Tired of fin­ish­ing in last place, Eli Lil­ly’s new R&D chief wants to shake things up

Dan Skovron­sky. LIL­LY PAD

Bern­stein’s Tim An­der­son has been hold­ing some in-depth dis­cus­sions with the ex­ec­u­tive team at Eli Lil­ly, in­clud­ing Dan Skovron­sky, the in­com­ing head of R&D. And it’s clear that Skovron­sky — who’s tak­ing Jan Lund­berg’s place June 1 — in­tends to get more ag­gres­sive in ear­ly-stage de­vel­op­ment as he works to com­plete­ly shed a well-earned rep­u­ta­tion for a go-slow clin­i­cal ap­proach that has fre­quent­ly put them at the end of a long line of ri­vals.

If you look at some of the most ex­cit­ing tar­gets in our in­dus­try, tar­gets that Lil­ly has worked on, things like CDK 4/6, IL-17, IL-23, PC­SK9, CGRP, in each of these we could eas­i­ly have been first,” Skovron­sky, the for­mer CEO of Avid Ra­dio­phar­ma­ceu­ti­cals, told An­der­son. “Our sci­en­tists were among the first work­ing on these tar­gets in the lab and mak­ing drugs against them. In many cas­es, we were slow get­ting up the courage to move in­to hu­man tri­als for var­i­ous rea­sons. We are look­ing to change that.”

Tim An­der­son

That means launch­ing more Phase I stud­ies, look­ing for ear­ly signs of whether they’re on the right track. Then they can de­cide to move for­ward quick­ly, or kill it in the case of weak da­ta.

“We want to be the first test­ing nov­el mech­a­nisms, so that is one change,” Skovron­sky not­ed. “You should see more Lil­ly Phase I tri­als and proof-of-con­cept tri­als on nov­el mech­a­nisms. An­oth­er change that you can ex­pect is that some­times I think Lil­ly has a rep­u­ta­tion for be­ing a fast fol­low­er or de­vel­op me-too drugs in the past. We do not think that is sus­tain­able for our in­dus­try. We need to be fo­cused on drugs with large ef­fect sizes. I think that is al­ways our in­tent, but we con­tin­ue to ratch­et up the pres­sure here to re­al­ly on­ly move for­ward the drugs that we be­lieve can de­liv­er that kind of large dif­fer­en­ti­at­ed ef­fect for pa­tients.”  

Quick trans­la­tion: Go big or go home. And no more lin­ger­ing.

“That means in Phase II proof-of-con­cept stud­ies you should ex­pect us to test new mech­a­nisms in a small num­ber of pa­tients look­ing for the large ef­fect size. If we do not get it, we will move on to the next mech­a­nism and not try and eke out an OK drug. We can talk about that with Alzheimer’s, di­a­betes and oth­er ar­eas; it is work­ing ob­vi­ous­ly in on­col­o­gy and im­munol­o­gy. So speed and large ef­fect sizes. Then the third thing is con­tin­ued evo­lu­tion on ex­ter­nal in­no­va­tion. In the past, we have been pret­ty good at bring­ing in drugs late in de­vel­op­ment, lots of Phase III part­ner­ships or Phase II af­ter proof of con­cept. I think where we are seek­ing to im­prove is on ear­li­er-stage deals. So we will con­tin­ue to do those late deals, but we al­so want to bring in more nov­el tar­gets, nov­el tech­nolo­gies, nov­el drugs in ear­li­er high­er risk stages of de­vel­op­ment.  Some of the changes we have al­ready an­nounced, for ex­am­ple, mov­ing busi­ness de­vel­op­ment in­to R&D should help fa­cil­i­tate that.  But you should ex­pect to see more of that in the fu­ture.”

Eli Lil­ly is one of the world’s top 15 R&D op­er­a­tors, with a string of new drug ap­provals in the last few years that fol­lowed a long and in­cred­i­bly frus­trat­ing de­vel­op­ment drought. It’s had some big set­backs along the way, in­clud­ing the ini­tial re­jec­tion of baric­i­tinib, now back on track at the FDA. Its painstak­ing progress in the clin­ic has de­liv­ered some im­pres­sive da­ta, but Skovron­sky knows that com­pe­ti­tion among the top play­ers is heat­ing up.

Now he’s signed off on a new mis­sion state­ment to fix what still ails Lil­ly.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

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.

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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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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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.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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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.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

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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