with, sim­ply refers to the process of one com­pa­ny set­ting up its pro­duc­tion process at an­oth­er com­pa­ny’s fa­cil­i­ties. For vac­cines, it’s a far more im­por­tant step than shar­ing patents or in­tel­lec­tu­al prop­er­ty, but it can be in­ten­sive. Mod­er­na CEO Stéphane Ban­cel has said part of the rea­son his com­pa­ny has not en­list­ed more out­side part­ners is that they don’t have enough trained per­son­nel to do so.

No­vavax had an ad­van­tage when it came to tech trans­fer. Their pro­tein-based tech­nol­o­gy is sim­i­lar to vac­cines, such as the he­pati­tis b shot, which is al­ready rou­tine­ly made around the world.  The com­pa­ny, Trizzi­no said, has re­lied on a sin­gle team of about a dozen peo­ple who have flown around the world to build up the vac­cine.

That might have worked out smooth­ly for one new fa­cil­i­ty. But the com­pa­ny is now try­ing to do it on an un­prece­dent­ed scale.

“The more part­ner­ships you add, you’re spread­ing this team thin­ner and thin­ner, which makes it hard­er to man­age the risk of each of these part­ner­ships,” says Venkayya of Take­da, speak­ing gen­er­al­ly about tech trans­fer. “This is go­ing to stretch any or­ga­ni­za­tion.”

Maria Bot­tazzi

Maria Bot­tazzi, as­so­ciate dean of the Na­tion­al School for Trop­i­cal Med­i­cine at Bay­lor, not­ed that No­vavax’s tech­nol­o­gy is not pre­cise­ly like old-fash­ioned pro­tein vac­cine: They turn the coro­n­avirus in­to a par­ti­cle-like shape. That makes it more vis­i­ble to the im­mune sys­tem but the process in­volved could make tech trans­fer more dif­fi­cult. She says the com­pa­ny may have been a bit too am­bi­tious with its pro­duc­tion tar­gets.

“The as­pi­ra­tion goal they have is great, but tech­nol­o­gy trans­fer is not easy,” says Bot­tazzi, who is help­ing de­vel­op a more tra­di­tion­al pro­tein-based vac­cine.

No­vavax signed a part­ner­ship with Take­da last sum­mer to pro­duce 250 mil­lion dos­es. Take­da opt­ed not to build its own Covid-19 shot as they fo­cused on bring­ing Dengue vac­cine to mar­ket, but they had fa­cil­i­ties to build some­one else’s vac­cine. In 2014, they won a Japan­ese gov­ern­ment grant to build 6,000 liters, two-sto­ry-high steel biore­ac­tors in their plant in the south­ern city of Hikari.

No­vavax’s sci­en­tists, though, haven’t been able to fly in­to Japan to do tech trans­fer be­cause of gov­ern­ment re­stric­tions. In­stead, the two man­u­fac­tur­ing teams have met re­mote­ly, try­ing to make sure that Take­da got iden­ti­cal equip­ment and raw ma­te­ri­als No­vavax used else­where, that their team is set up and could fol­low the ex­act same process, and they had the right qual­i­ty tests to make sure the fi­nal prod­uct is the same.

“You have to spend typ­i­cal­ly months, many months and thou­sands of per­son hours,” Venkayya said. “It’s very, very com­pli­cat­ed and a lot can go wrong.”

Take­da’s Ra­jeev Venkayya has been try­ing to set up No­vavax’s pro­duc­tion in Japan, al­though nei­ther he nor No­vavax’s team can en­ter the coun­try

Click on the im­age to see the full-sized ver­sion

Near­ly eight months af­ter Take­da and No­vavax signed an agree­ment, the Hikari fa­cil­i­ty is still not mak­ing vac­cines. And Venkayya said it may not be­gin pro­duc­tion this year.

The prob­lem is the same one that has af­fil­i­at­ed the globe: the sup­ply of raw ma­te­ri­als. Al­though No­vavax has es­tab­lished a man­u­fac­tur­ing net­work across the globe, they’re miss­ing key com­po­nents to keep it run­ning. That in­cludes sin­gle-use bags that en­case the in­sect cells when they’re in­side the biore­ac­tors. To get the Czech fa­cil­i­ty run­ning, Trizzi­no says, they al­so need a fil­ter that’s used through­out the pro­duc­tion process, in­clud­ing for pu­rifi­ca­tion.

Those de­lays have cost the com­pa­ny. Reuters re­port­ed in March that they forced the com­pa­ny to push back con­tract ne­go­ti­a­tions with the EU, as the Czech fa­cil­i­ty couldn’t make enough dos­es to sup­ply the con­ti­nent.

Matthew John­son

No­vavax ex­ec­u­tives and their part­ners at the Serum In­sti­tute have said the US gov­ern­ment is re­strict­ing ex­ports, al­though the re­al­i­ty is a bit more com­pli­cat­ed. There’s a short­age of both com­po­nents glob­al­ly as sup­ply chains strain un­der an un­prece­dent­ed vac­ci­na­tion ef­fort. The com­pa­nies that make fil­ters, for ex­am­ple, don’t have enough raw ma­te­ri­als to make them, says Matthew John­son, who leads cGMP at the Duke Hu­man Vac­cine In­sti­tute.

The De­fense Pro­duc­tion Act doesn’t di­rect­ly stop com­pa­nies that pro­duce com­po­nents from ex­port­ing them, but it re­quires them to give the gov­ern­ment pri­or­i­ty on or­ders, mean­ing sup­ply can con­tin­ue once the US has enough to pro­duce the vac­cines it’s or­dered but not enough but not un­til then.

“As long as they are ful­fill­ing their con­trac­tu­al agree­ments with the US, a De­fense Pro­duc­tion Act pri­or­i­ty rat­ing doesn’t im­pact what they do or how they en­gage in oth­er busi­ness,” a spokesper­son for HHS said in an email. “It is our le­gal oblig­a­tion to en­sure that a com­pa­ny on­ly us­es a De­fense Pro­duc­tion Act pri­or­i­ty rat­ing to sat­is­fy U.S. Gov­ern­ment or­ders.”

Trizzi­no said those is­sues should be re­solved by the sec­ond half of this year, at which point pub­lic health ex­perts hope it will join a con­tin­ued roll­out of J&J and As­traZeneca’s vac­cines. The EMA has in­sist­ed the ben­e­fits of the two vac­cines far out­weigh the risks, al­though coun­tries around the world are still de­lib­er­at­ing.

No­vavax may, how­ev­er, still face a dif­fer­ent ex­port ban at that point. The Serum In­sti­tute con­tract­ed to pro­duce 1 bil­lion dos­es of No­vavax’s vac­cine in 2021, many of which are des­ig­nat­ed for CO­V­AX. They’re al­ready be­hind, and ex­perts fear that In­dia could keep its ex­port ban on vac­cines in place even af­ter pro­duc­tion scales up.

Still, there are oth­er ways No­vavax’s vac­cine could get de­ployed around the world.  Al­though the biotech agreed to give the fed­er­al gov­ern­ment 100 mil­lion dos­es, Mor­ri­son not­ed that the US will like­ly have more Covid-19 vac­cine than it needs by the time No­vavax gets past the FDA. Ear­li­er this month, he au­thored a re­port call­ing among oth­er things for the fed­er­al gov­ern­ment to do­nate its ex­cess dos­es to for­eign gov­ern­ments.

He point­ed to the re­cent launch event for a new Co­v­ax dri­ve, where Gavi CEO Seth Berkley and oth­ers stressed the need not on­ly for com­pa­nies to sell but al­so for vac­ci­nat­ed coun­tries to do­nate dos­es.

“Their tone has changed,” Mor­ri­son said. “They are des­per­ate for do­nat­ed shares.”

The ar­ti­cle has been up­dat­ed to clar­i­fy No­vavax’s tri­al is ex­pect­ed to read out in Q2

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

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.