Serge Weinberg, Sanofi (Tristan Reynaud, SIPA via AP Images)

Serge Wein­berg is­sues sharp re­ver­sal as board, French gov­ern­ment re­act to CEO Paul Hud­son’s vac­cine re­marks

Sanofi chair Serge Wein­berg on Thurs­day walked back en­tire­ly his CEO Paul Hud­son’s re­marks that the US would have “the right to the largest pre-or­der” of the French drug­mak­er’s Covid-19 vac­cine, should it be com­plete.

“There will be no par­tic­u­lar ad­vance giv­en to any coun­try,” Wein­berg told France 2 tele­vi­sion, ac­cord­ing to Reuters. “The com­ments of our CEO have been al­tered. We con­sid­er vac­cines as a com­mon good.”

Paul Hud­son

Wein­berg’s com­ments joined a cho­rus among the board and the French gov­ern­ment over the com­ments made Wednes­day by Hud­son, who in­sists he was mis­un­der­stood and had been call­ing on­ly for Eu­rope to take stronger ac­tion to sup­port the de­vel­op­ment of a vac­cine.

Re­mark­ing that a vac­cine should be for the “pub­lic good” and that Hud­son’s com­ments “af­fect­ed” French Pres­i­dent Em­manuel Macron, a gov­ern­ment of­fi­cial told Bloomberg Hud­son and oth­er Sanofi lead­er­ship were called to the pres­i­den­tial res­i­dence at the Él­y­seé Palace for a meet­ing. Ear­li­er Thurs­day morn­ing, when news of  Macron’s dis­sat­is­fac­tion first sur­faced, Hud­son said in an in­ter­view for the Fi­nan­cial Times‘ Glob­al Board­room that it was “news to him” that the pres­i­dent want­ed a meet­ing.

French Prime Min­is­ter Édouard Philippe al­so spoke out, say­ing on Twit­ter that “a vac­cine against Covid-19 should be a pub­lic good for the world.”

Af­ter the com­pa­ny is­sued an ini­tial state­ment walk­ing back Hud­son’s com­ments on Wednes­day — say­ing that US pro­duc­tion will be main­ly for the US and ex-US pro­duc­tion for Eu­rope and the globe — Wein­berg and oth­er mem­bers of Sanofi’s board spoke out out in greater force on Thurs­day.

Olivi­er Bogillot

Olivi­er Bogillot, chair­man of Sanofi’s French unit, ap­peared on BFM Tele­vi­sion and said there was no ques­tion about what would hap­pen.

“Ob­vi­ous­ly, if Sanofi makes a break­through on a vac­cine for Covid-19 and it is ef­fec­tive, it will be made avail­able to all,” he said.

Hud­son, ap­pear­ing for a sched­uled in­ter­view at the FT vir­tu­al con­fer­ence, tried to clar­i­fy his re­marks. The still rel­a­tive­ly new CEO had told Bloomberg that the US would get the largest pre-or­der be­cause the US bio-de­fense agency BAR­DA had fi­nanced their Covid-19 ef­fort, back­ing it with a $30 mil­lion grant this year. He urged Eu­rope to make a sim­i­lar ef­fort so coun­tries on the con­ti­nent “don’t get left be­hind.”

“What I’m try­ing to say every­where I go is that the US has BAR­DA, which is like a bi­o­log­i­cal re­search group that gets ahead of these things ear­li­er to get peo­ple ready and to try to make sure the nec­es­sary ca­pac­i­ty is built and the risks are shared,” he said.  “My com­ments are re­al­ly around what do we need to do to make sure we’re in a sim­i­lar po­si­tion in Eu­rope. It was nev­er a choice. We need to get vac­cines to every­body.”

Ex­perts warn, though, that when Covid-19 vac­cines do ar­rive, they will come in batch­es, forc­ing po­ten­tial­ly dif­fi­cult de­ci­sions about who gets the first dos­es. As­traZeneca CEO Pas­cal So­ri­ot said last month that the UK would get ear­ly ac­cess to the vac­cine they are pro­duc­ing with Ox­ford Uni­ver­si­ty.

Oust­ed BAR­DA chief Rick Bright said at a whistle­blow­er hear­ing Thurs­day that the US has a “place­hold­er” to or­der dos­es from some of the vac­cine com­pa­nies it fund­ed. The agency has put around $1 bil­lion to back J&J and Mod­er­na’s ef­forts. In ad­di­tion to the $30 mil­lion this spring, the agency has giv­en Sanofi and its re­com­bi­nant vac­cine sub­sidiary Pro­tein Sci­ences hun­dreds of mil­lions in grants over the last 15 years.

“The Unit­ed States has a place­hold­er with some of those com­pa­nies to be able to place or­ders for those vac­cines when they are avail­able,” Bright said. “And we did every­thing pos­si­ble to en­sure that those in­vest­ments were in com­pa­nies that would build ca­pac­i­ty in the Unit­ed States to man­u­fac­ture those vac­cines. We had to get in line first.”

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

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Andrew Cuomo, AP

Covid-19 roundup: Con­va­les­cent plas­ma flops in UK tri­al; New York Gov. An­drew Cuo­mo seeks to pur­chase vac­cines di­rect­ly from Pfiz­er

The UK’s RECOVERY trial is no longer recruiting patients for the convalescent plasma arm after an independent data monitoring committee found no significant improvement in mortality — another nail in the coffin for President Donald Trump’s so-called “historic breakthrough” treatment.

The RECOVERY trial spans several potential Covid-19 treatments, including  Regeneron’s antibody cocktail, and the anti-inflammatories colchicine and tocilizumab. But convalescent plasma missed its primary endpoint in a preliminary analysis, and the DMC “saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup,” according to a report by the trial’s co-chairs, Peter Horby and Martin Landray.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

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Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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News brief­ing: Beam bags a $260M pri­vate place­ment; mi­Ra­gen re­brands to Virid­i­an Ther­a­peu­tics

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.