Paul Hudson, Sanofi CEO (Sipa via AP Images)

Sanofi con­tin­u­ing with API spin­off de­spite French on-shoring push, ten­sions with union — Reuters

The ques­tion of where and by whom drugs’ ac­tive in­gre­di­ents are man­u­fac­tured was a fair­ly niche is­sue back in Feb­ru­ary, when new Sanofi CEO Paul Hud­son first said he would spin off the French gi­ant’s ac­tive phar­ma­ceu­ti­cal in­gre­di­ent (API) busi­ness in­to its own pub­lic com­pa­ny as part of his strate­gic re­think of the long-la­bor­ing drug­mak­er.

He like­ly did not imag­ine that it would soon be­come a na­tion­al se­cu­ri­ty ques­tion for many coun­tries as a pan­dem­ic threat­ened glob­al sup­ply lines and a vac­cine arms race un­der­scored the ad­van­tage those with in-coun­try phar­ma­ceu­ti­cal man­u­fac­tur­ing ca­pac­i­ty had. Or that French Pres­i­dent Em­manuel Macron would stand in a teal face­mask at their own French fa­cil­i­ties and tell broad­cast­ers about the need to keep pro­duc­tion in France.

Still, Sanofi is sol­dier­ing on with the plan to spin out its API busi­ness, Reuters re­port­ed. The goal re­mains to re-fo­cus the com­pa­ny around its most prof­itable ar­eas, in­clud­ing de­vel­op­ment of vac­cines and drugs for rare dis­eases and can­cer.

“Sanofi re­mains com­mit­ted to ex­e­cut­ing our IPO on Eu­ronext Paris as planned. We are not re­view­ing any oth­er fi­nan­cial al­ter­na­tive op­tion,” a Sanofi spokesper­son said in an email to Reuters in a rare un­equiv­o­cal state­ment for a Big Phar­ma talk­ing about its plans.

The plan, Reuters re­port­ed, is to be­gin so­lic­it­ing in­di­vid­ual in­vestors in the fall and po­ten­tial­ly launch an IPO in 2021 — a year ear­li­er than they had ini­tial­ly in­di­cat­ed. They are al­ready re­port­ed­ly in dis­cus­sions with the state in­vest­ment bank Bpifrance. The spin­out val­ue could range to 1-2 bil­lion eu­ros, de­pend­ing on how much Sanofi plans to keep for it­self, and would be­come the sec­ond largest API pro­duc­er be­hind Switzer­land’s Lon­za.

The spin­out would not nec­es­sar­i­ly mean pro­duc­tion would move, though it would ex­pose it to the whims of share­hold­ers. Sanofi has said the new group will still be head­quar­tered in France, and that Sanofi will re­tain a stake in the busi­ness and be its biggest cus­tomer.

The move, though, will be com­pli­cat­ed not on­ly by in­ter­na­tion­al con­cerns but al­so by in­ter­nal ones. Ten­sions be­tween Sanofi and its work­ers’ union have been run­ning high since the com­pa­ny said last month they would lay off 1,680 Eu­ro­pean work­ers over the next year.

A source told Reuters that talks with the union would be­gin in Sep­tem­ber. “Shap­ing the fu­ture of the API will be one of the first pri­or­i­ties of the man­age­ment team af­ter the sum­mer break,” they said, “and every­one is well aware the dis­cus­sions with the em­ploy­ee rep­re­sen­ta­tives will be very chal­leng­ing.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Covid-19 roundup: BAR­DA qui­et­ly pulls plug on IL-6 drugs; BioN­Tech and Fo­s­un be­gin mR­NA tri­al

IL-6 inhibitors showed some early promise in potentially treating Covid-19 patients, but recent trial flops have dashed hopes. Now it appears BARDA has officially pulled the plug.

The HHS office’s website has quietly updated to reflect that it is “no longer supporting product development” for Covid-19 in both Actemra (tocilizumab) and Kevzara (sarilumab), dealing a blow to the Roche and Regeneron/Sanofi drugs. This all but assures that IL-6 drugs repurposed to treat Covid-19 are essentially dead in the water.

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CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Kiersten Stead, John Hamer (DCVC Bio)

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life sci­ence spear

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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Stephen Hahn, FDA commissioner (AP Images)

FDA touts ad­vanced man­u­fac­tur­ing to ad­dress Covid-19 short­falls

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the Covid-19 pandemic, Stephen Hahn, FDA commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website.

“The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures,” Hahn and Shah wrote. “The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.”

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

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