Shire gains a de­layed FDA OK for ‘block­buster’ dry eye drug li­fite­grast

Nine months af­ter the FDA hand­ed Shire $SH­PG a re­jec­tion for its dry eye drug li­fite­grast, the biotech com­pa­ny says it’s bounced back with a de­layed ap­proval from the FDA. And now Shire will set out to see if it can achieve its ear­li­er fore­cast of more than a bil­lion dol­lars in an­nu­al sales.

Shire will be tack­ling a broad mar­ket in­clud­ing more than 16 mil­lion peo­ple who have been di­ag­nosed with dry eye dis­ease. The com­pa­ny plans to get start­ed mar­ket­ing the eye drop ther­a­py in a few months, sell­ing it as Xi­idra.

Flem­ming Orn­skov, CEO of Shire

The ap­proval marks a clear win for CEO Flem­ming Orn­skov, who brought a de­sire to de­vel­op a pipeline of new oph­thalmic drugs when he took the helm at Shire, based in Dublin with an R&D heart cen­tered in Lex­ing­ton, MA. And the mar­ket loved the news, send­ing Shire share up 5%.

Orn­skov made li­fite­grast a key part of his plan to grow sales to $10 bil­lion a year, ahead of his big ac­qui­si­tion of Bax­al­ta. And he’s had some ups and downs along the way.

This ap­proval, though, marks a sig­nal step ahead for the com­pa­ny, if the drug per­forms on the mar­ket. Once the sub­ject of an Ab­b­Vie takeover at­tempt, which was scut­tled by new fed­er­al rules de­signed to de­rail tax in­ver­sions, Orn­skov has re­mained com­mit­ted to mak­ing Shire in­to a glob­al bio­phar­ma force to be reck­oned with.

In this case, Shire will have to con­tend with Brent Saun­ders and Al­ler­gan, which earned more than a bil­lion dol­lars last year for the lead­ing dry eye treat­ment on the mar­ket, Resta­sis (cy­closporin). The bulk of that mon­ey came from the big U.S. mar­ket.

“As Shire’s first FDA-ap­proved med­i­cine in oph­thalmics, this sig­nif­i­cant mile­stone ad­vances our goal of be­com­ing the glob­al leader in this cat­e­go­ry, where there are un­met pa­tient needs,” Orn­skov said in a state­ment. “We have a ro­bust oph­thalmics pipeline, and we look for­ward to lever­ag­ing Xi­idra as our en­trée in­to the space as we con­tin­ue to de­vel­op ad­di­tion­al in­no­v­a­tive eye care treat­ment op­tions.”

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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