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.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Federal Trade Commission commissioner Rohit Chopra testifies on Capitol Hill (AP Photo/Susan Walsh)

FTC clears Bris­tol-My­ers’ $74B deal to buy Cel­gene — but Dems sig­nal a po­ten­tial hard shift against Big Phar­ma M&A

Bristol-Myers Squibb’s record $74 billion takeover of Celgene is a done deal. And it will all be over — except for the lingering complaints from die-hard Celgene investors — on Wednesday.

Like much else that’s going on in Washington these days, the vote among the 5 FTC commissioners split along party lines, with the 3 Republicans voting to clear the way and the 2 Democrats steamed over what they see as a major M&A move that will lessen competition and innovation. And that split has big implications for the M&A side of the business if the Dems take the White House in 2020.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: In a first, FDA green-lights use of a Chi­nese built can­cer ther­a­py — and more are com­ing

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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