President Biden (AP Images)

Covid-19 roundup: Pfiz­er, Mod­er­na say Biden's goal of hav­ing 600M dos­es by Ju­ly is with­in sight; EMA to con­sid­er ex­pand­ing remde­sivir au­tho­riza­tion

Pfiz­er and Mod­er­na are on track to de­liv­er a com­bined 220 mil­lion dos­es of their mR­NA vac­cines in the US by the end of March, the com­pa­nies told a con­gres­sion­al com­mit­tee, set­ting them up to of­fer enough shots to vac­ci­nate 300 mil­lion Amer­i­cans by the end of Ju­ly — a goal Pres­i­dent Joe Biden has out­lined in re­cent days.

John Young

Pre­vi­ous­ly, sup­ply wasn’t sup­posed to reach that lev­el un­til Sep­tem­ber.

Both drug­mak­ers say the new goal re­flects sig­nif­i­cant ex­pan­sions in their man­u­fac­tur­ing ca­pac­i­ty. And J&J said it could come in with mil­lions of its one-shot vac­cine if the FDA au­tho­rizes that third op­tion fol­low­ing an ad­comm sched­uled lat­er this week.

In a pre­pared tes­ti­mo­ny, Pfiz­er CBO John Young not­ed that it’s al­ready shipped around 40 mil­lion dos­es of its BioN­Tech-part­nered vac­cine so far. Thanks to im­prove­ments and ex­pan­sions, by mid-March it could be sup­ply­ing 13 mil­lion dos­es per week; for com­par­i­son, the week­ly num­bers were around 4 to 5 mil­lion in ear­ly Feb­ru­ary.

At Mod­er­na, Pres­i­dent Stephen Hoge tells a sim­i­lar sto­ry:

We have dou­bled our month­ly de­liv­er­ies since late 2020, and we are aim­ing to dou­ble them again by April to more than 40 mil­lion dos­es per month. Based on this progress scal­ing up man­u­fac­tur­ing, we re­cent­ly agreed to move up our de­liv­ery time­line: we now are aim­ing to de­liv­er a sec­ond hun­dred mil­lion dos­es by the end of May and a third hun­dred mil­lion dos­es by the end of Ju­ly.

Stephen Hoge

Break­ing down the mul­ti­ple steps it takes to make an mR­NA vac­cine, he adds that Mod­er­na is in the process of on­board­ing a sec­ond fill-fin­ish part­ner with a US fa­cil­i­ty that, like Catal­ent, would be putting mR­NA-1273 in­to vials. — Am­ber Tong

EMA to con­sid­er ex­pand­ing remde­sivir au­tho­riza­tion

Gilead’s remde­sivir is au­tho­rized in Eu­rope for Covid-19 pa­tients re­quir­ing oxy­gen, but the EMA is look­ing in­to ex­pand­ing that ac­cess.

Eu­ro­pean reg­u­la­tors have start­ed con­sid­er­ing whether or not remde­sivir, sold un­der the brand name Vek­lury, should be used in cas­es where pa­tients don’t need sup­ple­men­tal oxy­gen. The EMA’s CHMP body will is­sue an opin­ion on the mat­ter some­time be­fore the sum­mer af­ter Gilead sub­mit­ted new da­ta, reg­u­la­tors said Mon­day.

Remde­sivir was first au­tho­rized on the con­ti­nent back in Ju­ly, and any po­ten­tial en­dorse­ments by the EMA will have to be for­mal­ly OK’ed by the Eu­ro­pean Com­mis­sion.

The drug end­ed up the win­ner of the Covid-19 treat­ment race, de­spite some deep skep­ti­cism over its ef­fec­tive­ness. Gilead re­ceived full ap­proval for Vek­lury in the US last Oc­to­ber, with a la­bel for treat­ment in adults and chil­dren old­er than 12 in Covid-19 cas­es that re­quire hos­pi­tal­iza­tion.

But that green light came less than a week af­ter a WHO study said the drug had lit­tle, if any, ef­fect on im­prov­ing mor­tal­i­ty rates, re­duc­ing the amount of pa­tients need­ing ven­ti­la­tors or short­en­ing hos­pi­tal stays. That led to the UN or­ga­ni­za­tion rec­om­mend­ing against its use in No­vem­ber, cit­ing the lim­it­ed da­ta and high costs as­so­ci­at­ed with the drug.

Remde­sivir has al­ready brought in a for­tune for Gilead, hav­ing net­ted near­ly $2 bil­lion in sales in last year’s fourth quar­ter alone. The drug­mak­er has priced a five-dose reg­i­men of Vek­lury at $3,120. — Max Gel­man

BioN­Tech stock is keep­ing Biden ad­vis­er Er­ic Lan­der out of cer­tain Covid-19 vac­cine dis­cus­sions

Er­ic Lan­der

A Sen­ate con­fir­ma­tion isn’t the on­ly hur­dle stand­ing be­tween Er­ic Lan­der and his new job as Pres­i­dent Joe Biden’s top sci­en­tif­ic ad­vis­er.

There’s al­so the stock he owns in BioN­Tech — worth be­tween $500,000 and $1 mil­lion — and a port­fo­lio of oth­er bio­phar­ma com­pa­nies that he plans to di­vest if con­firmed, Ax­ios re­port­ed.

While Lan­der, the found­ing di­rec­tor of the Broad In­sti­tute, is al­ready ad­vis­ing the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy, he’s re­cused from “par­tic­u­lar mat­ters re­lat­ed to any stocks he holds pend­ing di­vesti­ture, in­clud­ing any such mat­ters re­lat­ed to COVID vac­cines,” a White House spokesper­son told the out­let.

He dis­closed his stock own­er­ship in pa­per­work made pub­lic on Mon­day. Among the oth­er drug­mak­ers he has a stake in are Co­di­ak Bio­Sciences, an ex­o­some play­er he co-found­ed. The biotech has al­so in­di­cat­ed plans to de­vel­op a Covid-19 vac­cine. — Am­ber Tong

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

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Covid-19 roundup: Mer­ck pre­pares new study on their $425M Covid drug; CO­V­AX be­gins roll­out but huge dis­par­i­ties still loom

Merck spent $425 million to buy out OncoImmune in November, presumably under the belief that they could scale up their drug for severe Covid-19 and get it through the FDA on the strength of a Phase III trial the smaller biotech completed in September.

The FDA threw a wrench in those plans. The agency told Merck last week that the 203-person study wasn’t sufficient to show the drug was effective. Now, Bloomberg reports, Merck is preparing an additional Phase III study, one that will push results — and any chance of approval — back to the end of the year.