Ab­b­Vie ad­vances its two star pipeline ther­a­pies, fil­ing BLA for risankizum­ab and post­ing promis­ing da­ta for upadac­i­tinib

Ab­b­Vie racked up an­oth­er round of promis­ing da­ta for its late-stage rheuma­toid arthri­tis drug upadac­i­tinib. All three dos­es — 7.5 mg, 15 mg and 30 mg — in their Phase IIb/III study in Japan met the pri­ma­ry end­point of ACR20 ver­sus place­bo. And there were no ma­jor car­dio events to speak in­vestors this time, with no deaths, no events of pul­monary em­bolism or deep vein throm­bo­sis re­port­ed. Ab­b­Vie has high hopes for this drug, which is com­pet­ing against some ma­jor league ri­vals. The bio­phar­ma com­pa­ny has pegged peak po­ten­tial sales at $6.5 bil­lion.

→ While Ab­b­Vie was adding pos­i­tive da­ta to its RA drug, the com­pa­ny was al­so push­ing its oth­er star pipeline ther­a­py to­ward a po­ten­tial OK, fil­ing a BLA for FDA ap­proval. Ab­b­Vie paid Boehringer $595 mil­lion up­front to li­cense rights to risankizum­ab in ear­ly 2016, and last fall the com­pa­ny dis­played a late-stage dataset on pso­ri­a­sis ex­plain­ing why they want­ed this drug so bad­ly, stay­ing on track to cre­at­ing a new fran­chise play­er the phar­ma com­pa­ny be­lieves can reg­is­ter $4 bil­lion to $5 bil­lion in peak an­nu­al sales.

→ Al­most a year af­ter launch­ing out of X-Chem, X-Bi­otix Ther­a­peu­tics has brought in a key ex­ec, two board di­rec­tors and $7 mil­lion in Se­ries A fund­ing. As chief sci­en­tif­ic of­fi­cer, Do­minic Ryan — a for­mer dis­cov­ery di­rec­tor at Cu­bist Phar­ma — will steer the biotech’s re­search strat­e­gy as it pur­sues an­tibi­ot­ic scaf­folds for mul­ti-drug re­sis­tant Gram-neg­a­tive pathogens. Waltham, MA-based X-Bi­otics is build­ing a pipeline based up­on X-Chem’s DNA en­cod­ing tech­nol­o­gy and a col­lab­o­ra­tion with sev­er­al mi­cro­bi­ol­o­gy spe­cial­ists at Har­vard. Al­so join­ing the com­pa­ny are Aduro Biotech CEO Stephen Isaacs and pri­vate eq­ui­ty part­ner Christo­pher Ray, ap­point­ed to help grow the ear­ly-stage com­pa­ny.

→ Beef­ing up its in­fec­tious dis­ease pipeline, Zai Lab $ZLAB has paid As­traZeneca spin­off En­ta­sis $5 mil­lion up­front to li­cense and part­ner on ETX2514, a broad-spec­trum in­tra­venous in­hibitor of β-lac­ta­mases. In par­tic­u­lar, En­ta­sis is de­vel­op­ing a com­bo of the drug with an­oth­er β-lac­ta­mase in­hibitor called sul­bac­tam to treat a slate of mul­tidrug-re­sis­tant in­fec­tions caused by Acine­to­bac­ter bau­man­nii, which is par­tic­u­lar­ly preva­lent in Chi­na. The deal, which gives Zai Lab rights to de­vel­op and com­mer­cial­ize the drug in the Asia Pa­cif­ic re­gion, al­so maps out a col­lab­o­ra­tion over a Phase III tri­al in Chi­na, where Shang­hai-based Zai Lab will take charge of pa­tient screen­ing, en­roll­ment and treat­ment. En­ta­sis is in for a to­tal of $7.6 mil­lion in near-term mile­stones and up to $91 mil­lion for meet­ing ad­di­tion­al reg­u­la­to­ry and sales goals.

With con­tri­bu­tion by Am­ber Tong.

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.

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.

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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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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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.

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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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Maze in­ter­im chief Charles Hom­cy pass­es ba­ton to Ja­son Colo­ma; William Col­lier tapped as CEO of Ar­bu­tus

→ Four months in­to Maze Ther­a­peu­tics’ launch, Charles Hom­cy is pass­ing the start­up’s reins to an­oth­er Third Rock col­league. Ja­son Colo­ma, the cur­rent COO, is leav­ing his role at the VC firm to be­come full-time CEO on a mis­sion to trans­late ge­net­ic in­sights in­to new med­i­cines. Equipped with a whop­ping $191 mil­lion with sup­port from Arch, Maze’s big idea is to find and tar­get ge­net­ic mod­i­fiers that play a role in Mendelian dis­eases caused by an­oth­er gene. Colo­ma, a Roche/Genen­tech vet sea­soned in busi­ness de­vel­op­ment, was CBO at Corvus Phar­ma­ceu­ti­cals be­fore join­ing Third Rock in 2017.