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

Bioreg­num
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

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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James Sabry

'We're in': Roche and Genen­tech join forces on a multi­bil­lion-dol­lar dis­cov­ery pact with a brash AI up­start

Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.