Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In re­sponse to a ques­tion on man­u­fac­tur­ing scale at Leg­end Biotech’s R&D day yes­ter­day, the com­pa­ny’s top ex­ec said its part­ner­ship with John­son & John­son will be dou­bling its in­vest­ment in its New Jer­sey man­u­fac­tur­ing cen­ter and will be in­vest­ing a to­tal of $500 mil­lion.

With an eye on their BC­MA-di­rect­ed CAR-T ther­a­py Carvyk­ti (cil­ta-cel), ap­proved in Feb­ru­ary as a fifth-line treat­ment for mul­ti­ple myelo­ma, Leg­end CEO Ying Huang said that the ramp-up in pro­duc­tion and the de­ci­sion to man­u­fac­ture its own lentivi­ral vec­tors — cur­rent­ly in short­age world­wide — means they won’t have to deal with that short­age.

“So far, Leg­end and Janssen have in­vest­ed $250 mil­lion in Rar­i­tan [New Jer­sey] and we will in­vest an­oth­er $250 mil­lion joint­ly,” a Leg­end spokesper­son added via email. “The sec­ond $250 mil­lion will be spent over the next 2-3 years to ex­pand the build­out of our New Jer­sey site to sup­port peak ca­pac­i­ty.”

The build­out is part of ef­forts to put the com­pa­nies in po­si­tion to ac­com­mo­date for $5 bil­lion-plus in peak pro­ject­ed sales for Carvyk­ti.

Huang said ear­li­er this year that the es­ti­mate, which is con­sid­er­ably high­er than Bris­tol My­ers Squibb’s es­ti­mate of $1 bil­lion for peak Abec­ma sales, is due to the ther­a­py’s po­ten­tial to reach ear­li­er lines of treat­ment.

SVB Se­cu­ri­ties an­a­lysts on Tues­day called the $500 mil­lion an­nounce­ment “the ex­treme side of cGMP fa­cil­i­ty ex­pens­es,” not­ing that the ex­pan­sion will help them

reach scale for their ear­li­er line tri­als, cit­ing an­tic­i­pat­ed ap­proval for cil­ta-cel in the 2L+ set­ting (based on CAR­TI­TUDE-4) as the pro­posed dead­line for the build-out. With this build-out, Leg­end plans to dou­ble their ap­proved treat­ment cen­ters to 70-80 cen­ters.

Carvyk­ti stole the show at AS­CO 2017 when Leg­end CSO Frank Fan and his team re­port­ed an im­pres­sive 100% over­all re­sponse rate among mul­ti­ple myelo­ma pa­tients. That was enough for Janssen to jump in with a $350 mil­lion cash deal to part­ner on the big can­cer can­di­date.

SVB Se­cu­ri­ties added, while es­ti­mat­ing a launch date for BMS and 2sev­en­ty’s Abec­ma (ide-cel) in third to fifth line mul­ti­ple myelo­ma in the first half of 2023, on the man­u­fac­tur­ing front:

Nei­ther 2sev­en­ty / BMY or Leg­end / JNJ have guid­ed COGS ex­pec­ta­tions for BC­MA CAR-T in the long term. 2sev­en­ty man­age­ment has guid­ed that ide-cel will be prof­itable to­wards the end of 2022 or ear­ly 2023, as they scale more dos­es on the base in­fra­struc­ture. We as­sume pro­gram prof­itabil­i­ty for ide-cel in 1Q23 and then COGS ramp-down, with in­creased ide-cel man­u­fac­tur­ing scale. For us, the speed and ex­tent of op­er­a­tional ef­fi­cien­cies are high­ly un­cer­tain.

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.

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.

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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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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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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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.