Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Dis­cov­ery Life Sci­ences has ac­quired what claims to be the Mary­land-based host of the world’s largest he­pa­to­cyte in­ven­to­ry, known as IVAL, to help re­searchers se­lect more ef­fec­tive and safer drug can­di­dates in the fu­ture.

The com­bined com­pa­nies will now serve a wider range of drug re­search and de­vel­op­ment sci­en­tists, ac­cord­ing to Al­bert Li, who found­ed IVAL in 2004 and is set to join the Dis­cov­ery lead­er­ship team as the CSO of phar­ma­col­o­gy and tox­i­col­o­gy.

Al­bert Li

Li has spent his ca­reer with IVAL sup­port­ing the sub­mis­sions and ap­provals of sev­er­al break­through ther­a­pies, carv­ing out a spe­cial­ty in the iso­la­tion, cry­op­reser­va­tion, and cul­tur­ing of hu­man he­pa­to­cytes and the ap­pli­ca­tion of hu­man he­pa­to­cytes to eval­u­ate drug me­tab­o­lism, drug-drug in­ter­ac­tions, and drug tox­i­c­i­ty.

“I am grate­ful to my IVAL team mem­bers who have en­trust­ed me with their ca­reers and are in­stru­men­tal to our achieve­ments. I look for­ward to be part of the won­der­ful and tal­ent­ed DLS fam­i­ly,” Li said in a LinkedIn post.

The com­pa­nies did not of­fer a dol­lar fig­ure on the ac­qui­si­tion.

The ac­qui­si­tion is Dis­cov­ery’s ninth in less than four years. In May, it ac­quired Tar­gos Mol­e­c­u­lar Pathol­o­gy GmbH out of Ger­many, to up its glob­al tis­sue bio­mark­er ser­vices. Be­fore that, it picked up San­ta Bar­bara, CA-based Qual­Tek, an im­muno­his­to­chem­istry provider. In March 2020, it an­nounced a sig­nif­i­cant ex­pan­sion of its cell bi­ol­o­gy and im­munol­o­gy ser­vices lab­o­ra­to­ry to speed up the de­vel­op­ment of cell ther­a­pies and im­munother­a­pies. — Josh Sul­li­van

Nube­qa reach­es pri­ma­ry end­point in PhI­II tri­al on new in­di­ca­tion for prostate can­cer

Bay­er’s prostate can­cer drug Nube­qa reached its pri­ma­ry end­point in a Phase III tri­al on a type of prostate can­cer, the com­pa­ny an­nounced ear­ly this morn­ing.

The Phase III Arasens tri­al, in­ves­ti­gat­ing what is al­so known as daro­lu­tamide on metasta­t­ic hor­mone-sen­si­tive prostate can­cer (mH­SPC), showed that the drug in com­bi­na­tion with chemother­a­py do­c­etax­el and an­dro­gen de­pri­va­tion ther­a­py (ADT) sig­nif­i­cant­ly in­creased over­all sur­vival rate, com­pared to do­c­etax­el and ADT by them­selves.

Nube­qa is cur­rent­ly in­di­cat­ed for the treat­ment of pa­tients with non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (nm­CR­PC).

“We are es­pe­cial­ly grate­ful to the pa­tients and in­ves­ti­ga­tors for par­tic­i­pat­ing in this im­por­tant tri­al and look for­ward to pre­sent­ing the full re­sults at an up­com­ing meet­ing,” said Bay­er SVP and head phar­ma­ceu­ti­cal on­col­o­gy de­vel­op­ment Scott Fields.

In a state­ment, Bay­er said they plan to dis­cuss the da­ta from the tri­al with health au­thor­i­ties re­gard­ing the sub­mis­sion of Nube­qa for mar­ket­ing au­tho­riza­tion in this in­di­ca­tion. No time­line was giv­en. — Paul Schloess­er

BeiGene and part­ner get Syl­vant ap­proved for mul­ti­cen­tric Castle­man dis­ease (MCD) in Chi­na

BeiGene and col­lab­o­ra­tor EU­SA Phar­ma an­nounced last night that Chi­na’s NM­PA ap­proved mon­o­clon­al an­ti­body treat­ment Syl­vant to treat adult pa­tients with mul­ti­cen­tric Castle­man dis­ease (MCD) who are both HIV-neg­a­tive and neg­a­tive for her­pes — which is al­so known as id­io­path­ic MCD (iM­CD).

This fol­lows pre­vi­ous ap­proval in the US and the EU.

“To­day’s ap­proval pro­vides a new treat­ment for pa­tients in Chi­na with this rare sys­temic dis­or­der,” com­ment­ed Xi­aobin Wu, pres­i­dent, COO, and gen­er­al man­ag­er of Chi­na at BeiGene. “This ap­proval is our sec­ond prod­uct in our col­lab­o­ra­tion with EU­SA. We look for­ward to launch­ing sil­tux­imab in 2022 and to help­ing pa­tients with iM­CD in Chi­na.”

The ap­proval of sil­tux­imab for the treat­ment of iM­CD was sup­port­ed by clin­i­cal re­sults from a multi­na­tion­al, ran­dom­ized, dou­ble blind and place­bo-con­trolled Phase II tri­al con­duct­ed in 79 pa­tients from 19 coun­tries and re­gions. — Paul Schloess­er

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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FDA slams door to piv­otal tri­al for bub­ble boy dis­ease gene ther­a­py as Mus­tang Bio runs in­to an­oth­er hold

Mustang Bio is in familiar territory, but that isn’t a place it necessarily wants to be.

The FDA has placed a hold on Mustang Bio’s pivitol trial for its gene therapy to treat patients with bubble boy disease, citing issues surrounding chemistry, manufacturing and controls clearance. It’s the second hold due to CMC issues the company has received in roughly 18 months.

An investigational new drug application was submitted in December 2021. If granted an IND, a Phase II study will then assess safety, tolerability and efficacy of MB-207. If approved by the FDA, the therapy would one day be eligible for a rare pediatric disease voucher.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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