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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.