Covid-19 roundup: Cit­ing a lack of need, Gilead cuts remde­sivir study; No­vavax vac­cine pro­duc­tion slowed due to sup­ply short­ages

Gilead is halt­ing its remde­sivir study in high-risk, non-hos­pi­tal­ized Covid-19 pa­tients af­ter a de­ci­sion that the study no longer ad­dress­es an un­met need, a state­ment said.

The study’s stop­page is not due to ef­fi­ca­cy or safe­ty con­cerns, the com­pa­ny stat­ed.

“While COVID-19 con­tin­ues to im­pact many pa­tients and their loved ones, un­met med­ical needs have evolved over the course of the pan­dem­ic. The pri­ma­ry un­met need for non-hos­pi­tal­ized pa­tients with COVID-19 is for ef­fec­tive and con­ve­nient ther­a­pies that can be eas­i­ly ad­min­is­tered at home. Gilead re­mains com­mit­ted to de­vel­op­ing treat­ment op­tions for non-hos­pi­tal­ized pa­tients with COVID-19 that ad­dress this need,” a state­ment says.

Gilead is still de­vel­op­ing in­haled dosage forms of remde­sivir in hopes of de­liv­er­ing more con­ve­nient treat­ment.

The news comes as In­dia has an­nounced a ban on ex­ports of the drug, as sup­ply chain in­sta­bil­i­ty has rocked the na­tion. There are over 13 mil­lion con­firmed cas­es of Covid-19 in the coun­try, ac­cord­ing to the New York Times.

Vek­lury — the mar­ket­ed name of the drug — is used in more than half of hos­pi­tal­ized pa­tients with Covid-19, the com­pa­ny said. — Josh Sul­li­van

No­vavax vac­cine pro­duc­tion slowed due to sup­ply short­ages

Sup­ply short­ages have led to a de­lay in No­vavax’s time­line for full-speed Covid-19 vac­cine pro­duc­tion, ac­cord­ing to Reuters.

The Mary­land com­pa­ny hopes to hit a pro­duc­tion tar­get of 150 mil­lion dos­es a month, but sup­ply short­ages that in­clude bags used to grow cells are de­lay­ing that.

Three weeks ago, the com­pa­ny de­layed sign­ing a con­tract to pro­vide its vac­cine to the EU. A tem­po­rary US ban on ex­ports of crit­i­cal raw ma­te­ri­als could be, in part, re­spon­si­ble.

Pre­vi­ous­ly, No­vavax had said that it could ex­pect full-scale pro­duc­tion by May or June. The com­pa­ny has said that UK au­tho­riza­tion could come as soon as this month, and clear­ance from the US could be ex­pect­ed as ear­ly as May, Reuters re­port­ed. — Josh Sul­li­van

Rigel says da­ta show fos­ta­ma­tinib meets safe­ty end­point

Suc­cess in a small sam­ple size of da­ta has led sci­en­tists to de­clare pos­i­tive re­sults in a Phase II clin­i­cal tri­al of fos­ta­ma­tinib for the treat­ment of pa­tients hos­pi­tal­ized with Covid-19.

Rigel an­nounced that of the 59 pa­tients, three of them saw a re­duc­tion in se­ri­ous ad­verse ef­fects af­ter be­ing treat­ed with fos­ta­ma­tinib, com­pared to six pa­tients in the place­bo group.

The drug was well-tol­er­at­ed in hos­pi­tal­ized pa­tients with Covid-19 on oxy­gen, CMO Wolf­gang Dum­mer said in a state­ment. Af­ter 29 days, there were no deaths in the group giv­en fos­ta­ma­tinib, and there were three deaths in the place­bo group. Two in­tu­bat­ed pa­tients treat­ed with the drug saw im­proved symp­toms and came off of a ven­ti­la­tor with­in sev­en days of be­ing treat­ed, while two pa­tients on ven­ti­la­tors in the place­bo group both died.

The drug had pre­vi­ous­ly been ap­proved by the FDA as a sec­ond-line ther­a­py for throm­bo­cy­tope­nia in adult pa­tients with chron­ic im­mune throm­bo­cy­tope­nia. The drug is de­signed to block spleen ty­ro­sine ki­nase and re­duce an­ti­body-me­di­at­ed de­struc­tion of platelets. — Josh Sul­li­van

Kiniksa is back with new da­ta for its re­pur­posed treat­ment

About four months ago, Kiniksa’s re­pur­posed Covid-19 treat­ment whiffed on the pri­ma­ry end­point in the Phase II por­tion of a Phase II/III study. Now, the com­pa­ny is back with more da­ta that it says paints a brighter pic­ture for non-me­chan­i­cal­ly ven­ti­lat­ed pa­tients.

Kiniksa said on Mon­day that its mavril­i­mum­ab met the pri­ma­ry ef­fi­ca­cy end­point in a co­hort of pa­tients with se­vere Covid-19 pneu­mo­nia and hy­per­in­flam­ma­tion who were not me­chan­i­cal­ly ven­ti­lat­ed. The pro­por­tion of pa­tients alive and free of ven­ti­la­tion at Day 29 was 12.3 per­cent­age points high­er in the treat­ment arm com­pared to the place­bo arm,  ac­cord­ing to Kiniksa. The p-val­ue was 0.1224, which it says met a pre­de­fined sta­tis­ti­cal thresh­old of <0.2

Through Day 29, Kiniksa says mavril­i­mum­ab pa­tients ex­pe­ri­enced a 65% re­duc­tion in the risk of me­chan­i­cal ven­ti­la­tion or death (p=0.0175). Mor­tal­i­ty was 12.5 per­cent­age points low­er in mavril­i­mum­ab re­cip­i­ents (8%) com­pared to place­bo re­cip­i­ents (20.5%), with a p-val­ue of  0.0718, the com­pa­ny said.

“The re­sults from the Phase 2 por­tion of the Phase 2/3 tri­al of mavril­i­mum­ab in non-me­chan­i­cal­ly-ven­ti­lat­ed pa­tients with se­vere COVID-19 sig­ni­fy a po­ten­tial ad­di­tive treat­ment ef­fect of mavril­i­mum­ab on top of cor­ti­cos­teroids in re­duc­ing me­chan­i­cal ven­ti­la­tion and death in a di­verse pop­u­la­tion,” CMO John Paoli­ni said in a state­ment.

Back in De­cem­ber, Kiniksa said that 12 of  21 pa­tients giv­en mavril­i­mum­ab in the Phase II, or 57.1%, were alive and off oxy­gen af­ter two weeks, com­pared to 9 of 19 pa­tients (47.4%) on place­bo. That marked a rel­a­tive in­crease of 20.5%, but clocked in at a nom­i­nal p-val­ue of 0.536 — more than a full or­der of mag­ni­tude high­er than need­ed to prove sig­nif­i­cance.

At the time, Kiniksa point­ed to­ward an “en­cour­ag­ing trend” on the sec­ondary end­point, which al­so failed to meet sta­tis­ti­cal sig­nif­i­cance.  Af­ter four weeks, 20 of 21 pa­tients were alive and not suf­fer­ing from res­pi­ra­to­ry fail­ure, com­pared to 15 of 19 in the place­bo group. Kiniksa’s rel­a­tive in­crease in this in­stance was 20.7%, with a p-val­ue of 0.172.

Kiniksa has com­plet­ed en­roll­ment in the Phase II por­tion of the Phase II/III study, and is now en­rolling in Phase III. It’s cur­rent­ly in talks with the FDA and oth­er gov­ern­ment agen­cies about po­ten­tial paths for­ward, ac­cord­ing to a state­ment. — Nicole De­Feud­is 

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

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is expected to back an effort to expand vaccine manufacturing in Africa, unnamed officials told the Financial Times. 

Only 1% of Covid-19 vaccines administered worldwide have been given in Africa — down from 2% a few weeks ago, the WHO reported on Friday. The country normally gets many of its vaccine doses from the Serum Institute of India, which is now diverting its Covid-19 shots for domestic use.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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