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.”

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.