Trou­bled In­fin­i­ty ax­es 100 staffers, shut­ters tri­als and re­wards top ex­ecs af­ter Ab­b­Vie walks away from deal

Back in the fall of 2014, a rest­less Ab­b­Vie stepped in with a $275 mil­lion up­front pay­ment to part­ner with In­fin­i­ty Phar­ma­ceu­ti­cals on du­velis­ib, its oral PI3k-delta/gam­ma in­hibitor for blood can­cers. To­day, af­ter du­velis­ib failed to im­press the phar­ma com­pa­ny in a mid-stage study, Ab­b­Vie is walk­ing away from their part­ner­ship and In­fin­i­ty is ax­ing 100 staffers to con­serve cash.

In­fin­i­ty’s trou­bles hit af­ter du­velis­ib hit its pri­ma­ry end­point for in­do­lent non-Hodgkin lym­phoma in a Phase II with a 46% over­all re­sponse rate. Zy­delig and Rit­ux­an both did bet­ter than that, though, spurring some big ques­tions over what kind of fu­ture the drug could have on the mar­ket.

Ab­b­Vie im­me­di­ate­ly sus­pend­ed a com­bi­na­tion study with vene­to­clax, and now In­fin­i­ty says the study is be­ing ter­mi­nat­ed. The biotech is al­so clos­ing BRAVU­RA, a Phase III study of du­velis­ib in pa­tients with re­lapsed iNHL, and CON­TEM­PO, a Phase Ib/2 study of du­velis­ib in treat­ment-naïve pa­tients with fol­lic­u­lar lym­phoma.

But the Cam­bridge, MA-based biotech is not giv­ing up on du­velis­ib. Nei­ther are the ex­ec­u­tives who are pur­su­ing a ques­tion­able strat­e­gy in con­tin­u­ing to try and blaze a path to the FDA.

In an 8-K filed with the SEC, In­fin­i­ty laid out a se­ries of 6-fig­ure re­ten­tion bonus­es for CEO Ade­lene Perkins, R&D chief Ju­lian Adams along with the CFO and chief com­mer­cial of­fi­cers. Perkins is in line for $334,750; Adams gets $249,000; Lawrence Bloch gets $209,000 and Su­jay Kan­go gets $205,000. That’s half of their base pay.

The news kicked up a fuss on Twit­ter, though TheStreet’s Adam Feuer­stein lat­er re­port­ed all re­main­ing staffers at the biotech are in line for a 50% re­ten­tion bonus.

Ade­lene Perkins, In­fin­i­ty CEO

A spokesper­son for In­fin­i­ty broke it down like this for End­points: “The num­ber of peo­ple el­i­gi­ble for a re­ten­tion bonus is 79 (65 re­main­ing plus 14 of the 100 im­pact­ed who are stay­ing past la­bor day but con­clud­ing work by 12/30).  Each of those em­ploy­ees gets a bonus up to 50% but it’s on a pro-rat­ed ba­sis.  The pay­ment dates are 12/30/16 and 7/1/17.

“Ex­am­ple:  If you make 100K, and work un­til De­cem­ber 30th, you get 25K.  If you were to work un­til Ju­ly 1, 2017, you would get an­oth­er 25K.  If you were to be ter­mi­nat­ed Sept 30th, you get $12,500K (pro-rat­ed with start date of re­ten­tion pro­gram be­ing Ju­ly 1 of this year).”

In a state­ment, Perkins says the com­pa­ny plans to pur­sue an ap­proval with the FDA, mix­ing its Phase II da­ta with re­sults from an on­go­ing Phase III in search of an ac­cel­er­at­ed ap­proval. Topline da­ta is ex­pect­ed from the Phase III in the next few months. And if that flies with reg­u­la­tors they’ll turn to their FRES­CO study to serve as a con­fir­ma­to­ry study for full ap­proval in fol­lic­u­lar lym­phoma.

“Da­ta re­port­ed to date have demon­strat­ed that du­velis­ib is clin­i­cal­ly ac­tive with a man­age­able safe­ty pro­file, and we be­lieve that it could play an im­por­tant role in the fu­ture treat­ment of pa­tients with hema­to­log­ic ma­lig­nan­cies, par­tic­u­lar­ly for re­laps­ing and/or re­frac­to­ry pa­tients,” Perkins not­ed. We are now ex­plor­ing strate­gic op­tions for the pro­gram that could en­able the sub­mis­sion of glob­al reg­u­la­to­ry ap­pli­ca­tions and com­mer­cial­iza­tion for du­velis­ib.”

Wed­bush an­a­lyst David Nieren­garten wasn’t sur­prised by Ab­b­Vie’s ex­it. But with In­fin­i­ty al­so shift­ing fo­cus to an ear­ly-stage drug in the pipeline, it’s go­ing to face an­oth­er up­hill strug­gle to gain con­vinc­ing da­ta in a very com­pet­i­tive field.

“IPI-549 is a PI3K-gam­ma in­hibitor cur­rent­ly in Ph 1 study as monother­a­py and in com­bi­na­tion with an an­ti-PD1 an­ti­body,” he says. “IN­FI has shown pre­clin­i­cal­ly that com­bi­na­tion of IPI-549 with check­point in­hibitors re­sults in syn­er­gis­tic an­ti-tu­mor ac­tiv­i­ty in mouse mod­els. How­ev­er, giv­en the large num­ber of on­go­ing check­point in­hibitor com­bi­na­tion tri­als, we would ex­pect IPI-549 to have to demon­strate com­pelling ac­tiv­i­ty to gen­er­ate sig­nif­i­cant in­vestor in­ter­est. With sig­nif­i­cant cost re­duc­tions not ex­pect­ed un­til 2017, we mod­el for YE cash to be ap­prox­i­mate­ly $58M.”

This is Perkins’ third ma­jor cri­sis at In­fin­i­ty, fol­low­ing the fail­ure of two ear­li­er lead pro­grams in can­cer. Whether it can sur­vive this one, though, is still un­cer­tain.

 

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.

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.

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.

J&J's Es­ke­t­a­mine, at cur­rent price, is 'low val­ue for mon­ey' — ICER

For John­son & John­son’s $JNJ phar­ma­ceu­ti­cal ver­sion of the hal­lu­cino­genic anes­thet­ic ke­t­a­mine — es­ke­t­a­mine — to be cost-ef­fec­tive for use in treat­ment-re­sis­tant de­pres­sion in the long term, its list price must be cut by up to half, ICER con­clud­ed in its fi­nal re­port on Thurs­day.

Cog­nizant of the myr­i­ad of ap­proved an­ti­de­pres­sants that of­ten don’t work, the US reg­u­la­tor en­dorsed J&J’s es­ke­t­a­mine, brand­ed as  — Spra­va­to — in March for treat­ment-re­sis­tant de­pres­sion, con­scious that the orig­i­nal cat tran­quil­iz­er is fre­quent­ly used off-la­bel for se­vere de­pres­sion.

In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

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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