Christophe Weber, Takeda CEO (Miho Takahashi/The Yomiuri Shimbun via AP Images)

Take­da bumps En­tyvio peak sales, lays out dengue vac­cine plans and celi­ac pipeline in lat­est earn­ings call

Take­da pro­ject­ed op­ti­mism in Thurs­day’s first-half fis­cal earn­ings call across its port­fo­lio, an­nounc­ing a boost in peak sales es­ti­mates for its al­ready block­buster IBD med En­tyvio along with pos­i­tive news on its dengue vac­cine Qden­ga and celi­ac dis­ease pipeline. The pos­i­tive out­look punc­tu­at­ed over­all sales growth on first-half rev­enue of $13.6 bil­lion, up 5.5%.

CEO Christophe We­ber at­trib­uted the growth to strong sales led by En­tyvio (+17%), hered­i­tary an­gioede­ma drug Takhzy­ro (+31%) and plas­ma prod­uct HyQvia (+17%).

For En­tyvio, an­tic­i­pat­ing a sub­cu­ta­neous ap­proval on the hori­zon, Take­da upped peak an­nu­al sales for the drug to $7.5-$9 bil­lion, a jump up from pre­vi­ous pro­jec­tions of $5.5-$6.5 bil­lion. It pro­ject­ed $5.4 bil­lion in sales for the cur­rent fis­cal full year 2022 sales (end­ing March 2023) and said it’s on track to file for the sub­cu­ta­neous in­jectable ver­sion of the cur­rent­ly IV-on­ly drug by end of fis­cal year 2023 (end­ing March 2024).

Take­da re­ceived a CRL for sub­cu­ta­neous En­tyvio in 2019; how­ev­er, that was re­lat­ed to the de­sign and la­bel­ing of the de­vice and not prod­uct safe­ty or ef­fi­ca­cy da­ta, the phar­ma re­port­ed last year. Take­da is work­ing with the FDA on the new sub­mis­sion.

Ra­mona Se­queira

When asked about the range, Ra­mona Se­queira, Take­da’s pres­i­dent of the glob­al port­fo­lio di­vi­sion, said the low­er end of the new peak would re­flect a re­jec­tion of the sub­cu­ta­neous ver­sion — which Take­da does not ex­pect — but would rather ac­count more for com­pe­ti­tion in the space.

En­tyvio com­peti­tors in the crowd­ed mar­kets for ul­cer­a­tive col­i­tis and Crohn’s dis­ease in­clude J&J’s Janssen’s Ste­lara, Pfiz­er’s Xel­janz and Ab­b­Vie’s Hu­mi­ra, Rin­voq and Skyrizi, along with mul­ti­ple scle­ro­sis oral med Zeposia from Bris­tol My­ers Squibb get­ting a re­cent UC nod.

On the vac­cine busi­ness, Take­da tout­ed its Qden­ga dengue vac­cine prospects al­ready ap­proved in In­done­sia, re­cent­ly notch­ing a pos­i­tive CHMP rec­om­men­da­tion and ready for FDA fil­ing be­fore the end of its fis­cal 2022. With an 84% de­crease in hos­pi­tal­iza­tions and 61% re­duc­tion in symp­to­matic cas­es — plus no im­por­tant safe­ty risks over the four-and-a-half-year study — Take­da said it’s con­fi­dent in Qden­ga’s prospects. While Sanofi’s Deng­vax­ia is al­ready ap­proved, Qden­ga would be dif­fer­ent in that it does not re­quire a pre-vac­ci­na­tion blood test to de­ter­mine if a per­son has al­ready had the dis­ease.

Se­queira tack­led a Qden­ga pric­ing ques­tion, first point­ing out the glob­al prob­lem of dengue dis­ease which is en­dem­ic in 100 coun­tries, and said Take­da will roll out tiered pric­ing that will seg­ment mar­kets based on “health­care so­phis­ti­ca­tion.”

She de­murred on specifics, point­ing to a Dec. 15 in­vestor meet­ing where more of Take­da’s Qden­ga com­mer­cial plans will be dis­cussed.

Andy Plump

Re­gard­ing pipeline de­vel­op­ment, Take­da R&D chief Andy Plump high­light­ed its celi­ac dis­ease port­fo­lio and progress. It re­cent­ly inked a deal with Zedi­ra and Dr. Falk Phar­ma on a Phase II drug known as TAK-227. Zedi­ra and Dr. Falk are cur­rent­ly run­ning a 12-week Phase IIb study with celi­ac pa­tients who are al­ready on a gluten-free di­et, as a fol­low-up to the Phase IIa study chal­lenge study, Plump said.

Af­ter the Phase IIb is com­plete, Take­da will take over for the Phase III one-year study fol­low­ing new­ly re­leased FDA guide­lines for what would be need­ed for a celi­ac dis­ease drug ap­proval. There is cur­rent­ly no ap­proved drug ther­a­py for celi­ac dis­ease, al­though more than a dozen can­di­dates are in tri­als. This sum­mer, 9 Me­ters dis­con­tin­ued its can­di­date lara­zotide, which was the on­ly Phase III drug un­der study.

Plump said, “We’ll need both his­to­log­i­cal and pa­tient-re­port­ed out­comes, both of which we’ve seen ben­e­fits on in our Phase IIa study.”

Oth­er Take­da celi­ac pro­grams in­clude TAK-062, a short-act­ing oral for po­ten­tial meal­time dos­ing, and TAK-101, a sys­temic im­mune-mod­i­fy­ing nanopar­ti­cle can­di­date.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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