UP­DAT­ED: Amid the 'su­per­bug' cri­sis, a Big Phar­ma-backed fund scores a mea­ger raise for an­tibi­otics R&D. Is $140M near­ly enough?

Years af­ter Big Phar­ma aban­doned the an­tibi­otics space, a small syn­di­cate has raised $140 mil­lion to ad­dress the loom­ing threat of an­timi­cro­bial re­sis­tance — but is it too lit­tle, too late?

Back in Ju­ly, more than 20 biotechs — in­clud­ing heavy­weight play­ers Pfiz­er, Eli Lil­ly, No­vo Nordisk, Boehringer In­gel­heim, Bay­er Phar­ma­ceu­ti­cals, Mer­ck KGaA and the Amer­i­can Mer­ck — band­ed to­geth­er to help launch the AMR Ac­tion Fund. With an ini­tial $1 bil­lion, the fund set out to bring two to four new an­tibi­otics to pa­tients by 2030.

Je­re­my Far­rar

On Thurs­day, the fund closed on an­oth­er $140 mil­lion raise from the Boehringer In­gel­heim Foun­da­tion, the Eu­ro­pean In­vest­ment Bank and the Well­come Trust — a fig­ure that pales in com­par­i­son to the tens of bil­lions of VC dol­lars spent in on­col­o­gy over the last decade.

“Sys­temic mar­ket fail­ure has left an­tibi­ot­ic in­no­va­tion starved of fi­nanc­ing, mean­ing po­ten­tial­ly life­sav­ing prod­ucts are un­able to make it to the pa­tients who need them,” Je­re­my Far­rar, di­rec­tor of the Well­come Trust, said in a state­ment, adding that the fund is on­ly “part of the so­lu­tion.”

“The AMR Ac­tion Fund is buy­ing time for the an­tibi­ot­ic pipeline. It is now up to gov­ern­ments to use this time wise­ly and take de­ci­sive ac­tion to fix the mar­ket,” Far­rar added.

It’s es­ti­mat­ed that the rise of su­per­bugs takes 700,000 lives every year, ac­cord­ing to the AMR Fund, which was launched with the help of the WHO and the In­ter­na­tion­al Fed­er­a­tion of Phar­ma­ceu­ti­cal Man­u­fac­tur­ers & As­so­ci­a­tions. By 2050, ex­perts guess an­timi­cro­bial re­sis­tance could lead to as many as 10 mil­lion deaths per year.

But de­spite the ris­ing threat, Big Phar­ma has re­treat­ed from the risky field, fraught with cheap gener­ics and poor fi­nan­cial re­turns. Many an­tibi­otics fail in de­vel­op­ment, while oth­ers “with­er on the vine” due to a lack of avail­able fund­ing. And the ones that do get ap­proved are of­ten used spar­ing­ly to pre­serve ef­fec­tive­ness and slow the de­vel­op­ment of fur­ther re­sis­tance.

No­var­tis — one of the many biotechs chip­ping in­to the AMR Fund — joined the pa­rade of big phar­mas ex­it­ing the field two years ago when it culled its an­tibac­te­r­i­al and an­tivi­ral re­search ef­forts. As­traZeneca, Sanofi and Al­ler­gan had al­ready aban­doned their own pro­grams, which, fol­lowed by a slew of bank­rupt­cies, left few oth­ers in pur­suit of a so­lu­tion to an­timi­cro­bial re­sis­tance.

“Nev­er has the threat of an­timi­cro­bial re­sis­tance been more im­me­di­ate and the need for so­lu­tions more ur­gent,” Tedros Ad­hanom Ghe­breye­sus, WHO di­rec­tor-gen­er­al, said in a Jan­u­ary 2020 state­ment.

The AMR Fund isn’t the on­ly ini­tia­tive look­ing to spur new de­vel­op­ment in the space. CARB-X launched in 2016, with the goal of pump­ing up to $480 mil­lion in­to ear­ly projects through 2022. Since its launch, CARB-X has an­nounced 78 awards worth more than $284.4 mil­lion, not count­ing po­ten­tial mile­stones.

“We need in­no­v­a­tive so­lu­tions to avert the loom­ing health cri­sis posed by AMR, which threat­ens to make even com­mon med­ical pro­ce­dures po­ten­tial­ly dead­ly,” said Christoph Boehringer, chair­man of the Boehringer In­gel­heim Foun­da­tion which con­tributed $50 mil­lion to the cause.

Isaac Ston­er, CEO at Oc­ta­gon Ther­a­peu­tics, said the fundrais­ing ef­forts are “re­al­ly in­ter­est­ing, but I have un­for­tu­nate­ly be­come a pes­simist.” He added:

This seems like a sim­i­lar mech­a­nism to the No­vo RE­PAIR fund and CARB-X. It’s a nice idea, but still a very small amount of mon­ey and doesn’t fix the ac­tu­al prob­lem. As they de­scribe them­selves, this is “buy­ing time” for re­al ac­tion. As COVID vac­cine de­vel­op­ment has shown, if gov­ern­ments sign pur­chase con­tracts around large vol­umes of these prod­ucts at guar­an­teed price points, that can re­al­ly help to stim­u­late de­vel­op­ment. But these push in­cen­tives are a bridge to nowhere, as long as the mar­ket op­por­tu­ni­ty is cou­pled to uti­liza­tion.

Ankit Ma­hade­via, founder and CEO of Spero Ther­a­peu­tics, said it’s “help­ful to see the com­mit­ment to find­ing bet­ter so­lu­tions for in­fec­tions.”

“Our re­spon­si­bil­i­ty as biotechs is to find sci­en­tif­i­cal­ly in­no­v­a­tive med­i­cines that meet true un­met needs in sus­tain­able mar­kets and the fund can help us in that mis­sion,” he con­tin­ued.

Com­par­ing the threat to the nov­el coro­n­avirus, which was “prac­ti­cal­ly un­known” un­til last year, the AMR Fund said an­timi­cro­bial re­sis­tance is “a threat we know, and we must take col­lec­tive ac­tion now.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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