Pfiz­er spins off drug or­phans in­to a PhI­II-ready start­up backed by Bain to the tune of $103M

Like a lot of Big Phar­ma com­pa­nies with a big pipeline, Pfiz­er can’t de­vel­op all the drugs it has. So what do you do with the good drugs that still can’t make the cut?

In Pfiz­er’s case, you spin a line­up of your best, fur­thest ad­vanced ex­per­i­men­tal meds in­to a new com­pa­ny, while look­ing to add more when the time is ripe.

Lara Sul­li­van, an R&D strat­e­gy ex­ec, has gained the com­pa­ny’s sup­port to split off from the phar­ma gi­ant with four of its clin­i­cal-stage or­phans, cre­at­ing a new com­pa­ny called Spring­Works Ther­a­peu­tics. And with con­sid­er­able help from two big Bain funds, they’re start­ing out with a mega-round of $103 mil­lion for the Se­ries A.

Lara Sul­li­van

Sul­li­van, the new­ly un­veiled pres­i­dent of Spring­Works, says she gained con­sid­er­able sup­port for this new ven­ture from Pfiz­er’s chief med­ical of­fi­cer Fre­da Lewis-Hall, who is tak­ing a board spot on Spring­Works to help over­see the fu­ture of these drugs, with Pfiz­er lend­ing its fi­nan­cial sup­port along­side Bain Cap­i­tal Life Sci­ences, Bain Cap­i­tal Dou­ble Im­pact, Or­bimed and LifeArc.

It’s no easy task grab­bing four drugs out of the pipeline at a glob­al op­er­a­tion like Pfiz­er, even if they haven’t made the cut on R&D fund­ing.

“I’ve got a cou­ple of more gray hairs than I did a few years ago,” Sul­li­van tells me, when she got start­ed pur­su­ing this project. Lewis-Hall helped cham­pi­on the ef­fort, and then they built sup­port among the com­pa­ny’s lawyers, ac­coun­tants and sci­en­tists, who are on­ly too aware that even in a top 10 R&D out­fit like Pfiz­er  there are far more de­vel­op­ment projects than mon­ey to fund the work.

Sul­li­van tells me they’re still grow­ing the staff, but the top po­si­tions are oc­cu­pied by some high-pro­file fig­ures in the in­dus­try — from Chair­man Dan Lynch, to Bain Cap­i­tal Dou­ble Im­pact’s De­val Patrick, the for­mer gov­er­nor of Mass­a­chu­setts, on the board. Stephen Squin­to, a co-founder and for­mer R&D chief of Alex­ion — now a ven­ture part­ner at Or­biMed — is step­ping in as act­ing head of re­search at the up­start. Jeff Schwartz, a gen­er­al part­ner at Bain’s re­cent­ly cre­at­ed life sci­ences group along­side Adam Kop­pel, is al­so tak­ing a spot on the board.

Spring­Works is a di­rect out­growth of an in­creas­ing­ly com­mon strat­e­gy that is find­ing an abun­dance of deep-pock­et play­ers — in­clud­ing some ma­jor out­fits that are new to the game — who are ready to gam­ble hun­dreds of mil­lions of dol­lars on drug R&D.

Just like Vivek Ra­maswamy, who’s built a grow­ing biotech en­ter­prise with mul­ti­ple ten­ta­cles around Roivant Sci­ences with the castoffs to be found in Big Phar­ma, Whar­ton grad Sul­li­van found a way to jump­start a ma­ture biotech with a pipeline of ad­vanced as­sets with hu­man da­ta. And with a slate of new CEOs tak­ing over ma­jor R&D shops, shift­ing fo­cus and re­al­lo­cat­ing funds, this is one trend that seems to be gain­ing mo­men­tum.

It doesn’t stop here, ei­ther, for Spring­Works. Sul­li­van and her team are work­ing with Pfiz­er and oth­ers in the in­dus­try and acad­e­mia to find more clin­i­cal-stage drugs they can add to the pipeline to grow the com­pa­ny even fur­ther.

Spring­Works has plen­ty on its plate to get start­ed. Pfiz­er, like most of the ma­jor phar­ma com­pa­nies, tends to stick to its late-stage pipeline when they talk up R&D, so these drugs have been fly­ing large­ly un­der the radar.

  • The lead drug is nirogace­s­tat (PF-03084014), a gam­ma-sec­re­tase in­hibitor which will be moved in­to Phase III now for rare cas­es of desmoid tu­mors, a slow-grow­ing non-metasta­t­ic tu­mor of con­nec­tive tis­sue cells, which can cause se­vere mor­bid­i­ty, pain and loss of func­tion.
  • There’s a MEK 1/2 in­hibitor, PF-0325901, for the ge­net­ic dis­or­der NF1, one of three ge­net­ic con­di­tions known as neu­rofi­bro­mato­sis. It’s been through Phase I/II and will now head in­to a piv­otal tri­al.
  • An­oth­er rare con­di­tion, hered­i­tary xe­ro­cy­to­sis — char­ac­ter­ized by de­hy­drat­ed red blood cells — will be tar­get­ed by sen­i­capoc (PF-05416266).
  • An FAAH in­hibitor (PF-0445784) is be­ing de­vel­oped for post-trau­mat­ic stress dis­or­der.

To get in­to the Spring­Works pipeline, the drugs had to pass two fa­mil­iar chal­lenges in the biotech world: Was it tar­get­ing a dis­ease where there are no good drugs to choose from? And was there enough hard sci­ence to back up their po­ten­tial in mak­ing the grade with piv­otal da­ta?

Based on their work at Pfiz­er so far, there are plen­ty more like this out there.

“We an­tic­i­pate there will be plen­ty of more com­pounds,” says Sul­li­van.

At this stage, there’s no telling ex­act­ly how long the $103 mil­lion will last, though they ex­pect at a min­i­mum to get through the late-stage work on mid-stage proof-of-con­cept stud­ies on the 4. The com­pa­ny has a set of big names be­hind it, but the staff is still un­der 10, though grow­ing 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.

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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.

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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.

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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.

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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.

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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.