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. 

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA.