Covid-19 roundup: No­vavax shakes up lead­er­ship with two pro­mo­tions and de­par­ture of CFO; Mod­er­na, No­vavax shots added to mix-and-match study in the UK

No­vavax has had a busy month, filled with sup­ply chain is­sues and man­u­fac­tur­ing deals that have af­fect­ed the roll­out of its Covid-19 vac­cine. Tues­day, the com­pa­ny an­nounced up­dates to its lead­er­ship team.

Greg Covi­no

CFO Greg Covi­no will step down from that role af­ter just five months for per­son­al rea­sons, the re­lease said, but take on a new role as ex­ec­u­tive ad­vi­sor. John Trizzi­no, cur­rent chief com­mer­cial of­fi­cer and chief busi­ness of­fi­cer, will take the CFO role over in the in­ter­im.

The Mary­land com­pa­ny al­so an­nounced the pro­mo­tion of Gale Smith and the ap­point­ment of Troy Mor­gan. Smith takes over the roles of chief sci­en­tist and SVP of dis­cov­ery and pre­clin­i­cal re­search, while Mor­gan be­comes chief com­pli­ance of­fi­cer in a new­ly cre­at­ed po­si­tion.

Smith has been with No­vavax since 2004, and holds patents for the bac­ulovirus-in­sect cell ex­pres­sion sys­tem as well as sea­son­al in­fluen­za vac­cines and ad­ju­vants. He’s over­seen dis­cov­ery and pre-clin­i­cal re­search since his start with the com­pa­ny, and played a sig­nif­i­cant role in the dis­cov­ery of No­vavax’s Covid-19 vac­cine. Pres­i­dent of R&D Gre­go­ry Glenn said in a state­ment:

Dr. Smith’s sci­en­tif­ic in­sights and lead­er­ship are an in­valu­able as­set to No­vavax and have al­ready de­liv­ered vac­cines that pro­tect the health of mil­lions world­wide. This well-de­served pro­mo­tion re­flects not on­ly his ma­jor con­tri­bu­tions in cre­at­ing our COVID-19 vac­cine can­di­date, but well over a decade of ded­i­ca­tion to im­prov­ing our tech­nol­o­gy plat­form.

Mor­gan comes to No­vavax from EMD Serono, where he held the same role of CCO. Be­fore that, he held roles in se­nior lead­er­ship at Mer­ck KGaA, Sanofi and Bio­gen.

“We wel­come Troy’s spe­cial­ized ex­per­tise in glob­al com­pli­ance reg­u­la­tions and re­quire­ments as we look to­ward com­mer­cial­iza­tion and work to ef­fi­cient­ly de­liv­er our vac­cine around the world in the fight against the COVID-19 pan­dem­ic,” CEO Stan­ley Er­ck said.

Re­cent sup­ply short­ages have led to a de­lay in No­vavax’s time­line for full-speed Covid-19 vac­cine pro­duc­tion, ac­cord­ing to Reuters. The com­pa­ny has the goal of hit­ting a pro­duc­tion tar­get of 150 mil­lion dos­es a month, but sup­ply short­ages that in­clude bags used to grow cells have de­layed that.

That news came about a week af­ter the com­pa­ny an­nounced that it would al­low its place­bo group to re­ceive its Covid-19 vac­cine. In March, a UK tri­al showed a fi­nal ef­fi­ca­cy of 96% against mild, mod­er­ate and se­vere Covid-19 cas­es in the UK, but the vac­cine fal­tered against the South African vari­ant, where it reg­is­tered 50% ef­fi­ca­cy.

No­vavax has pledged 60 mil­lion dos­es of its shot to the UK as part of a deal signed in Au­gust.

Mod­er­na, No­vavax shots added to mix-and-match study in the UK

Shots from Mod­er­na and No­vavax have been added to a study that looks to mix and match two dif­fer­ent Covid-19 vac­cines, Reuters re­ports.

The study in the UK is known as COM-COV and was launched in Feb­ru­ary to see if mix­ing up shots from dif­fer­ent drug­mak­ers elic­its an ad­e­quate im­mune re­sponse, with the pur­pose of us­ing the ex­ist­ing vac­cines more flex­i­bly.

The study al­ready in­cludes the Pfiz­er and As­traZeneca vac­cines with vol­un­teers re­ceiv­ing a dose of ei­ther of those drugs be­fore be­ing ran­dom­ized to take a sec­ond shot of the same vac­cine or one of Mod­er­na or No­vavax. The study has en­rolled 1,050 pa­tients, Reuters said.

Re­sults from the tri­al are ex­pect­ed as soon as April or May.

Re­ports of rare blood clots have led to skep­ti­cism in some Eu­ro­pean gov­ern­ments, in­clud­ing France and Ger­many. Those coun­tries have lim­it­ed what age groups are per­mit­ted to re­ceive that jab.

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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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.

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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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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