Sanofi is jet­ti­son­ing its in­fec­tious dis­ease unit to Evotec — hand­ing over cash, staff and a pipeline

Sanofi is spin­ning out its in­fec­tious dis­ease re­search unit to Evotec, the Ger­man con­tract de­vel­op­ment or­ga­ni­za­tion known for its deal savvi­ness. And the Paris-based phar­ma gi­ant $SNY — suf­fer­ing from a long drought that has blight­ed its in­ter­nal R&D ops — is hand­ing over €60 mil­lion (around $74 mil­lion) up­front for the op­er­a­tion along with con­tin­ued fi­nanc­ing, 10 ex­per­i­men­tal in­fec­tious dis­ease projects and 100 of its staffers to get it all go­ing.

Wern­er Lan­thaler

A new in­no­va­tion plat­form will open near Ly­on, France. Evotec will run the place, but the phar­ma part­ner re­tains op­tions to de­vel­op and com­mer­cial­ize any po­ten­tial prod­uct can­di­dates. Sanofi’s big vac­cine unit, how­ev­er, is stay­ing strict­ly out of it.

Any or­ga­ni­za­tion in­ter­est­ed in in­fec­tious dis­ease drug de­vel­op­ment, rang­ing from acad­e­mia, biotech/phar­ma com­pa­nies, foun­da­tions to gov­ern­ment agen­cies, are wel­come to col­lab­o­rate.

“Find­ing a way to mo­ti­vate more pub­lic fund­ing and aca­d­e­m­ic ini­tia­tives for the progress of nov­el an­ti-in­fec­tives on Evotecs’ plat­form will be a key suc­cess fac­tor for this ini­tia­tive,” said Evotec CEO Wern­er Lan­thaler in a state­ment.

Elias Zer­houni

Evotec is al­so bring­ing its own team to the Ly­on plat­form. More than 150 of its sci­en­tists will be ac­tive in this ex­pand­ed drug dis­cov­ery and de­vel­op­ment ef­fort. An­ti-in­fec­tives are one of five core ther­a­peu­tic ar­eas Evotec lists as its main ex­per­tise, hav­ing ac­quired in­fec­tious dis­ease spe­cial­ist CRO Eu­pro­tec back in 2014.

Un­der the agree­ment, which is ex­pect­ed to com­plete in a few months, Sanofi will pro­vide “sig­nif­i­cant fur­ther long-term fund­ing” to sup­port the growth of the port­fo­lio, though num­bers were not spec­i­fied.

These kinds of job swap­ping events aren’t all that un­usu­al in bio­phar­ma. GSK trans­ferred a large group of staffers to a CRO when it re­or­ga­nized its re­search group in North Car­oli­na — which sub­se­quent­ly laid off em­ploy­ees. Take­da has been do­ing the same thing while As­traZeneca and oth­ers have spun out com­pa­nies and drugs to star­tups as they re­vamped and re­fo­cused in­ter­nal op­er­a­tions.

Sanofi tried to down­size its French R&D op­er­a­tions un­der for­mer CEO Chris Viehbach­er, but the unions al­lied with gov­ern­ment of­fi­cials man­aged to pre­vent much of the re­struc­tur­ing that was planned. This time, Sanofi isn’t even hint­ing at lay­offs, not­ing that they are pro­vid­ing all de­part­ing staffers with 5-year em­ploy­ment con­tracts.

It’s no co­in­ci­dence that Sanofi al­so closed on its $11.6 bil­lion deal to ac­quire Biover­a­tiv to­day. The buy­out gives Sanofi rev­enue from ex­ist­ing he­mo­phil­ia drugs, and a pipeline of new ther­a­pies to con­tend with. That deal vir­tu­al­ly co­in­cid­ed with a pact to ac­quire Abl­ynx and its an­ti­body plat­form, fi­nal­ly de­liv­er­ing on a longterm promise to buy in new as­sets.

R&D chief Elias Zer­houni said the deal doesn’t mean that Sanofi is giv­ing up on in­fec­tious dis­ease:

Sanofi has a long and es­tab­lished his­to­ry in the fight against in­fec­tious dis­eases, and we re­main com­mit­ted to ad­dress­ing glob­al health chal­lenges through our de­vel­op­ment ef­forts and vac­cines. Re­search in the field of an­ti-in­fec­tives is an area where build­ing crit­i­cal mass through part­ner­ing is par­tic­u­lar­ly im­por­tant. This new French based open in­no­va­tion cen­ter will ben­e­fit from the high qual­i­ty sci­ence ecosys­tem.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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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.

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, and could help shore up public trust in the agency and any eventual vaccine.

Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the biotech.

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News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.

Rep. Andy Harris (R-MD) (Tasos Katopodis/Pool via AP Images)

The mi­cro-cap that tapped a mask-skep­tic con­gress­man for their Covid DSMB is ap­ply­ing for an EUA. Their ev­i­dence? 21 pa­tients

NeuroRx, the tiny biotech that came under fire last week after Politico reported they selected a congressman and two other acquaintances of the CEO to supervise their Covid-19 drug trial, announced today that they will ask the FDA to authorize their drug based on the results of just 21 patients.

Such an application would test the agency’s standards of evidence for an EUA, which have already come under scrutiny after controversial authorizations for convalescent plasma and hydroxychloroquine. The only other company to discuss their intention to file for an EUA, Eli Lilly, did so after results came back from a randomized control study testing their antibody in over 450 patients.

J&J re­leas­es PhI­II safe­ty blue­print for Covid-19 vac­cine tri­al. How does it stack up to Mod­er­na, Pfiz­er and As­traZeneca?

Along with the initiation of its Phase III Covid-19 vaccine study announced Wednesday morning, Johnson & Johnson also released its trial protocol, giving an inside look at how the company is conducting its late-stage research.

The move comes after the other three companies conducting Phase III’s in the US — Moderna, Pfizer and AstraZeneca — each disclosed their own trial blueprints within the last week. Though the release of such protocols is typically done after trials have been completed, drug developers had come under intense pressure after a brief safety scare in an AstraZeneca trial and amid growing concern of a politically motivated vaccine authorization.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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