UK courts an­tibi­ot­ic de­vel­op­ers with 'sub­scrip­tion-style' in­cen­tive to com­bat su­per­bug scourge

As an­tibi­ot­ic de­vel­op­ers lan­guish, and su­per­bugs flour­ish, the Unit­ed King­dom is tak­ing a key step to in­vig­o­rate an­timi­cro­bial de­vel­op­ment by woo­ing man­u­fac­tur­ers with the in­cen­tive of a ‘sub­scrip­tion’ style pay­ment:  the drugs will be paid for, even if they’re just stored in re­serves.

It is no se­cret that the in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are fast dwin­dling. Drug­mak­ers are en­ticed by green­er pas­tures, com­pared to the long, ar­du­ous and ex­pen­sive path to an­tibi­ot­ic ap­proval that of­fers lit­tle fi­nan­cial gain as treat­ments must be priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them. Con­se­quent­ly, there has been no new class of an­tibi­otics ap­proved since the 1980s — and to­day, rough­ly 700,000 deaths an­nu­al­ly are at­trib­uted to drug re­sis­tant bac­te­ria, ac­cord­ing to the WHO.

For one of the biggest threats to glob­al health, the li­on’s share of an­tibi­ot­ic de­vel­op­ment is tak­ing place in a hand­ful of labs of small bio­phar­ma com­pa­nies as their larg­er coun­ter­parts fo­cus on more lu­cra­tive en­deav­ors. In re­cent months, a hand­ful of an­tibi­ot­ic de­vel­op­ers — in­clud­ing Achao­gen and Tetraphase — have seen their val­ue go up in smoke as fee­ble sales frus­trate growth.

Joan But­ter­ton Mer­ck 

Ex­ist­ing in­cen­tives to en­tice an­tibi­ot­ic R&D are too weak to fix this bro­ken sys­tem, drug­mak­ers, pub­lic health or­ga­ni­za­tions and doc­tors have as­sert­ed, ask­ing pol­i­cy­mak­ers to take a fresh ap­proach to stim­u­late drug de­vel­op­ment by en­act­ing pol­i­cy mea­sures to in­crease the val­ue of a mar­ket­ed an­tibi­ot­ic.

In the Unit­ed States, in­cen­tives are al­ready in place to push drug­mak­ers to de­vel­op an­tibi­otics — but the in­dus­try is clam­or­ing for the pas­sage of “pull in­cen­tives,” or pol­i­cy mea­sures to in­crease the val­ue of a mar­ket­ed an­tibi­ot­ic by re­ward­ing drug­mak­ers on­ly af­ter their an­tibi­ot­ic is ap­proved. The ini­tia­tive by the UK, first broad­ly dis­cussed in a five-year ac­tion plan pub­lished by the gov­ern­ment in Jan­u­ary, is such a “pull in­cen­tive”.

The project, led by NICE and NHS Eng­land, in­volves de­vel­op­ing and test­ing a mod­el that pays com­pa­nies for an­timi­cro­bials based pri­mar­i­ly on their ex­pect­ed val­ue to the Na­tion­al Health Ser­vice (NHS), as op­posed to the ac­tu­al vol­ume used.

In the first phase of the project — ex­pect­ed to be com­plet­ed by the end of the year — the agen­cies will struc­ture a re­im­burse­ment and pay­ment mod­el, and se­lect two prod­ucts to un­der­go the tri­al as­sess­ment and com­mer­cial dis­cus­sions. By the end 2020, the eval­u­a­tion of the two prod­ucts is ex­pect­ed to con­clude, and the au­thor­i­ties will de­ter­mine whether the cur­rent sys­tem of de­ploy­ing an­timi­cro­bials should be amend­ed, NICE said.

Find­ings will be shared across the world, so oth­er health­care sys­tems can test sim­i­lar mod­els, the UK de­part­ment of health and so­cial care added on Tues­day.

“Imag­ine a world in which a pa­per­cut can lead to in­fec­tion that can’t be con­trolled…Tack­ling su­per­bugs needs glob­al lead­er­ship and peo­ples’ lives de­pend on us find­ing a new way for­ward,” UK Health and So­cial Care Sec­re­tary Matt Han­cock said in a state­ment.

Drug-re­sis­tant in­fec­tions in hu­mans in­creased by 35% from 2013 to 2017 in Eng­land, ac­cord­ing to es­ti­mates by Pub­lic Health Eng­land. The UK gov­ern­ment has set the lofty goal of con­tain­ing and con­trol­ling an­timi­cro­bial re­sis­tance by 2040.

Joan But­ter­ton, as­so­ciate VP of clin­i­cal re­search, in­fec­tious dis­eases at Mer­ck — one of the re­main­ing large drug­mak­ers in the an­timi­cro­bial space — sug­gest­ed that the UK’s ‘pull in­cen­tive’ pro­pos­al was en­cour­ag­ing, in an in­ter­view with End­points News ear­li­er this month.

What the UK is do­ing “is ex­act­ly what we need — we need to think of mul­ti­ple ways of in­cen­tiviz­ing com­pa­nies in the space and to be able to en­sure that they have a guar­an­teed and pre­dictable in­come,” she said.

Last year, for­mer FDA com­mis­sion­er Scott Got­tlieb sug­gest­ed a “li­cens­ing mod­el” in which acute care in­sti­tu­tions that pre­scribe an­timi­cro­bial med­i­cines would pay a fixed li­cens­ing fee for ac­cess to these drugs, grant­i­ng them the right to use a cer­tain num­ber of an­nu­al dos­es.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

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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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.