Atara en­lists Juno co-founder Michel Sade­lain in CAR-T ef­fort; Valeant no more, Bausch is the new mar­quee name

Michel Sade­lain

→ The day af­ter Atara an­nounced that it is bring­ing Genen­tech vet Di­et­mar Berg­er on board as R&D chief, the biotech is back with a signed deal aimed at ex­pand­ing its work with Memo­r­i­al Sloan Ket­ter­ing on off-the-shelf CAR-Ts. As part of that arrange­ment, Atara is get­ting an ex­clu­sive re­la­tion­ship with Michel Sade­lain, the top CAR-T in­ves­ti­ga­tor who helped cre­ate the sci­en­tif­ic foun­da­tion for Juno. Said Sade­lain: “We are ea­ger to work with Atara to con­tin­ue ad­vanc­ing promis­ing al­lo­gene­ic T-cell im­munother­a­py tech­nolo­gies that orig­i­nat­ed at MSK. The new CAR T tech­nolo­gies seek to over­come per­sis­tent ther­a­peu­tic chal­lenges, such as safe­ty and tol­er­a­bil­i­ty, dura­bil­i­ty of treat­ment re­sponse, and ac­tiv­i­ty in ar­eas of sig­nif­i­cant un­met med­ical need that are un­der­served by the cur­rent gen­er­a­tion of CAR T im­munother­a­pies.”

→ Af­ter be­ing pum­meled with bad pub­lic­i­ty for its dis­as­trous cor­po­rate strate­gies, Valeant is throw­ing out its old name in fa­vor of some­thing with con­sid­er­ably less bag­gage. You can now call the com­pa­ny Bausch Health Com­pa­nies, says CEO Joe Pa­pa. Adds Pa­pa: “We be­lieve Bausch Health Com­pa­nies more ac­cu­rate­ly rep­re­sents the full scope of the Com­pa­ny to­day – a leader in the de­vel­op­ment and man­u­fac­ture of a wide range of phar­ma­ceu­ti­cal, med­ical de­vice and over-the-counter prod­ucts, pri­mar­i­ly in the ther­a­peu­tic ar­eas of eye health, gas­troen­terol­o­gy and der­ma­tol­ogy.” The re­brand­ed com­pa­ny will trade un­der the stock tick­er $BHC in­stead of $VRX.

As­traZeneca is sell­ing off more drug rights for some quick cash. In this in­stance, the phar­ma gi­ant is sell­ing rights to Sero­quel in a num­ber of mar­ket, in­clud­ing the UK and Chi­na. And it’s get­ting $260 mil­lion now from Luye Phar­ma as part of a $538 mil­lion deal.

Spark Ther­a­peu­tics’ Q1 re­port in­clud­ed news that its pi­o­neer­ing gene ther­a­py Lux­tur­na has been used on three pa­tients in the roll­out. CEO Jef­frey Mar­raz­zo $ONCE says he is en­cour­aged by the ini­tial de­mand.

→ The mR­NA biotech Cure­Vac is see­ing a change­up at the top. CEO In­g­mar Ho­err plans to tran­si­tion up to the chair­man’s job while Daniel Menichel­la moves in­to the CEO suite.

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.