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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

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An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

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No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

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Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

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