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.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Olivier Brandicourt (AP Images)

Ex-Sanofi chief Olivi­er Brandi­court, cur­rent Black­stone ad­vi­sor, jumps on Al­ny­lam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

Jim Wilson's gene ther­a­py start­up Pas­sage Bio bucks mar­ket sen­ti­ments, rais­ing up­sized $216M IPO

A coronavirus fear-induced bloodbath on the Nasdaq has not stopped Passage Bio from making a public debut — and an exuberant one.

By pricing an upsized offering at $18, the top of the range, the gene therapy biotech bagged $216 million from its IPO, 72% more than it’s originally penciled in.

The proceeds likely reflected confidence in Jim Wilson, who gathered all the tools he’s built over decades of gene therapy research to assemble the startup and teamed up with Frazier and OrbiMed to hone its focus on rare, monogenic disorders of the central nervous system. Just before the IPO, Deerfield partner Bruce Goldsmith took over from OrbiMed’s Stephen Squinto as CEO.

Dan O'Day (AP Images)

UP­DAT­ED: A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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