Paul Hudson, Sanofi CEO (Photographer: Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

Sanofi chief ex­ec­u­tive Paul Hud­son told in­vestors ear­li­er this year that the Big Phar­ma was go­ing to em­pha­size its sales king­pin Dupix­ent mov­ing for­ward.

He wasn’t jok­ing — the megablock­buster drug and sales king, record­ing just shy of $2 bil­lion in sales this past quar­ter, has now of­fi­cial­ly se­cured its fifth in­di­ca­tion from the FDA.

Sanofi and Re­gen­eron, who joint­ly work on Dupix­ent de­vel­op­ment and com­mer­cial­iza­tion, an­nounced the new de­vel­op­ment on Thurs­day, say­ing that the FDA gave the all-clear to Dupix­ent to treat pa­tients with pruri­go nodu­laris, a rare au­toim­mune dis­or­der char­ac­ter­ized by a per­sis­tent, se­vere itch — and al­so vi­su­al­ized by hard, ex­treme­ly itchy bumps known as nod­ules that form on the skin. The FDA not­ed in its an­nounce­ment that it is the agency’s first ap­proval for the dis­ease.

Sanofi not­ed in a state­ment that the fed­er­al reg­u­la­to­ry agency green­lit the ap­proval un­der pri­or­i­ty re­view af­ter the com­pa­nies sub­mit­ted da­ta from two piv­otal tri­als, which were di­rect-to-Phase III.

The first tri­al, which read out in Oc­to­ber last year, showed that 37% of the 78 pa­tients on Dupix­ent showed a “clin­i­cal­ly mean­ing­ful re­duc­tion in itch from base­line,” com­par­ing that to on­ly 22% of pa­tients on place­bo af­ter 12 weeks. With a p-val­ue of p=0.0216, it met the pri­ma­ry end­point.

The ben­e­fits got bet­ter af­ter an­oth­er 12 weeks — 58% of those on Dupix­ent reached the pri­ma­ry end­point af­ter 24 weeks, while on­ly 20% of those reached the pri­ma­ry end­point on place­bo. That clocked in at a p-val­ue of p<0.0001.

Naimish Pa­tel

The sec­ond tri­al, with re­sults three months lat­er, es­sen­tial­ly ver­i­fied the 24-week da­ta from the first study. 60% of Dupix­ent pa­tients saw the “clin­i­cal­ly mean­ing­ful re­duc­tion in itch from base­line” — com­pared to on­ly 18% of those on place­bo, al­so clock­ing in a p-val­ue of p<0.0001 for sta­tis­ti­cal sig­nif­i­cance.

Sanofi’s R&D im­munol­o­gy chief Naimish Pa­tel tells End­points News that Sanofi start­ed look­ing in­to the in­di­ca­tion af­ter sev­er­al col­lab­o­ra­tors and key ex­perts had a hy­poth­e­sis about type II in­flam­ma­tion, caused by IL-4 and IL-13, and its role in the dis­ease. Af­ter look­ing at re­al-world ev­i­dence and oth­er case se­ries, Pa­tel said that there was sup­port that Dupix­ent in pruri­go nodu­laris just might work — and so the com­pa­ny de­cid­ed to go straight to Phase III.

As for what’s next, here’s what Pa­tel said:

We’re go­ing to go to Eu­rope and oth­er mar­kets. We don’t have ap­proval yet, but that’s some­thing in the works al­ready.

The ex­act time­line for that, though, is still un­clear.

This new in­di­ca­tion adds to asth­ma, atopic der­mati­tis, eosinophilic esophagi­tis and chron­ic rhi­nos­i­nusi­tis with nasal poly­po­sis — and Sanofi has ad­di­tion­al in­di­ca­tions in its pipeline for the drug, in­clud­ing chron­ic pru­ri­tus of un­known ori­gin, which Pa­tel said is in the mid­dle of a di­rect-to-Phase III tri­al.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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