Covid-19 roundup: J&J charts swift path to 1B vac­cine dos­es; Em­bassy ca­ble spot­lights pos­si­ble Wuhan lab con­nec­tion to coro­n­avirus

J&J, the first large phar­ma­ceu­ti­cal com­pa­ny to un­veil its per­for­mance in the first quar­ter, ac­knowl­edged the coro­n­avirus pan­dem­ic has had a sharp im­pact across its full-year guid­ance and of­fered some fresh de­tails on its Covid-19 vac­cine in de­vel­op­ment.

J&J, like its peers, is at­tempt­ing to do in six to 12 months what usu­al­ly takes 5 to 7 years, CEO Alex Gorsky re­mind­ed an­a­lysts on a con­fer­ence call on Mon­day.

The plan is to ini­ti­ate hu­man test­ing of its can­di­date by Sep­tem­ber, have safe­ty and da­ta by the end of the year, and have the vac­cine ready on a not-for-prof­it ba­sis for emer­gency pan­dem­ic use in ear­ly 2021, ex­ec­u­tives said, adding that they ex­pect to have the ca­pac­i­ty to gen­er­ate 600 to 900 mil­lion dos­es at the start of 2021 and ramp up to a bil­lion dos­es over the course of the year.

Source: J&J, 2020

Click on the im­age to see the full-sized ver­sion

The Band-Aid mak­ers’ cuts across its 2020 guid­ance were dri­ven ex­clu­sive­ly due to the un­cer­tain­ty sur­round­ing its med­ical de­vice busi­ness linked to de­ferred pro­ce­dures, ex­ec­u­tives stressed.

Source: J&J, 2020

Click on the im­age to see the full-sized ver­sion

“Our es­ti­mates of the Covid-19 im­pact as­sume the rel­a­tive shape of the Covid-19 curve as be­ing more of an acute short­er-term im­pact, rather than a pro­longed im­pact,” said CFO Joe Wolk, ex­plain­ing the ba­sis of the com­pa­ny’s re­vised 2020 pro­jec­tions.

The as­sump­tions at play here are a mid-to-late April peak; that the virus does re­turn with the “same in­ten­si­ty” in the fall, in that the world will be bet­ter pre­pared to test, iden­ti­fy and iso­late it, and ther­a­peu­tic op­tions may be avail­able; that elec­tive pro­ce­dures and doc­tor vis­its will large­ly be per­mis­si­ble in the sec­ond half of 2020 — with re­cov­ery for pro­ce­dures be­gin­ning in the third quar­ter and im­prov­ing fur­ther in the last quar­ter; and eco­nom­ic dis­rup­tions that have a knock-on ef­fect on em­ploy­ment and in­sur­ance cov­er­age could be­gin to im­prove in the sec­ond half of the year, he said.

Source: J&J, 2020

Click on the im­age to see the full-sized ver­sion

In the first quar­ter, glob­al sales of the com­pa­ny’s med­ical de­vices al­so fell near­ly 5% year-over-year as the coro­n­avirus cri­sis de­ferred med­ical pro­ce­dures in ar­eas such as or­tho­pe­dics and oph­thal­mol­o­gy. The ap­petite for med­ical de­vices will be un­cer­tain over the course of the year, the com­pa­ny said.

“We be­lieve hos­pi­tal sys­tems will have the ca­pac­i­ty to make up dif­fer­ent pro­ce­dures from ear­li­er in the year, but we sus­pect it could take time for pa­tients to get com­fort­able sched­ul­ing an elec­tive pro­ce­dure, hos­pi­tals and sur­geons may still be re­cov­er­ing from peak Covid-19 im­pact,” Wolk said. “And there will be eco­nom­ic chal­lenges we dis­cussed ear­li­er, name­ly a po­ten­tial im­pact on the num­ber of in­sured pa­tients, and a chang­ing pri­or­i­ti­za­tion of in­come in the near term. Those fac­tors lead us to as­sume a re­cov­ery in a range of ze­ro per­cent to 15%.”

Con­verse­ly, J&J’s over-the-counter and con­sumer prod­ucts busi­ness saw some growth, as hoard­ing and stock­ing up be­hav­ior saw an uptick in the quar­ter. How­ev­er, these gains are ex­pect­ed to cor­rect over the year, al­though de­mand for the com­pa­ny’s sun­screen prod­ucts will un­der­stand­ably slow.

Even the phar­ma­ceu­ti­cal busi­ness saw a mar­gin­al ben­e­fit as providers stocked up on 90-day sup­plies ver­sus the pre­vi­ous 30-day par­a­digm in the quar­ter, apart from gains in mar­ket share that were mar­gin­al­ly off­set by biosim­i­lar and gener­ic com­pe­ti­tion. J&J ex­pects a “small lev­el of dis­rup­tion” as­so­ci­at­ed with de­layed di­ag­noses and new pa­tient starts in the com­ing months. Still, the sta­tus of its 2020 pro­ject­ed reg­u­la­to­ry fil­ings re­main in­tact, the com­pa­ny said, un­der­scor­ing that it has not re­ceived no­ti­fi­ca­tions from reg­u­la­to­ry au­thor­i­ties on any po­ten­tial de­lays.

As ex­pect­ed, the com­pa­ny stuck by its div­i­dend, in­deed lift­ing it for the 58th con­sec­u­tive year, but dis­closed that it was not plan­ning to en­gage in any stock re­pur­chase pro­gram for the fore­see­able fu­ture. Mean­while, while it is plan­ning to hold off on di­vesti­tures giv­en the fi­nan­cial en­vi­ron­ment, the com­pa­ny did in­di­cate that it is still shop­ping for deals.

“The cur­rent cri­sis does not re­duce our de­sire to do these trans­ac­tions. In fact, giv­en our fi­nan­cial strength, we may be in a bet­ter po­si­tion to find op­por­tu­ni­ties that will aug­ment sus­tain­able long term growth,” Wolk said.

— Na­tal­ie Grover

The­o­ries that the coro­n­avirus orig­i­nat­ed in a Wuhan lab are re­vived by warn­ings from US em­bassy — re­port

The no­tion that the coro­n­avirus orig­i­nat­ed in a lab in Wuhan took root ear­ly in the brew­ing pan­dem­ic, spread on­line and nev­er com­plete­ly died out — de­spite re­peat­ed as­sur­ances that the virus is of an­i­mal ori­gin and was not en­gi­neered in a lab.

Now re­ports are cir­cu­lat­ing that US Em­bassy of­fi­cials in Chi­na sent back a pair of of­fi­cial warn­ings about a lack of biosafe­ty mea­sures at one of the sus­pect­ed re­search fa­cil­i­ties where re­searchers car­ried out work on bat coro­n­avirus­es. And that rais­es the pos­si­bil­i­ty — I’ll em­pha­size pos­si­bil­i­ty — that the virus may have es­caped the lab.

The lab is the Wuhan In­sti­tute of Vi­rol­o­gy, which Wash­ing­ton Post colum­nist Josh Ro­gin notes re­ceived the high­est biose­cu­ri­ty lev­el rat­ing 5 years ago — a first in Chi­na. Re­searchers at the cen­ter led by Shi Zhengli were study­ing bat coro­n­avirus­es linked to SARS. The oth­er lab that has at­tract­ed at­ten­tion is the Wuhan Cen­ter for Dis­ease Con­trol and Pre­ven­tion.

An ear­ly 2018 ca­ble from the em­bassy re­port­ed:

“Dur­ing in­ter­ac­tions with sci­en­tists at the WIV lab­o­ra­to­ry, they not­ed the new lab has a se­ri­ous short­age of ap­pro­pri­ate­ly trained tech­ni­cians and in­ves­ti­ga­tors need­ed to safe­ly op­er­ate this high-con­tain­ment lab­o­ra­to­ry.”

The Chi­nese sci­en­tists re­port­ed on their work in a pa­per ti­tled: “Dis­cov­ery of a rich gene pool of bat SARS-re­lat­ed coro­n­avirus­es pro­vides new in­sights in­to the ori­gin of SARS coro­n­avirus.”

And that has US of­fi­cials buzzing about a pos­si­ble con­nec­tion to Covid-19, Ro­gin re­ports.

The Chi­nese gov­ern­ment has re­port­ed its the­o­ry that the out­break be­gan at a Wuhan fish mar­ket. But since then the Post colum­nist says that the Chi­nese have locked down any in­fo on the source of the virus.

The WIV, mean­while, in­sists it had no con­nec­tion to the out­break and weeks ago their sci­en­tists said that the 2019-nCoV virus was a bat-de­rived coro­n­avirus.

Just an­oth­er con­spir­a­cy the­o­ry? Per­haps. But Ro­gin thinks it’s a lead that ought to be fol­lowed in de­ter­min­ing ex­act­ly where the virus orig­i­nat­ed, with an eye to pre­vent­ing any re-oc­cur­rence, whether man-made or na­ture-made. — John Car­roll

GSK, Sanofi en­ter pact to co-de­vel­op vac­cine

British drug­mak­er GSK, whose vac­cine ad­ju­vant tech­nol­o­gy is al­ready be­ing used by two Chi­nese com­pa­nies and an Aus­tralian uni­ver­si­ty as the groups de­vel­op Covid-19 vac­cines, is now join­ing forces with its French peer Sanofi to work on a vac­cine.

The Eu­rope-based drug­mak­ers will join a cadre of oth­ers — in­clud­ing Mod­er­na, Pfiz­er and a pla­toon of aca­d­e­m­ic groups — fever­ish­ly work­ing on a weapon that could rel­e­gate the of­ten life-threat­en­ing ill­ness to the an­nals of the past.

Sanofi’s re­com­bi­nant DNA tech­nol­o­gy, which is the ba­sis of the com­pa­ny’s li­censed in­fluen­za prod­uct in the Unit­ed States, is set to make the Covid-19 vac­cine more po­tent and eas­i­er to man­u­fac­ture at scale with the ad­di­tion of GSK’s ad­ju­vant. The can­di­date is ex­pect­ed to en­ter hu­man tri­als in the sec­ond half of this year and, if suc­cess­ful, the com­pa­nies aim to com­plete the de­vel­op­ment re­quired for de­ploy­ment by the sec­ond half of 2021.

De­fin­i­tive terms of the pact, which joins two of the world’s largest vac­cine com­pa­nies, will be ironed out over the com­ing weeks.

Sanofi al­so has two oth­er Covid-19 projects in its reper­toire. In Feb­ru­ary, the com­pa­ny said it was de­vel­op­ing a Covid-19 vac­cine can­di­date in part­ner­ship with BAR­DA, us­ing its egg-free, re­com­bi­nant DNA plat­form and work from a pre­vi­ous SARS vac­cine. The fol­low­ing month, Sanofi un­veiled it was part­ner­ing with Trans­late Bio to cre­ate an mR­NA vac­cine can­di­date for Covid-19. — Na­tal­ie Grover

As­traZeneca kicks off Calquence tri­al against Covid-19

Months af­ter scor­ing ex­pand­ed ap­proval for its BTK in­hibitor Calquence, As­traZeneca has an­nounced it will be test­ing the ther­a­py in a tri­al de­signed to eval­u­ate the agent’s ef­fect on mor­tal­i­ty and di­min­ish­ing the need for as­sist­ed ven­ti­la­tion in pa­tients with life-threat­en­ing Covid-19 symp­toms.

As­traZeneca’s Calquence be­longs to a fam­i­ly of drugs that thwart Bru­ton’s ty­ro­sine ki­nase, an en­zyme that plays a role in onco­genic sig­nal­ing and the rise of some leukemic cells. It is a sec­ond-gen­er­a­tion BTK in­hibitor, de­signed to be a safer and more tol­er­a­ble op­tion for cer­tain blood can­cer pa­tients, ver­sus J&J and Ab­b­Vie’s first it­er­a­tion — Im­bru­vi­ca — which has gen­er­at­ed bil­lions in sales, but car­ries sig­nif­i­cant side-ef­fects.

Ear­ly clin­i­cal da­ta sug­gest Calquence in­duces di­min­ished in­flam­ma­tion and re­duces the sever­i­ty of Covid-19-re­lat­ed res­pi­ra­to­ry dis­tress, the com­pa­ny said, adding that the im­pact of the drug will be mea­sured in hos­pi­tal­ized pa­tients both in­side and out­side ICUs. — Na­tal­ie Grover

Chi­na green­lights two more vac­cine tri­als

In mid-March, Chi­na’s CanSi­no Bi­o­log­ics be­came one of the fron­trun­ners in the race to de­vel­op a Covid-19 vac­cine. Now, two oth­er Chi­nese drug­mak­ers have se­cured ap­proval to kick off hu­man test­ing for their re­spec­tive vac­cine can­di­dates.

The ex­per­i­men­tal vac­cines were de­vel­oped by Wuhan In­sti­tute of Bi­o­log­i­cal Prod­ucts un­der the Chi­na Na­tion­al Phar­ma­ceu­ti­cal Group (Sinopharm), and Bei­jing-based com­pa­ny Sino­vac Re­search and De­vel­op­ment. Tri­als have be­gun, news agency Xin­hua re­port­ed on Tues­day.

Un­like CanSi­no’s re­com­bi­nant ade­n­ovirus vec­tor vac­cine, these two com­pa­nies are de­vel­op­ing in­ac­ti­vat­ed vac­cines in which dead pathogens, in this case SARS-CoV-2, are used to en­hance im­muno­genic­i­ty. Such vac­cines al­ready ex­ist to pro­tect against dis­eases such as he­pati­tis A and in­fluen­za.

Sinopharm, which is al­so work­ing on an­oth­er in­ac­ti­vat­ed vac­cine and a ge­net­i­cal­ly en­gi­neered vac­cine for Covid-19, has set aside $142 mil­lion for its vac­cine re­search. Sino­vac, which has ex­pe­ri­ence de­vel­op­ing a SARS vac­cine, has shown promis­ing cross-neu­tral­iza­tion re­ac­tion to dif­fer­ent Covid-19 strains, the re­port said. — Na­tal­ie Grover

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

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.