Trump, Big Phar­ma trade barbs over drug pric­ing EOs; BAR­DA gives Re­gen­eron $350M for Ebo­la drugs

Ten­sions be­tween the White House and Big Phar­ma have ratch­eted up af­ter Pres­i­dent Don­ald Trump an­nounced four ex­ec­u­tive or­ders tar­get­ing the phar­ma­ceu­ti­cal in­dus­try. On Tues­day morn­ing, the pres­i­dent fired off the lat­est pub­lic sal­vo, while Pfiz­er CEO Al­bert Bourla harsh­ly crit­i­cized the di­rec­tives in a call with in­vestors.

With­out pro­vid­ing ev­i­dence, Trump on Twit­ter ac­cused phar­ma com­pa­nies of air­ing tele­vi­sion ads at­tack­ing him and, he says, false­ly claim the poli­cies would raise pre­scrip­tion drug prices for se­niors. It was not clear to which ad or ads Trump was re­fer­ring.

Al­bert Bourla

Short­ly there­after, Bourla said the pres­i­dent’s ac­tions would cause “enor­mous de­struc­tion” as the in­dus­try col­lec­tive­ly tries to re­search and de­vel­op vac­cines for Covid-19, ac­cord­ing to a CN­BC re­port. The com­ments took place dur­ing a con­fer­ence call dis­cussing the com­pa­ny’s sec­ond-quar­ter earn­ings.

“Over­all, I’m dis­ap­point­ed by this ex­ec­u­tive or­der,” Bourla re­port­ed­ly said on the call. “They pose enor­mous dis­trac­tion at a time where the in­dus­try needs to be com­plete­ly fo­cused on de­vel­op­ing a po­ten­tial COVID-19 vac­cine or treat­ment. The in­ter­na­tion­al price in­dex is rad­i­cal. Not on­ly it is im­pos­ing so­cial­ized med­i­cine to Amer­i­ca, it al­so will cre­ate un­cer­tain­ty and could lead to job loss­es.”

The broad­sides come a day af­ter POLITI­CO re­port­ed that phar­ma­ceu­ti­cal ex­ec­u­tives spurned the pres­i­dent’s in­vi­ta­tion to meet with him to dis­cuss the “most-fa­vored na­tions clause.” A pol­i­cy that has long been scorned by the in­dus­try, the clause would tie pre­scrip­tion drug prices in the Unit­ed States to what con­sumers pay abroad.

At his Fri­day press con­fer­ence, Trump threat­ened to en­act the or­der with­in 30 days if drug­mak­ers did not take ac­tion to low­er pre­scrip­tion prices on their own. Trump signed three oth­er ex­ec­u­tive or­ders Fri­day, each aimed at curb­ing pre­scrip­tion drug costs as the No­vem­ber elec­tion ap­proach­es. — Max Gel­man

Re­gen­eron gets near­ly $350 mil­lion Ebo­la BAR­DA con­tract

Re­gen­eron has re­ceived a new con­tract from BAR­DA, and it’s not for Covid-19.

The US biode­fense agency has agreed to pur­chase an undis­closed amount of REGN-EB3, Re­gen­eron’s Ebo­la an­ti­body cock­tail, over the next 6 years. The agree­ment will pay Re­gen­eron $10 mil­lion next year and ap­prox­i­mate­ly $67 mil­lion over each of the fol­low­ing 5 years.

REGN-EB3 is still await­ing FDA ap­proval — a PDU­FA date has been set, un­der pri­or­i­ty re­view, for Oc­to­ber 25 — but it has al­ready proven one of two ef­fec­tive treat­ments for the dead­ly virus. In a land­mark study com­plet­ed last year, it was one of two drugs that re­duced mor­tal­i­ty to around 30%, and served as a near-cure when giv­en ear­ly enough. The oth­er ef­fec­tive drug was a sin­gle an­ti­body de­vel­oped by the NIH, in col­lab­o­ra­tion with Hum­abs, which is now a sub­sidiary of Vir. That an­ti­body has since been li­censed to the Ridge­back Bio­ther­a­peu­tics, which re­cent­ly filed for FDA ap­proval.

Al­though not di­rect­ly tied to Covid-19, the agree­ment is part of a larg­er strat­e­gy to stock­pile drugs that could pre­pare the US for po­ten­tial out­breaks — a strat­e­gy al­ready de­ployed for an­thrax. Re­gen­eron’s Ebo­la pro­gram, de­vel­oped dur­ing the 2014-2016 West African cri­sis, was al­so con­duct­ed in part­ner­ship with BAR­DA, lay­ing the ground­work for the cur­rent $450 mil­lion Covid-19 col­lab­o­ra­tion. — Ja­son Mast

Eli Cas­din in­vests in French biotech de­vel­op­ing EDS tech­nol­o­gy

Eli Cas­din

Promi­nent biotech in­vestor Eli Cas­din has turned his sights on DNA Script, as Cas­din Cap­i­tal heads up an ex­tend­ed round of Se­ries B fund­ing for the French biotech.

DNA Script pulled in $50 mil­lion in new in­vest­ments, the com­pa­ny an­nounced Wednes­day, and Cas­din will join its board of di­rec­tors. The fund­ing ex­ten­sion brings DNA Script’s to­tal Se­ries B amount to $89 mil­lion.

Cas­din is the son of the pi­o­neer­ing biotech an­a­lyst Jef­frey Cas­din, who be­gan in­vest­ing in the field in the 1980s and soon be­came one of the field’s top Wall Street minds. Eli Cas­din and his broth­er Alexan­der worked at their fa­ther’s Coop­er Hill Part­ners be­fore it shut­tered in 2007, and Eli Cas­din found­ed Cas­din Cap­i­tal in 2012.

The life-sci­ences in­vest­ment firm has fund­ed many projects over the years, about 70 per­cent of which have been in drug de­vel­op­ment, Cas­din told End­points News last year. DNA Script, the lat­est to re­ceive Cas­din’s stamp of ap­proval, fo­cused on en­zy­mat­ic DNA syn­the­sis tech­nol­o­gy, and this round of fund­ing will go specif­i­cal­ly to­ward launch­ing the com­pa­ny’s DNA bench­top print­er.

In ad­di­tion to Cas­din Cap­i­tal, in­vestors in­clud­ed Mer­ck KgaA’s VC arm, Dana­her Life Sci­ences, Ag­i­lent Tech­nolo­gies, LSP, the Bpifrance Large Ven­ture Fund and Il­lu­mi­na Ven­tures. — Max Gel­man

AI-fo­cused Re­cur­sion Bio pur­chas­es Vi­um, ac­quir­ing pre­clin­i­cal da­ta col­lec­tion plat­form

Re­cur­sion Bio, a com­pa­ny that billed it­self as the first AI biotech to put on hu­man tri­als, an­nounced the ac­qui­si­tion of Sil­i­con Val­ley-based Vi­um.

With the pur­chase comes Vi­um’s pro­pri­etary dig­i­tal plat­form that fo­cus­es on new da­ta tools for pre­clin­i­cal stud­ies, in­clud­ing end-to-end in vi­vo re­search. The plat­form us­es com­put­er vi­sion, ma­chine learn­ing and sen­sor tech­nolo­gies to non-in­va­sive­ly col­lect da­ta. Fi­nan­cial terms of the deal were not dis­closed.

Chris Gib­son

“Bring­ing the fan­tas­tic team at Vi­um in-house will en­able us to build on our core tech­nol­o­gy and vi­sion, aug­ment­ing our huge in vit­ro datasets with large, com­ple­men­tary in vi­vo datasets, and ad­vanc­ing our mis­sion to de­code bi­ol­o­gy to rad­i­cal­ly im­prove pa­tient lives,” Re­cur­sion CEO Chris Gib­son said in a state­ment.

Re­cur­sion’s claims about reach­ing hu­man tri­als first, how­ev­er, have been met with push­back from crit­ics, and Gib­son read­i­ly con­ced­ed last Ju­ly that one of the com­pa­ny’s lead pro­grams came out of co-founder Dean Li, who is now the head of trans­la­tion­al re­search at Mer­ck. The biotech’s oth­er clin­i­cal stage drug was in-li­censed from Ohio State. — Max Gel­man

The ar­ti­cle was up­dat­ed to re­flect a sub­se­quent an­nounce­ment from Ridge­back that it had sub­mit­ted its an­ti­body for ap­proval. 

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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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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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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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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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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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.