$100B in NIH-fund­ed re­search played an im­por­tant role in all 210 new drugs ap­proved over 7 years — study

The next time some­one chal­lenges the im­por­tance of NIH-fund­ed re­search in drug de­vel­op­ment, you might want to point them to a new study that high­lights the foun­da­tion­al role the In­sti­tutes plays in bio­phar­ma re­search.

The study — pub­lished in the Pro­ceed­ings of the Na­tion­al Acad­e­my of Sci­ences — con­cludes that every one of the 210 new mol­e­c­u­lar en­ti­ties ap­proved by the FDA be­tween 2010 and 2016 can source re­search back to NIH-fund­ed work. That is es­pe­cial­ly im­por­tant in fig­ur­ing the pub­lic con­text of first-in-class work, where ba­sic re­search played a sig­nif­i­cant role in the sci­en­tif­ic un­der­stand­ing of the tar­gets in­volved.

From the study by a team of re­searchers at Bent­ley Uni­ver­si­ty:

These da­ta demon­strate that a siz­able pub­lic-sec­tor in­vest­ment oc­curs be­fore the ap­proval of first-in-class NMEs, par­tic­u­lar­ly those dis­cov­ered us­ing tar­get­ed dis­cov­ery meth­ods (in­clud­ing re­com­bi­nant bi­o­log­i­cals). The scale of this in­vest­ment can be es­ti­mat­ed from the costs as­so­ci­at­ed with first-in-class NMEs ap­proved in 2010–2016 and their mol­e­c­u­lar tar­gets. These da­ta sug­gest that the pub­lic-sec­tor in­vest­ment in re­search un­der­ly­ing each first-in-class drug is as high as $839 mil­lion, with 89% of this cost as­so­ci­at­ed with tar­get re­search and 11% of the cost as­so­ci­at­ed with the first-in-class com­pound or fol­low-on com­pounds ap­proved from 2010–2016….

Over­all, this analy­sis sug­gests that as much as 20% of the NIH bud­get al­lo­ca­tion from 2000–2016 (more than $100 bil­lion) was as­so­ci­at­ed with pub­lished re­search that di­rect­ly or in­di­rect­ly con­tributed to NMEs ap­proved from 2010–2016.

The au­thors in par­tic­u­lar want­ed to ex­pand the scope of their re­search to make sure they were ac­count­ing for NIH-fund­ed stud­ies that were es­sen­tial to a drug tar­get, which doesn’t al­ways fac­tor in­to the patents used to pro­tect the com­mer­cial val­ue of each drug — a stan­dard that had been used in ear­li­er at­tempts to high­light the role of the NIH in drug de­vel­op­ment.

No one at the NIH is like­ly to get any kick­back from bio­phar­ma on this score. NIH fund­ing has been un­der the gun un­der Pres­i­dent Don­ald Trump, who’s been ready to sac­ri­fice re­search spend­ing in fa­vor of oth­er pri­or­i­ties. But the NIH bud­get has been saved by a bi­par­ti­san pha­lanx of elect­ed of­fi­cials in Con­gress who have ral­lied against the cuts. They’ll be back on the front­line of this de­bate now that Trump has sub­mit­ted a new bud­get this week that calls on law­mak­ers to flat­line spend­ing at the In­sti­tutes.

Those de­fend­ers just got some fresh am­mu­ni­tion for the fights to come.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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