Eight years af­ter Eli Lil­ly dumped it, an up­start biotech has nabbed teplizum­ab and filed a $56M IPO to back a PhI­II come­back

Eight years ago, a drug called teplizum­ab went down in flames af­ter it failed in a piv­otal di­a­betes study un­der­tak­en by Eli Lil­ly. But yes­ter­day a lit­tle start­up called Proven­tion Bio in-li­censed it from Macro­Gen­ics, the orig­i­nal de­vel­op­er, whipped around and to­day used it as their lead drug for a $56 mil­lion IPO fil­ing.

Teplizum­ab wasn’t com­plete­ly dead back in 2010 when Lil­ly dumped the whole thing. But it came aw­ful­ly close to that.

Jef­frey Blue­stone

Jef­frey Blue­stone, a high-pro­file sci­en­tist at UCSF who had worked long and hard on the drug, nev­er lost faith over 30 years of la­bor­ing on it. He con­tin­ued to pur­sue hu­man stud­ies for the drug, watch­ing large groups of di­a­bet­ics re­spond fa­vor­ably to the drug, but weary­ing at times at the task of try­ing to get some re­al mon­ey to back a come­back ef­fort. We ex­changed sev­er­al mes­sages about this drug a cou­ple of years ago as Blue­stone — now run­ning the Park­er In­sti­tute — pushed ahead.

The drug has shown val­ue in pre­serv­ing be­ta cells in the pan­creas, re­duc­ing the need for in­sulin among Type 1 pa­tients. And that’s where it will be test­ed in Phase III, with the study planned to launch next year.

“I am very ex­cit­ed about the “re­vival” of Teplizum­ab,” Blue­stone tells me in an email. “My col­leagues and I have al­ways felt that the drug could be im­pact­ful for re­cent on­set pa­tients with Type 1 Di­a­betes and more­over oth­er au­toim­mune dis­eases. The suc­cess in mul­ti­ple Phase II tri­als con­duct­ed by the aca­d­e­m­ic com­mu­ni­ty gives me great hope for the po­ten­tial for this drug to have an im­pact in a sig­nif­i­cant per­cent­age of these pa­tients. On­ward and up­ward.”

Ash­leigh Palmer

Proven­tion has been work­ing off of a $28 mil­lion A round it nabbed a year ago. That’s not much. And the plans call for on­ly a slice of it to be used to set up the Phase III. Proven­tion al­so has PRV-6527 (the CSF-1R in­hibitor JNJ-40346527, ob­tained from J&J) for Crohn’s dis­ease, and the ul­cer­a­tive col­i­tis can­di­date JNJ-42915925 (PRV-300), an an­ti-TLR3 an­ti­body.

The S-1 spells out all its li­cens­ing deals, in­clud­ing the $42.5 mil­lion it will owe Macro­Gen­ics based up­on “the achieve­ment of cer­tain de­vel­op­men­tal and ap­proval mile­stones for the first in­di­ca­tion, and an ad­di­tion­al $22.5 mil­lion up­on the achieve­ment of cer­tain reg­u­la­to­ry ap­provals for a sec­ond in­di­ca­tion. In ad­di­tion, we are ob­lig­at­ed to make con­tin­gent mile­stone pay­ments to Macro­Gen­ics to­tal­ing $225 mil­lion…” for sales mile­stones.

J&J al­so has a buy-back pro­vi­sion on PRV-6527, giv­ing them the right to claw it back for $50 mil­lion af­ter the next study.

The de­vel­op­ment of teplizum­ab will now lie pri­mar­i­ly in the hands of Ash­leigh Palmer, the CEO at Proven­tion who owns 12.2% of the com­pa­ny, and Fran­cis­co Leon, a J&J vet who once ran ear­ly-stage de­vel­op­ment work for J&J in im­munol­o­gy who al­so owns 12.2% of the com­pa­ny. Macro­Gen­ics now owns 10% of the com­pa­ny and J&J In­no­va­tion is a backer with 11.2%. MDB owns 10.8%.

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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