En­terome for­ti­fies Take­da re­la­tion­ship with $50M up­front to co-de­vel­op Crohn's drug

Pri­vate­ly held French biotech En­terome SA has scored a cool $50 mil­lion up­front to co-de­vel­op its ex­per­i­men­tal ear­ly-stage Crohn’s dis­ease drug with Take­da in its sec­ond col­lab­o­ra­tion with the Japan­ese drug­mak­er.

The mi­cro­bio­me-fo­cused En­terome — which al­ready boasts of col­lab­o­ra­tions with big Phar­ma play­ers such as John­son & John­son $JNJ, Bris­tol-My­ers $BMY — is set to work with Take­da $TKPYY in de­vel­op­ing EB8018, a small mol­e­cule de­signed to se­lec­tive­ly dis­arm vir­u­lent bac­te­ria in the gut that can cause in­flam­ma­tion, with­out dis­rupt­ing the lo­cal mi­cro­bio­me.

In­ter­est in har­ness­ing the mi­cro­bio­me — the ge­net­ic ma­te­r­i­al of all the mi­crobes such as bac­te­ria, fun­gi, and virus­es that live on and in­side the hu­man body — has ex­plod­ed in re­cent years, as emerg­ing ev­i­dence sug­gests these mi­crobes, par­tic­u­lar­ly those found in the gut, play a sig­nif­i­cant role in main­tain­ing health, pro­tect­ing against dis­ease and/or help­ing fight ill­ness. The glob­al mar­ket for mi­cro­bio­me ther­a­peu­tics is ex­pect­ed to sur­pass $890 mil­lion by 2025, es­ti­mates Per­sis­tence mar­ket re­search.

Com­pa­nies such as Seres and Re­bi­otix are rac­ing to de­vel­op so-called “crap­sules,” or pel­lets con­tain­ing healthy fe­cal mat­ter, as a less-icky al­ter­na­tive to fe­cal trans­plants typ­i­cal­ly fa­cil­i­tat­ed via a colonoscopy or en­e­ma, to trans­fer ‘good bac­te­ria’ as a last re­sort treat­ment for re­cur­rent clostrid­i­um dif­fi­cile, a stub­born bac­te­r­i­al in­fec­tion, among oth­er in­di­ca­tions. Da­ta al­so shows mi­crobes can help de­press the im­mune sys­tem re­sponse in pa­tients with in­flam­ma­to­ry dis­or­ders, or ac­cel­er­ate it for dis­eases like can­cer. For in­stance, cer­tain bac­te­ria are use­ful against can­cer as they are be­lieved to smoothen the path for PD-1 im­munother­a­pies that are de­signed to take the brakes off the im­mune sys­tem, a mech­a­nism that Seres Ther­a­peu­tics is cur­rent­ly in­ves­ti­gat­ing in clin­i­cal tri­als.

En­terome has al­so made strides in this di­rec­tion. It inked a deal with Bris­tol-My­ers in 2016 to de­vel­op mi­cro­bio­me-de­rived di­ag­nos­tic tests as well as bio­mark­ers and po­ten­tial drugs to use in tan­dem with the U.S. drug­mak­ers im­munother­a­py plat­form.

In ad­di­tion to the up­front in­vest­ment for EB8018, Take­da has al­so pledged a fu­ture eq­ui­ty in­vest­ment on En­terome, the com­pa­nies said on Tues­day. If EB8018, which is cur­rent­ly in Phase I test­ing, meets cer­tain clin­i­cal, reg­u­la­to­ry and com­mer­cial mile­stones, it is al­so el­i­gi­ble to re­ceive an­oth­er hefty $640 mil­lion. If ap­proved, the prod­uct will be co-pro­mot­ed in the Unit­ed States un­der a prof­it/cost-shar­ing struc­ture. Take­da will be in charge of sell­ing the drug out­side the US, with En­terome el­i­gi­ble to re­ceive roy­al­ties on net sales in these ter­ri­to­ries.

The tie-up builds on a 2016 deal, in which the two com­pa­nies agreed to join forces to fo­cus on mi­cro­bio­me tar­gets across mul­ti­ple gas­troin­testi­nal dis­or­ders.

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.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.