Eli Lil­ly of­fers $400M-plus deal to bag an ear­ly-stage au­toim­mune drug from Nek­tar

With lit­tle more than pre­clin­i­cal da­ta and some ini­tial dos­ing co­hort in­sights avail­able for re­view, Eli Lil­ly is mak­ing a $400 mil­lion-plus play to buy in­to an ear­ly-stage au­toim­mune drug at Nek­tar $NK­TR that the phar­ma gi­ant be­lieves has megablock­buster po­ten­tial.

Dave Ricks, Eli Lil­ly CEO

Eli Lil­ly $LLY has agreed to ac­quire co-de­vel­op­ment rights on NK­TR-358 — which was first dosed in a hu­man in a Phase I study 4 months ago — for $150 mil­lion up front plus $250 mil­lion in mile­stones. Lil­ly will pick up 75% of the Phase II de­vel­op­ment costs and Nek­tar will have the opt-in rights on this drug on an in­di­ca­tion-by-in­di­ca­tion ba­sis.

The drug is de­signed to ac­ti­vate reg­u­la­to­ry T cells by tar­get­ing IL-2, an ap­proach Lil­ly and Nek­tar be­lieve could put the im­mune sys­tem back on track in fix­ing au­toim­mune dis­eases.

Nek­tar CEO Howard Robin, who is in no way re­luc­tant to talk up the prospects of the drugs the biotech has in the clin­ic, cit­ed this drug for its unique qual­i­ties in the Q1 call back in April. Here’s what he had to say:

Un­like cur­rent im­muno­sup­pres­sant agents, which glob­al­ly weak­en the im­mune sys­tem to on­ly ad­dress dis­ease symp­toms. NK­TR-358 is a first-in-class res­o­lu­tion ther­a­peu­tic de­signed to specif­i­cal­ly cor­rect the un­der­ly­ing pathol­o­gy of au­toim­mune dis­ease. NK­TR-358 is the on­ly med­i­cine of its kind in clin­i­cal tri­als. It has the po­ten­tial to have a pro­found ef­fect on a num­ber of im­mune and in­flam­ma­to­ry dis­or­ders, in­clud­ing lu­pus, IBD, RA, pso­ri­a­sis, MS, Type 1 di­a­betes and even al­ler­gy.

With an as­set that has this much broad po­ten­tial in so many in­di­ca­tions, we be­lieve the right strat­e­gy for NK­TR-358 is to seek a co-de­vel­op­ment and co-pro­mo­tion part­ner­ship with a com­pa­ny that has a strong lead­er­ship po­si­tion in im­munol­o­gy and im­por­tant­ly shares our vi­sion for the broad de­vel­op­ment of NK­TR-358. Our goal is to en­ter in­to part­ner­ship this year.

Nek­tar pre­clin­i­cal R&D chief Jonathan Za­levsky, who’s cred­it­ed as the in­ven­tor, added:

Un­like cur­rent im­muno­sup­pres­sant agents, which glob­al­ly weak­en the im­mune sys­tem to on­ly ad­dress dis­ease symp­toms. NK­TR-358 is a first-in-class res­o­lu­tion ther­a­peu­tic de­signed to specif­i­cal­ly cor­rect the un­der­ly­ing pathol­o­gy of au­toim­mune dis­ease. NK­TR-358 is the on­ly med­i­cine of its kind in clin­i­cal tri­als. It has the po­ten­tial to have a pro­found ef­fect on a num­ber of im­mune and in­flam­ma­to­ry dis­or­ders, in­clud­ing lu­pus, IBD, RA, pso­ri­a­sis, MS, Type 1 di­a­betes and even al­ler­gy.

He went on to say that this is the kind of drug that can be self-ad­min­is­tered.

That’s the kind of pro­file that Lil­ly — a ma­jor play­er in di­a­betes — finds at­trac­tive. It’s al­so the kind of big ear­ly-stage deal that for­mer CEO John Lech­leit­er was large­ly un­will­ing to pur­sue. New CEO Dave Ricks, though, has proven ea­ger to add more drugs to the pipeline af­ter a string of new drug ap­provals capped by a big set­back with the FDA’s re­jec­tion of baric­i­tinib.

Nek­tar’s Robin has been wheel­ing and deal­ing over the last few months. The com­pa­ny’s IL-2 re­search has spawned im­muno-on­col­o­gy pro­grams as well as a Take­da part­ner­ship in March. That fol­lowed a com­bo deal with Bris­tol-My­ers Squibb last fall. And af­ter adding Phase III da­ta on its abuse-re­sis­tant opi­oid NK­TR-181 just days ago, Robin re­vived talk of a Big Phar­ma part­ner­ship there as well. Nek­tar, though, al­so just ran in­to a set­back af­ter Eu­ro­pean ex­perts snubbed its pitch for an ear­ly OK on its can­cer drug Onzeald (NK­TR-102).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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As drug­mak­ers spend $6B an­nu­al­ly on DTC ads, sen­a­tors re­vive bill to in­clude list prices in ads

A new GAO report on biopharma companies’ $6 billion annual spending on direct-to-consumer advertising is pushing US Senate Majority Whip Dick Durbin (D-IL) and Sen. Chuck Grassley (R-IA) to reintroduce legislation that would require price disclosures in the ads.

The GAO found that drugmakers spent almost half—$8.2 billion of the $17.8 billion from 2016 to 2018—on DTC ads for drugs in three therapeutic categories, including inflammatory conditions (e.g., arthritis, gout), endocrine and metabolic disorders (e.g., type 2 diabetes, hypothyroidism), and conditions affecting the central nervous system (e.g., depression, multiple sclerosis), according to the new report.

Med­ic­aid com­mis­sion to Con­gress: In­crease re­bates for ac­cel­er­at­ed ap­proval drugs

As the FDA continues to approve more new drugs under its accelerated approval pathway, the non-partisan Medicaid and CHIP Payment and Access Commission (MACPAC) is telling Congress to increase the statutory Medicaid rebates for such drugs until their clinical benefits have been verified.

Higher rebates for drugs with accelerated approvals, a move opposed by the biopharma industry, would mean lower net prices, lessening their financial burden on the health care system while incentivizing the companies to speed the verification of the drugs’ clinical benefits in confirmatory trials. Once those benefits are confirmed, the companies would return to the lower rebates when the accelerated approval is converted into a full approval, MACPAC suggests.

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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