The an­tibi­otics R&D ef­fort is bro­ken. Here's one mar­ket so­lu­tion that might fix it

Any­one even slight­ly fa­mil­iar with an­tibi­otics R&D over the last 10 years would quick­ly agree that the sys­tem is bad­ly bro­ken.

Big Phar­ma — with the ex­cep­tion of Roche — large­ly pulled out of de­vel­op­ment be­cause the mar­gins are low. The hunt now is for block­busters. There are plen­ty of cheap an­tibi­otics to cov­er most of the mar­ket; the niche for new an­tibi­otics re­mains too small to sus­tain any ma­jor ef­fort need­ed here. The lit­tle biotechs left with the li­on’s share find it’s ex­pen­sive, high­ly risky and hard to make pay. And that is not a pret­ty pic­ture.

So now gov­ern­ment of­fi­cials who have been sound­ing the alarm about the grow­ing risk of drug-re­sis­tant bac­te­ria are look­ing to change the way the mar­ket is struc­tured in or­der to lure big­ger and more am­bi­tious play­ers in­to the game.

That was clear in the UK gov­ern­ment’s re­port, out on Thurs­day, which out­lines a plan to de-cou­ple price from de­mand and shift to a more val­ue-based ap­proach, where in­sti­tu­tions pay fees based on their need for new an­tibi­otics. This is quite sim­i­lar to the li­cens­ing ap­proach that FDA com­mis­sion­er Scott Got­tlieb sug­gest­ed months ago.

While em­bed­ded in a host of sug­ges­tions re­lat­ed to on­go­ing ef­forts to bet­ter mon­i­tor and com­bat drug re­sis­tance, the UK re­port urges a new sys­tem ex­plor­ing how to:

De­vel­op and test new mod­els for na­tion­al pur­chas­ing arrange­ments that de-link the price paid for an­timi­cro­bials from the vol­umes sold, us­ing a NICE led health­care tech­nol­o­gy as­sess­ment to sup­port ro­bust stew­ard­ship.

An­a­lysts at Glob­al­Da­ta of­fered a shout-out for the move.

“The UK gov­ern­ment’s de­ci­sion to ex­plore val­ue-based pric­ing for an­tibi­otics rep­re­sents an im­por­tant step away from the tra­di­tion­al ap­proach of di­rect­ly link­ing pay­ments to sales vol­ume—a pric­ing strat­e­gy that does not work well for an­tibi­otics as it con­flicts with stew­ard­ship ef­forts and ul­ti­mate­ly dis­cour­ages the prop­er use of both new and well-es­tab­lished an­tibi­otics,” not­ed their in­fec­tion dis­ease di­rec­tor Christo­pher Pace. “From the com­mer­cial stand­point, a val­ue-based pric­ing scheme could al­so help to stim­u­late an­tibi­ot­ic R&D as com­pa­nies will be in­cen­tivized to po­si­tion prod­ucts for small­er groups of pa­tients where high un­met med­ical need ex­ists, with­out wor­ry­ing about stymieing re­turn on in­vest­ment.”

We know there’s a mas­sive and grow­ing health prob­lem, but the in­dus­try has been deaf to the five-alarm bells that have been ring­ing. And why not? Char­i­ta­ble R&D for ne­glect­ed dis­eases is a branch of re­search all to it­self, where you can choose to spend — or not — as you will. But there’s no mar­ket­ing glo­ry in it.

Some­thing has to change, and maybe gov­ern­ment of­fi­cials are fi­nal­ly find­ing a path for­ward on a crit­i­cal top­ic. Right now, there is no mar­ket so­lu­tion. 

The oth­er so­lu­tion that the UK re­port echoes is a sug­ges­tion that com­pa­nies be as­sessed a cer­tain amount that they can ei­ther spend on an­tibi­otics or pay as a fee to cov­er the ex­pens­es of those who will. We pre­fer find­ing a mar­ket so­lu­tion as the on­ly sus­tain­able way to get re­al R&D pro­grams off the ground and mov­ing fast. 

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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James Sabry

'We're in': Roche and Genen­tech join forces on a multi­bil­lion-dol­lar dis­cov­ery pact with a brash AI up­start

Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.