Sanofi's R&D day pos­es some big chal­lenges as skep­tics cir­cle in wake of a Deng­vax­ia fi­as­co

The view from John Car­roll

To­mor­row the an­a­lysts that cov­er Sanofi $SNY will gath­er in Paris to hear the phar­ma gi­ant out­line its R&D strat­e­gy. And more than a few skep­tics from the in­vestor com­mu­ni­ty will be on hand.

Af­ter re­ly­ing on part­ners like Re­gen­eron $REGN and Al­ny­lam $AL­NY to de­liv­er the goods on in­no­va­tion and sig­nif­i­cant new progress in drug de­vel­op­ment, chief sci­en­tist Elias Zer­houni be­lieves it’s time to be­come more self-re­liant.

But that’s go­ing to be a very hard sale.

In­ter­nal­ly, the R&D or­ga­ni­za­tion has been one of the most no­to­ri­ous lag­gards in Big Phar­ma, ri­val­ing GSK in un­der­per­for­mance. Its one big suc­cess, the dengue vac­cine Deng­vax­ia, has now im­plod­ed as the Philip­pine gov­ern­ment claims it was bam­boo­zled in­to vac­ci­nat­ing hun­dreds of thou­sands of chil­dren with a vac­cine that threat­ens pre­vi­ous­ly un­ex­posed sub­jects with se­vere cas­es of dengue — per­haps he­m­or­rhag­ic fever.

Now the Philip­pines wants its mon­ey back. And a prod­uct that was held up as an ex­am­ple of Sanofi’s abil­i­ty to de­vel­op block­busters has be­come a li­a­bil­i­ty of un­known pro­por­tions.

To top it off, Sanofi just days ago said it will ter­mi­nate its late-stage pro­gram for a Clostrid­i­um dif­fi­cile vac­cine af­ter in­ves­ti­ga­tors de­ter­mined they were on a straight path to fail­ure.

Ru­di Van Den Eyn­de

In the mean­time, Sanofi tried and failed to de­liv­er on some sig­nif­i­cant buy­outs, out­bid by Pfiz­er for Medi­va­tion (and like­ly glad of that) and rais­ing doubts that it knows how to buy a com­pa­ny af­ter watch­ing Acte­lion go to J&J.

“Noth­ing is hap­pen­ing in terms of busi­ness de­vel­op­ment and there is very lit­tle news in the pipeline. What just hap­pened with dengue is neg­a­tive and shock­ing,” Can­dri­am’s Ru­di Van Den Eyn­de told Reuters in a bleak as­sess­ment of the com­pa­ny’s per­for­mance.

Af­ter tak­ing a stab at can­cer, the phar­ma gi­ant end­ed up re­struc­tur­ing that ef­fort af­ter some key set­backs. That in­cludes fe­dra­tinib, which was re­cent­ly hand­ed back to one of the sci­en­tists who helped dis­cov­er it and is now tak­ing it back in­to late-stage de­vel­op­ment. And now Sanofi’s in-house pipeline is lim­it­ed to a few key ef­forts, in­clud­ing isat­ux­imab (SAR650984), an un­con­ju­gat­ed an­ti-CD38 an­ti­body in Phase III de­vel­op­ment for re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma.

A cou­ple of years ago I sat down with Zer­houni and he told me that a com­pa­ny like Sanofi has no busi­ness buy­ing plat­form R&D ef­forts. They’d just kill it, he says, which is why he in­sist­ed to the board long ago that buy­ing Re­gen­eron was a ter­ri­ble idea.

Chris Viehbach­er

It hasn’t al­ways been a smooth path, but Sanofi now has sev­er­al part­ner­ships de­liv­er­ing on in­no­va­tion. Its rep­u­ta­tion in-house couldn’t be worse, es­pe­cial­ly af­ter for­mer CEO Chris Viehbach­er tried and failed to kick off a ma­jor re­or­ga­ni­za­tion in France af­ter the Gen­zyme ac­qui­si­tion.

Zer­houni, though, has been telling an­a­lysts that the phar­ma gi­ant’s in-house bi­o­log­ics and an­ti­body work has pro­gressed to the point that it doesn’t need Re­gen­eron for that, shift­ing to a con­cen­tra­tion on their part­ner­ship for the world’s sixth PD-1/L1 drug, due to be filed in a mat­ter of weeks or months.

With their di­a­betes fran­chise un­der the gun, Sanofi con­tin­ues to scout for ma­jor ac­qui­si­tions of the $20 bil­lion to $30 bil­lion cat­e­go­ry. In­vestors have been clam­or­ing for M&A for years, but the com­pa­ny’s ex­ec­u­tive team re­fus­es to be rushed.

Im­age: Sanofi chief sci­en­tist Elias Zer­houni

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.