Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

More pro­gram cuts ahead as Sanofi CEO Paul Hud­son con­tin­ues to re­shape the com­pa­ny

One quar­ter in­to the new year, Sanofi CEO Paul Hud­son re­mains stead­fast on his mis­sion to re­shape the com­pa­ny — and that will mean some se­ri­ous pipeline prun­ing, par­tic­u­lar­ly in the gen­er­al med­i­cines unit.

Olivi­er Charmeil

In late 2019 and ear­ly 2020, Sanofi’s gen­er­al med­i­cines unit boast­ed more than 350 prod­uct fam­i­lies, ac­cord­ing to Olivi­er Charmeil, EVP of gen­er­al med­i­cines. By the end of this year, the com­pa­ny aims to re­duce that fig­ure to about 125, ei­ther by di­vest­ing or dis­con­tin­u­ing pro­grams. And by 2025, the goal is to sit at right around 100 prod­uct fam­i­lies.

“I think the team­work that’s go­ing on be­tween the busi­ness unit heads…  is re­al­ly im­por­tant to give us the op­por­tu­ni­ty to re­de­ploy re­source ei­ther to the bot­tom line or in­to R&D, and I think we’re re­al­ly get­ting in­to a good ca­dence on that,” Hud­son said on the call.

That prun­ing will ap­par­ent­ly start with four in­ves­ti­ga­tion­al HSV 2 vac­cines for adults with re­cur­rent gen­i­tal her­pes. Sanofi re­vealed in its Q1 news re­lease that it’s dis­con­tin­u­ing a Phase I study test­ing the four vac­cines for safe­ty and ef­fi­ca­cy, with­out of­fer­ing much more de­tail.

All that flex­i­bil­i­ty should leave Sanofi open for some in­ter­est­ing R&D moves, Hud­son hint­ed, adding that he aims to trans­form the com­pa­ny’s on­col­o­gy and neu­rol­o­gy port­fo­lios in­to “in­dus­try-lead­ing pipelines.”

How­ev­er, when it comes to M&A, he said his strat­e­gy re­mains the same. While mak­ing it clear that Sanofi is look­ing to add to its pipeline, he said the com­pa­ny will re­main “dis­ci­plined.”

“It’s clear that some prices have fall­en, but it’s al­ways been for us about pick­ing the right tar­get and the right as­set. It’s nev­er been about size. It’s al­ways been about the right thing, and that hasn’t changed for us. I think that just stays busi­ness as usu­al,” he said. “If we see the right thing, we’ll move, that’s been the same since the very be­gin­ning, at least since I’ve been here.”

Hud­son was tapped to the helm in 2019 and has since been on a mis­sion to re­vive Sanofi’s rep­u­ta­tion as a leader in drug re­search. Noth­ing is off the ta­ble when it comes to re­struc­tur­ing the com­pa­ny, he said ear­li­er this year, adding that the team has al­ready come a long way.

The chief ex­ec­u­tive culled a hand­ful of pro­grams last year, he re­vealed in the Q4 re­port, in­clud­ing one eval­u­at­ing Sar­clisa in pa­tients await­ing kid­ney treat­ment, and an­oth­er for SAR445088, a com­ple­ment C1s in­hibitor, in im­mune throm­bo­cy­tope­nia (ITP).

Sar­clisa had strug­gled on the up­take, as the drug was first ap­proved about a week and a half be­fore the WHO de­clared a glob­al pan­dem­ic last year, lim­it­ing pa­tient ac­cess. Now, it’s dri­ving the phar­ma gi­ant’s growth in on­col­o­gy, rak­ing in €65 mil­lion (over $68 mil­lion), up from just €34 mil­lion (un­der $36 mil­lion) in the same pe­ri­od last year.

The com­pa­ny al­so re­vealed in its Q4 re­sults that it plans on shav­ing about 6,000 jobs in an ef­fort to be­come more “ag­ile.” Ex­ecs said at the time that they were aim­ing for a head­count of around 90,000 by the end of the year.

Bill Si­bold

Look­ing ahead, Dupix­ent will be a big part of Sanofi’s growth, ac­cord­ing to Bill Si­bold, EVP of spe­cial­ty care and pres­i­dent of Sanofi’s North Amer­i­ca op­er­a­tions. The megablock­buster — which tar­gets both IL-4 and IL-13 — earned €1.6 bil­lion (near­ly $1.7 bil­lion) last quar­ter, up 45.7%.

“We are still on­ly at the be­gin­ning of our jour­ney with ap­prox­i­mate­ly 8% mar­ket pen­e­tra­tion in adults,” Si­bold said on the call.

Thomas Tri­om­phe

Just in the last cou­ple of months, the drug has snagged pri­or­i­ty re­view in eosinophilic esophagi­tis (EoE) for pa­tients 12 and old­er, and mod­er­ate-to-se­vere atopic der­mati­tis in kids be­tween 6 months and 5 years old. Sanofi is al­so look­ing to ex­pand the la­bel in­to un­con­trolled pruri­go nodu­laris and chron­ic pru­ri­tus of un­known ori­gin.

The com­pa­ny’s al­so pre­dict­ing an­oth­er record sales year for its flu prod­ucts, de­spite an 18.2% de­cline in the first quar­ter, which vac­cine head Thomas Tri­om­phe said is “tra­di­tion­al­ly a low quar­ter for flu sales.”

Tri­om­phe al­so not­ed that the com­pa­ny is “all in and full speed” on mR­NA pro­grams, af­ter out­lin­ing plans last sum­mer to spend €400 mil­lion ($437 mil­lion) a year on its mR­NA ef­fort. Last month, Hud­son sketched out a $1 bil­lion-plus in­vest­ment for a new mR­NA cen­ter in France. And last year, the com­pa­ny laid out some pos­i­tive ear­ly re­sults for an mR­NA-based Covid vac­cine can­di­date.

Sanofi was one of the phar­ma com­pa­nies to get out ear­ly in the Covid-19 vac­cine race us­ing a more tra­di­tion­al ap­proach, but that de­railed when the com­pa­ny saw weak re­spons­es in old­er adults.

“While we may have been a lit­tle bit lat­er to the par­ty on mR­NA, cer­tain­ly we feel like we’ve caught right up and ac­tu­al­ly un­der­stand what it takes to go for­ward and dif­fer­en­ti­ate it,” Hud­son said. “I think we’re go­ing to pos­si­bly sur­prise every­body, which is al­ways a good thing.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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