Pro­to­cols: CRO in­dus­try poised for steady growth as new work in Chi­na ex­plodes (in a good way); Vec­tura dinged on PhI­II Flu­ti­form flop

Shares of the UK’s Vec­tura dropped ear­ly Tues­day af­ter the com­pa­ny con­ced­ed that Flu­ti­form had failed a Phase III study for COPD. The failed study, run by Mundipharm, is scut­tling plans for a reg­u­la­to­ry fil­ing.”Whilst this re­sult is dis­ap­point­ing, Flu­ti­form con­tin­ues to grow strong­ly based on the ap­proved asth­ma in­di­ca­tion, which con­tin­ues to un­der­pin our ex­pec­ta­tions for fu­ture growth of the prod­uct,” Chief Ex­ec­u­tive Of­fi­cer James Ward-Lil­ley said.

As ex­pect­ed, Ari­ad Phar­ma­ceu­ti­cals has com­plet­ed its rolling sub­mis­sion for the NDA on its ALK in­hibitor briga­tinib. Ari­ad is shoot­ing for a pri­or­i­ty re­view that would cut the re­view process down to eight months. “We re­main grate­ful to the FDA for grant­i­ng briga­tinib a break­through des­ig­na­tion and the ben­e­fit of a rolling sub­mis­sion process, unique to the U.S. reg­u­la­to­ry sys­tem,” said CEO Paris Panayiotopou­los.

Typ­i­cal­ly long on promis­es and short on per­for­mance, In­ovio Phar­ma­ceu­ti­cals has start­ed an­oth­er clin­i­cal tri­al for its zi­ka vac­cine. CEO Joseph Kim, who’s been crit­i­cized for leap­ing from pan­dem­ic to pan­dem­ic with­out ac­tu­al­ly see­ing any­thing through to an ap­proval, says the com­pa­ny will meet with reg­u­la­tors next year if the study proves promis­ing.

The fu­ture looks good for the CRO in­dus­try. Not great or fan­tas­tic, but a lot bet­ter than it has been ear­li­er in the decade. A new re­port out from KP­MG notes that the in­dus­try ap­pears head­ed for steady growth through 2019, with the largest or­ga­ni­za­tions emerg­ing from a ma­jor round of con­sol­i­da­tion set to out­per­form the hun­dreds of small­er com­pa­nies that still op­er­ate in bio­phar­ma. One of the big trends to look for here is a shift to Chi­na, where CRO work has been ex­plod­ing. The CRO mar­ket was a mod­est $1.4 bil­lion in 2007, but grew to $6.4 bil­lion in ’14. That rapid growth rate un­der­scores the grow­ing role that emerg­ing mar­kets plays in this field, where costs can be con­sid­er­ably low­er. The top 10 CROs dom­i­nate, with a glob­al reach that leaves them with half of the mar­ket. The mas­sive shake­out in the mar­ket over the past few years is al­so blur­ring the line be­tween dis­ci­plines, a strat­e­gy that has helped dri­ve growth in the CRO busi­ness.

Steady but ten­ta­tive growth for CROs, from KP­MG.


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.

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.

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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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.

Green-light­ed in Japan, FDA quick­ly spurns Dai­ichi Sanky­o's flawed ap­pli­ca­tion for AML drug

Three days af­ter win­ning Japan­ese ap­proval for its acute myeloid leukemia drug quizar­tinib, Dai­ichi Sankyo is be­ing forced to en­dure an em­bar­rass­ing re­jec­tion at the hands of the FDA.

US reg­u­la­tors wast­ed no time in bat­ting back quizar­tinib af­ter first high­light­ing the messy da­ta in its ap­pli­ca­tion in an in­ter­nal re­view, that in turn per­suad­ed a large ma­jor­i­ty of out­side ex­perts to rec­om­mend a re­jec­tion for the drug, which tar­gets FLT3-ITD–pos­i­tive AML cas­es.

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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HIV, pneu­mo­coc­cal — and what? Mer­ck­'s un­ex­pect­ed pipeline high­light ex­cites a lit­tle biotech

In an R&D update dominated by oncology — mostly Keytruda, followed by Lynparza and Lenvima — Merck chose to highlight a program in sensory pathology, an HIV drug, and a group of pneumococcal vaccines. And that has made at least one biotech very happy.

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