Af­ter bumpy 2017, Cel­gene CEO says tak­ing risk is the on­ly way for­ward

Mark Alles

SAN FRAN­CIS­CO — Cel­gene’s CEO Mark Alles kicked off JPM this morn­ing re­as­sur­ing in­vestors that bets on new­ly-ac­quired as­sets will keep the com­pa­ny’s mo­men­tum strong — de­spite a rocky 2017.

Still, the com­pa­ny’s stock $CELG is down 2.9% fol­low­ing the pre­sen­ta­tion, like­ly due to the an­nu­al rev­enue fore­cast for 2018, which came in slight­ly un­der Wall Street’s ex­pec­ta­tions at $14.4 bil­lion to $14.8 bil­lion. The av­er­age es­ti­mate from an­a­lysts was $14.83 bil­lion.

The com­pa­ny’s big JPM news got spilled yes­ter­day by the Wall Street Jour­nal, which first re­port­ed Cel­gene’s $7 bil­lion buy of San Diego start­up Im­pact Bio­med­i­cines (the deal was large­ly in biobucks, with $1.1 bil­lion up­front). The deal, WSJ’s sources said, was sup­posed to be an­nounced this morn­ing.

Alles didn’t men­tion the Phase III flop of mon­gersen, the biotech’s most ad­vanced ex­per­i­men­tal drug in its in­flam­ma­tion and im­munol­o­gy pipeline (where the com­pa­ny had high hopes for block­buster break­outs). The drug failed its late-stage study in Crohn’s back in Oc­to­ber, and now the com­pa­ny is fo­cus­ing hard on its pipeline of hope­fuls.

All eyes are on ozan­i­mod, ac­quired in the buy­out of Re­cep­tos back in 2015, and the new as­set Cel­gene is pick­ing up from Im­pact.

“The Re­cep­tos trans­ac­tion with ozan­i­mod is a very present event for us, and we rec­og­nize that the risk we have to take to build the com­pa­ny — by do­ing things like the Re­cep­tos trans­ac­tion in 2015 — plays out over time and now we have a multi­bil­lion block­buster on our hands,” Alles said dur­ing the pre­sen­ta­tion.

As we re­port­ed yes­ter­day, Im­pact’s JAK2 myelofi­bro­sis drug fe­dra­tinib was a Sanofi cast-off re­cent­ly res­ur­rect­ed by John Hood, the for­mer co-founder and CSO of San Diego’s re­gen­er­a­tive med­i­cine com­pa­ny Sa­mumed. Hood was shoot­ing for a quick turn­around at the FDA, look­ing to lever­age the ex­ist­ing piv­otal da­ta with new safe­ty in­fo to set up a quick ap­proval. Cel­gene will now be hus­tling ahead with that plan in place.

But all the em­pha­sis on the pipeline may not ease in­vestors’ con­cerns. Af­ter earn­ing a long­stand­ing rep­u­ta­tion as an in­dus­try dar­ling for its mas­sive growth over the years, Cel­gene’s rough last half of 2017 spooked in­vestors. Af­ter mon­gersen’s flop, Cel­gene al­so cut its guid­ance for 2020.

It’s pos­si­ble that in­vestors aren’t too as­sured with the Im­pact ac­qui­si­tion, as fe­dra­tinib is a me-too drug in a cat­e­go­ry where there’s al­ready sol­id com­pe­ti­tion.

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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