$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.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

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Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.