Rick Gonzalez, CEO of AbbVie (AP Images)

Ab­b­Vie's Gon­za­lez: Skyrizi and Rin­voq to be­come Hu­mi­ra 2.0 — while adding an in­di­ca­tion for atopic der­mati­tis

While Ab­b­Vie’s Hu­mi­ra still holds the crown for the best-sell­ing non-Covid drug last year, the Big Phar­ma has its eyes on Hu­mi­ra’s po­ten­tial suc­ces­sor. Scratch that, suc­ces­sors.

Ab­b­Vie CEO Rick Gon­za­lez told in­vestors and an­a­lysts on the phar­ma’s Q4 call this morn­ing that Ab­b­Vie ex­pects to add sev­er­al new in­di­ca­tions to Skyrizi and Rin­voq’s “list of ap­proved us­es” over the next few months. For Skyrizi, they got the FDA’s OK a few weeks ago to use the drug for pso­ri­at­ic arthri­tis — and they’re al­so look­ing for the thumbs up from the agency on Crohn’s dis­ease.

Af­ter that’s done, “Skyrizi and Rin­voq will be com­mer­cial­ized across all of Hu­mi­ra’s ma­jor in­di­ca­tions — plus atopic der­mati­tis,” Gon­za­lez said. To fur­ther dri­ve that point home, Gon­za­lez added a clinch­er: “We ex­pect com­bined peak sales for Skyrizi and Rin­voq to ex­ceed the peak rev­enues achieved by Hu­mi­ra.”

While he didn’t give an ex­act time­line for when the phar­ma ex­pects that to hap­pen, that’s big news — we saw Ab­b­Vie piv­ot funds from mar­ket­ing Hu­mi­ra to those sib­ling drugs ear­li­er last year, and the two drugs had com­bined sales of just around $4.6 bil­lion in 2021. While the com­pa­ny claims “sub­stan­tial growth” in sales num­bers for the drugs next year, it has a long way to go to catch up to Hu­mi­ra, which has had some in­sane­ly high sales num­bers over the last few years.

Hu­mi­ra crossed the $20 bil­lion dol­lar mark in sales last year, end­ing up at $20.7 bil­lion af­ter post­ing $5.3 bil­lion in sales last quar­ter. Eval­u­ate Van­tage pre­dict­ed last year that Hu­mi­ra would go past the $20 bil­lion dol­lar mark in 2022 sales, land­ing at an es­ti­mat­ed $20.4 bil­lion.

This year might be Hu­mi­ra’s last big one, as Hu­mi­ra starts to lose ex­clu­siv­i­ty rights in 2023, which opens the door to com­peti­tors and Hu­mi­ra los­ing mar­ket share.

Gon­za­lez told an­a­lysts that the phar­ma will have earn­ings guid­ance ready for Hu­mi­ra in Q3 af­ter get­ting a bet­ter idea for the “ero­sion curve” that loss of mar­ket ex­clu­siv­i­ty will bring the megablock­buster. How­ev­er, he said at the mo­ment, peo­ple should be ex­pect­ing 45% ero­sion, plus or mi­nus 10%. And then ex­pect fur­ther de­cline in­to 2024.

In oth­er news, the phar­ma al­so an­nounced its rev­enue for 2021: $56 bil­lion. And just a few hours af­ter the Q4 call, the FDA an­nounced that it ap­proved a gener­ic from Vi­a­tris for resta­sis eye drops, a treat­ment for dry eye dis­ease that is made by now-Ab­b­Vie sub­sidiary Al­ler­gan. Ab­b­Vie bought out the com­pa­ny back in 2020 for $63 bil­lion.

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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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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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.

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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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.

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.

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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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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