Joanna Shields, BenevolentAI CEO (Andreas Gebert/picture-alliance/dpa/AP Images)

Af­ter nab­bing two AI-gen­er­at­ed mol­e­cules, As­traZeneca re­turns to Benev­o­len­tAI with new col­lab­o­ra­tion

Rough­ly three years ago, As­traZeneca teamed up with Lon­don’s Benev­o­len­tAI to bring new drugs in­to its port­fo­lio us­ing the biotech’s AI and ma­chine learn­ing ca­pa­bil­i­ties. Now that the orig­i­nal deal has borne fruit, the two com­pa­nies are re-up­ping their col­lab­o­ra­tion.

As­traZeneca and Benev­o­len­tAI will work to­geth­er in two more dis­ease ar­eas: sys­temic lu­pus and heart fail­ure, the com­pa­nies an­nounced Thurs­day. It’s a three-year part­ner­ship that comes af­ter two can­di­dates dis­cov­ered by Benev­o­len­tAI for chron­ic kid­ney dis­ease and id­io­path­ic pul­monary fi­bro­sis were nom­i­nat­ed to As­traZeneca’s port­fo­lio last year.

No fi­nan­cials were dis­closed, but Benev­o­len­tAI CSO Anne Phe­lan told End­points News there would be an up­front pay­ment, an eq­ui­ty in­vest­ment and mile­stones.

The orig­i­nal part­ner­ship proved a sig­nif­i­cant mile­stone for As­traZeneca, as the CKD mol­e­cule nom­i­nat­ed last Jan­u­ary was the com­pa­ny’s first gen­er­at­ed by AI. At the time, As­traZeneca iden­ti­fied and val­i­dat­ed a new way to at­tack CKD thanks to the biotech’s plat­form AI tech, and be­gan de­vel­op­ing com­pounds cen­tered on this tar­get.

The IPF com­pound fol­lowed up just last month, and now marks the “per­fect time” to ex­tend the work­ing re­la­tion­ship, Phe­lan said.

Lu­pus and heart fail­ure “fall with­in [As­traZeneca’s] pri­or­i­ty ther­a­peu­tic ar­eas,” Phe­lan said. “They’re com­plex dis­eases, dif­fi­cult spaces to work in. It’s a tricky prob­lem that lends it­self well to AI and our ma­chine learn­ing ca­pa­bil­i­ties.”

At the heart of Benev­o­len­tAI’s tech­nol­o­gy is what Phe­lan de­scribes as a “knowl­edge graph,” which es­sen­tial­ly looks like a “hair­ball” net­work of thou­sands of da­ta points, or nodes, in­ter­con­nect­ed by mil­lions of lines or re­la­tion­ships. Such re­la­tion­ships are first iden­ti­fied by the ma­chine learn­ing al­go­rithms and can con­nect many dif­fer­ent and un­re­lat­ed dis­eases.

Anne Phe­lan

Benev­o­len­tAI is able to dif­fer­en­ti­ate it­self from the buzzy and grow­ing field of AI drug de­vel­op­ment be­cause it is dri­ven by a hy­poth­e­sis-first ap­proach rather than fo­cus­ing on phe­no­typ­ic screen­ing, Phe­lan added. Where­as com­peti­tors’ AI might be mak­ing new mol­e­cules and try­ing to re­verse-en­gi­neer the process, Benev­o­len­tAI starts from scratch.

“It’s not a right and wrong sit­u­a­tion … it’s a re­al­ly mul­ti­di­men­sion­al pic­ture of hu­man bi­ol­o­gy across the com­mon­al­i­ties of hu­man dis­ease,” Phe­lan said. “For ex­am­ple, de­pend­ing on the cell type that’s af­fect­ed, the graph could end up con­nect­ing to Alzheimer’s or di­a­betes, where un­der­ly­ing phys­i­ol­o­gy could be re­al­ly quite sim­i­lar.”

For As­traZeneca, lu­pus re­cent­ly turned in­to a po­ten­tial mon­ey­mak­er, as the Big Phar­ma whisked a new drug past the FDA fin­ish line last Au­gust in Saph­ne­lo. It’s the first new lu­pus ap­proval in at least the last 10 years, As­traZeneca said at the time, and re­duces over­all dis­ease ac­tiv­i­ty across or­gan sys­tems and oral cor­ti­cos­teroid use com­pared to place­bo.

Heart fail­ure, mean­while, is an area where As­traZeneca is look­ing to stake out a block­buster with Farx­i­ga. Back in 2020, the drug was ap­proved to re­duce the risk of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion in heart fail­ure pa­tients with a re­duced ejec­tion frac­tion. It al­so picked up an ap­proval in CKD last April.

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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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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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.