Ab­b­Vie’s promised rheuma­toid arthri­tis block­buster upadac­i­tinib hits its marks in an­oth­er PhI­II — this time with­out any deaths

Ab­b­Vie $AB­BV has post­ed an­oth­er pos­i­tive batch of Phase III da­ta on its JAK1 in­hibitor upadac­i­tinib, hit­ting the pri­ma­ry and key sec­ondary end­points in their piv­otal pro­gram for rheuma­toid arthri­tis. And this round of da­ta comes with­out any new deaths in the drug arm to rat­tle in­vestors and an­a­lysts.

Their drug — for­mer­ly ABT-494 — hand­i­ly outscored a place­bo, which was not un­ex­pect­ed. The ther­a­py bare­ly edged out Hu­mi­ra on ACR 20 at 12 weeks, but did much bet­ter on a range of end­points like ACR50 (45% ver­sus 29%) and clin­i­cal re­mis­sion rates (29% ver­sus 18%). On­ly 6% of the place­bo arm ex­pe­ri­enced clin­i­cal re­mis­sion.

Ab­b­Vie has been spot­light­ing this JAK1 pro­gram as one of its two top late-stage drug can­di­dates with a mega-block­buster fu­ture ahead for it. While their cash cow Hu­mi­ra has been freed of the threat of biosim­i­lar com­pe­ti­tion to 2023, ri­vals are muscling in on its ter­ri­to­ry. The on­ly way Ab­b­Vie achieves big­ger rev­enue on Hu­mi­ra each year is by in­creas­ing its price.

An­a­lysts fol­low­ing the drug breathed an au­di­ble sigh of re­lief at this lat­est post. Ge­of­frey Porges not­ed:

The to­tal clin­i­cal ex­pe­ri­ence of upadac­i­tinib has now in­creased sub­stan­tial­ly with­out demon­strat­ing a ma­jor risk for VTEs, which we be­lieve re­duces the risk of un­ex­pect­ed as­set fail­ure. Af­ter the re­cent fail­ure of Ro­va-T in third-line small cell lung can­cer, and the re­lat­ed drop in Ab­b­Vie’s stock val­ue of >20%, the risk of a sub­se­quent pipeline fail­ure now al­so ap­pears sub­stan­tial­ly re­duced.

It’s a busy field. A Sanofi/Re­gen­eron team won an ap­proval for their IL-6 drug sar­ilum­ab (Kevzara) last year, as Gilead push­es ahead on their JAK1 fil­go­tinib af­ter Ab­b­Vie aban­doned it in fa­vor of its in-house pro­gram for upadac­i­tinib. Eli Lil­ly is back up for a re­view of baric­i­tinib, mean­while, af­ter the FDA re­versed a de­ci­sion to re­ject the drug with­out more da­ta. But J&J was per­ma­nent­ly shunt­ed aside re­cent­ly af­ter the FDA spurned its ap­pli­ca­tion on sirukum­ab.

If it can gain a new ap­proval on this drug, Ab­b­Vie ex­ecs are promis­ing peak sales in the range of $6.5 bil­lion a year, even though it faces plen­ty of com­pe­ti­tion.

Ab­b­Vie star­tled in­vestors with news of the death of two pa­tients in one study. And more re­cent­ly in­ves­ti­ga­tors had to ex­plain that an­oth­er pa­tient in the low-dose arm died of a he­m­or­rhag­ic stroke caused by a rup­tured aneurysm while there was al­so a case of pul­monary em­bolism in the same group. That fol­lowed a re­port in Sep­tem­ber that a pa­tient tak­ing a 30 mg dose ex­pe­ri­enced heart fail­ure and pre­sumed pul­monary em­bolism. In the most re­cent cas­es, both pa­tients had al­ready ex­hib­it­ed risks for these con­di­tions, ac­cord­ing to Ab­b­Vie.

Ab­b­Vie has al­so been ham­mered for some as­ton­ish­ing­ly bad da­ta on Ro­va-T, a can­cer drug it ac­quired in a jaw-drop­ping, $10.2 bil­lion buy­out deal for Stem­cen­trx two years ago.

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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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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Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)

Fourth ac­cel­er­at­ed ap­proval in Duchenne? Sarep­ta gets pri­or­i­ty re­view for gene ther­a­py amid FDA scruti­ny

Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.

The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.

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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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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.