Phar­ma gi­ants re­turn to an­tibi­otics hud­dle to launch $1B ven­ture fund — re­port

Big Phar­ma ex­it­ed from the an­tibi­otics space one by one. And now they may be com­ing back to­geth­er.

Pfiz­er, Eli Lil­ly, No­vo Nordisk, Boehringer In­gel­heim, Bay­er Phar­ma­ceu­ti­cals, Mer­ck KGaA and the Amer­i­can Mer­ck — one of the last gi­ants stand­ing — are team­ing up to cre­ate a $1 bil­lion for-prof­it ven­ture to bet on small biotechs de­vel­op­ing mid-stage an­tibi­otics, Ed Sil­ver­man re­port­ed for STAT.

Gov­ern­ment of­fi­cials from Ger­many, Swe­den, France and the UK, as well as rep­re­sen­ta­tives from Well­come Trust and Pew Char­i­ta­ble Trusts, will join the com­pa­nies to an­nounce the ini­tia­tive on Ju­ly 9, Sil­ver­man wrote. The World Health Or­ga­ni­za­tion and the Eu­ro­pean In­vest­ment Bank are al­so in­volved in what is be­ing billed as a new so­lu­tion to the “an­tibi­ot­ic in­no­va­tion chal­lenge.”

Con­sid­er­ing the num­ber of play­ers and the col­lec­tive heft they bring — plus the fact that the EIB might con­tribute as much as 10% — the mon­ey isn’t much. By phar­ma stan­dards, $1 bil­lion won’t even buy you a bolt-on deal, typ­i­cal­ly in the $2 bil­lion to $5 bil­lion range. It al­so marks the thresh­old for block­buster sta­tus that any big can­cer drug fran­chise could eas­i­ly sur­pass.

Still, mil­lions of dol­lars could pro­vide a life­line for biotechs starved of cash, es­pe­cial­ly in a field that many VCs are stay­ing out of.

Just days ago La Jol­la sealed the third — and seem­ing­ly fi­nal — buy­out for Tetraphase and its com­mer­cial an­tibi­ot­ic, pre­vail­ing over mul­ti­ple com­pet­ing bids by Acel­Rx and Melin­ta. And even that on­ly cost $43 mil­lion in up­front cash and $16 mil­lion in po­ten­tial CVRs.

The key ques­tion will be whether the cre­ation of this new ven­ture, which Sil­ver­man de­scribed as an ex­ten­sion of the work of pub­lic-pri­vate part­ner­ship CARB-X in back­ing ear­ly-stage an­tibi­otics de­vel­op­ment, will be ac­com­pa­nied by changes in the re­im­burse­ment sys­tem. At the end of the day, if de­vel­op­ers can’t make much mon­ey off their drugs, in­vestors may not see a point in try­ing to help get them ap­proved at all.

As con­cerns about an­tibi­ot­ic re­sis­tance loom ever larg­er, though, the ef­fort it­self may count.

“The think­ing is that, ide­al­ly, if they put mon­ey in [the fund], this will serve them in the long run, but al­so make them look good,” reads a key quote. “They got pret­ty bad press when they walked out on an­tibi­otics.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Neil Desai, Aadi Bioscience CEO (via YouTube)

Pre­ci­sion on­col­o­gy biotech agrees to $72M cash in­fu­sion as it seeks to in­crease rev­enue

Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going.

The oncology player announced Thursday that it has engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share, the biotech’s closing price at Nasdaq on Wednesday. The company is also selling off pre-funded warrants to purchase over 2.4 million more shares at $12.4999 per pre-funded warrant.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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