Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

Glax­o­SmithK­line’s Benlysta isn’t alone in the small cir­cle of ap­proved lu­pus nephri­tis drugs any­more.

Lit­tle Au­rinia Phar­ma­ceu­ti­cals has got­ten the green light from the FDA to start mar­ket­ing its first and on­ly pro­gram, vo­closporin, un­der the brand name Lup­ky­nis — some­thing CEO Pe­ter Green­leaf says it’s been ready to do since De­cem­ber.

Reg­u­la­tors went right down to the wire on the de­ci­sion, keep­ing the com­pa­ny and the en­tire sales­force it’s al­ready as­sem­bled on its toes.

Pe­ter Green­leaf

But they haven’t been idle. In an ear­li­er in­ter­view, Green­leaf told End­points News that the field team, which to­tals about 100 to 150 sales reps, has al­ready start­ed talk­ing to physi­cians about LN and go­ing to med­ical meet­ings to present da­ta on vo­closporin. By block­ing cal­cineurin, a sig­nal­ing pro­tein in­volved in T cell ac­ti­va­tion, the small mol­e­cule oral drug is de­signed to in­hib­it IL-2 and tamps down in­flam­ma­tion in the kid­ney.

The Phase III tri­al, AU­RO­RA, vo­closporin plus my­cophe­no­late mofetil and low-dose cor­ti­cos­teroids hit the pri­ma­ry end­point on re­nal re­sponse at 1-year. It al­so hit the bar for get­ting pro­tein­uria, a mea­sure­ment of ac­tive dis­ease, un­der con­trol.

“I mean, that’s the num­ber 1 treat­ment goal that physi­cians search for,” Green­leaf said.

First an­nounced in late 2019, those re­sults were sev­en years in the mak­ing for CMO Neil Solomons, who was part of a team at Vi­for Phar­ma that brought in vo­closporin from Isotech­ni­ka — it was be­ing de­vel­oped for kid­ney trans­plant re­jec­tion at that time — and spun out Au­rinia. Even though a pre­vi­ous study he was in­volved in had ce­ment­ed my­cophe­no­late mofetil, or MMF, among oth­er un­ap­proved meds as the stan­dard of care, there was re­al­ly no di­rect ev­i­dence of their treat­ment ef­fect (They were al­so “high­ly tox­ic,” ac­cord­ing to a tri­al in­ves­ti­ga­tor.)

Neil Solomons

“We’re the first com­pa­ny to do that,” Solomons said, “ran­dom­ized blind­ed con­trolled study with our Phase II tri­al back in 2016 to ac­tu­al­ly demon­strate that the drug ac­tu­al­ly tru­ly works in this area.“

Al­so among the firsts: a patent­ed dos­ing pro­to­col that al­lows pa­tients to titrate down the dose based on an es­ti­mate of re­nal func­tion known as eGFR, and re­duc­tion of cor­ti­cos­teroids re­quired in the reg­i­men.

All of those qual­i­ties, the com­pa­ny reck­ons, could give its reps plen­ty to con­vince doc­tors to take on their drug.

Green­leaf added that vo­closporin “works very very rapid­ly,” show­ing ben­e­fit at both the 6-month and 1-year time points that seems com­pa­ra­ble to — with the usu­al caveats about cross-tri­al com­par­isons — what Benlysta, a bi­o­log­ic, showed at 2 years.

“Who knows what that means for fu­ture treat­ment — how they’re used along­side of each oth­er, in con­cert or with­in the full treat­ment con­tin­u­um,” the CEO, who’s run a trio of oth­er biotechs af­ter leav­ing As­traZeneca’s Med­Im­mune, said. “But to­day as it ex­ists we think our drug stands very well on its own.”

By their count, the LN pa­tient pop­u­la­tion in the US is well north of 100,000. With $400 mil­lion in cash, Au­rinia’s $AUPH com­mer­cial team will have am­ple fund­ing for sev­er­al years. Ot­su­ka, its new part­ner, is tasked with scor­ing OKs and com­mer­cial­iz­ing in the EU, Japan and else­where.

Joseph Schwartz of SVB Leerink is a be­liev­er. While GSK may have the up­per hand at launch, he wrote, vo­closporin should even­tu­al­ly “come out on top, as it has su­pe­ri­or ef­fi­ca­cy as com­pared to Benlysta”: Au­rinia re­port­ed a re­nal re­sponse rate of 40.8% ver­sus 22.5% in the con­trol arm while Benlysta’s dif­fer­ence with con­trol was small­er (43% vs 32%).

For 2021, he’s mod­el­ing US sales at $87.6 mil­lion as­sum­ing a price of $35,000.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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