Roche ties a $387M knot with Warp Dri­ve Bio in col­lab­o­ra­tion spot­light­ing new class­es of an­tibi­otics

Four years af­ter Roche sig­naled its re­turn to the an­tibi­otics field, with mixed re­sults, the phar­ma gi­ant is turn­ing to the ge­nom­ic draw­ing board at Warp Dri­ve Bio to see if it can use the biotech’s tech plat­form to hunt down some com­plete­ly new class­es of an­tibi­otics.

Lau­rence Reid

The deal with Roche’s big pRED or­ga­ni­za­tion in Basel — un­der John Reed — comes with an up­front and pre­clin­i­cal mile­stones of $87 mil­lion, with an­oth­er $300 mil­lion on the line for the rest of the de­vel­op­ment and po­ten­tial sales mile­stones un­der the deal.

In re­turn Warp Dri­ve will do for Roche what it’s been do­ing for Sanofi and oth­er big part­ners, us­ing a plat­form tech orig­i­nal­ly de­vised by Har­vard sci­en­tist and se­r­i­al biotech en­tre­pre­neur Greg Ver­dine in search­ing for clues pro­duced by Moth­er Na­ture to come up with new breeds of an­tibi­otics that can com­bat the in­creas­ing­ly drug-re­sis­tant tar­gets they’re go­ing af­ter.

“The work with Roche is re­al­ly fo­cused on dis­cov­er­ing tru­ly nov­el class­es of an­tibi­otics,” says Lau­rence Reid, who took Ver­dine’s place as CEO a cou­ple of years ago. And that hasn’t been done in 30 years, since dap­to­mycin was dis­cov­ered and de­vel­oped.

The genome min­ing plat­form at Warp Dri­ve “in­cludes a ge­nom­ic data­base of se­quences of bac­te­ria that live in the soil,” says Reid. Us­ing bioin­for­mat­ics tech, they can “search in se­quences for sig­na­tures of genes that en­code the biosyn­thet­ic ma­chin­ery for nov­el com­pounds.”

“We hunt for clus­ters that we pre­dict will en­code nov­el com­pounds,” he adds, search­ing for po­ten­tial an­tibi­otics and then mod­i­fy­ing them. The hunt is on for new mech­a­nisms of ac­tion and new chem­i­cal struc­tures against known tar­gets.

Roche and vir­tu­al­ly every oth­er Big Phar­ma play­er once ac­tive in an­tibi­otics aban­doned the field years ago, turned off by the thin mar­gins and poor fi­nan­cial prospects for a niche now dom­i­nat­ed by cheap gener­ics. A va­ri­ety of small biotechs have been field­ing non-in­fe­ri­or an­tibi­otics that can step in for drug-re­sis­tant cas­es, and as the cur­rent crop grad­u­al­ly plays out with ever-weak­en­ing re­sults, the prospect that nov­el an­tibi­otics can come along could prove much more at­trac­tive for ma­jor de­vel­op­ers.

Roche should have plen­ty of time to see those eco­nom­ics work out in this dis­cov­ery deal.

Karen Bush, In­di­ana Uni­ver­si­ty

It’s no easy quest. The phar­ma gi­ant’s pRED R&D group — as dis­tinct from the gRED arm at Genen­tech — jumped back in­to an­tibi­otics with a col­lab­o­ra­tion with Polyphor, but dropped it two years lat­er. Last April, Polyphor nailed down a $40 mil­lion round to fund late-stage work on Murepavadin (POL7080), an an­tibi­ot­ic aimed at guard­ing against in­fec­tions in the air­ways of cys­tic fi­bro­sis pa­tients.

Said In­di­ana Uni­ver­si­ty Pro­fes­sor Karen Bush:
With the in­no­v­a­tive plat­form de­vel­oped by Warp Dri­ve, there is the po­ten­tial to dis­cov­er nov­el nat­ur­al prod­uct an­tibi­otics, his­tor­i­cal­ly hid­den with­in mi­crobes. These pre­vi­ous­ly un­tapped an­tibi­ot­ic class­es may play a key role in the fu­ture strat­e­gy to com­bat an­timi­cro­bial re­sis­tance.
Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.