CEO Todd Zavodnick (Dermavant)

With long-term da­ta in hand, Vivek Ra­maswamy's Der­ma­vant team dash­es to the goal line with top­i­cal pso­ri­a­sis con­tender

Months af­ter tout­ing pos­i­tive da­ta from two piv­otal Phase II­Is, Vivek Ra­maswamy’s Der­ma­vant team is back with long-term da­ta to back its pso­ri­a­sis can­di­date tap­inarof — and it’s head­ed for the FDA.

About 91% of the 1,025 pa­tients in Der­ma­vant’s PSOAR­ING 1 and 2 Phase III stud­ies opt­ed to roll in­to PSOAR­ING 3, a long-term safe­ty analy­sis, CEO Todd Za­vod­nick said. But the study end­ed up be­ing much more than a safe­ty tri­al.

“It re­al­ly al­lowed us to con­firm trends, and a hy­poth­e­sis that we formed in ear­li­er tri­als around our ef­fi­ca­cy, dura­bil­i­ty, and then our re­mit­tance,” Za­vod­nick said.

While pa­tients in PSOAR­ING 1 and 2 were fol­lowed for 12 weeks, an in­ter­im analy­sis of PSOAR­ING 3 showed im­prove­ments be­yond Week 12, ac­cord­ing to Der­ma­vant. No new safe­ty sig­nals were seen over the 52 weeks, and 57.3% of pa­tients who en­tered the study with a Physi­cian Glob­al As­sess­ment (PGA) score of 2 or high­er end­ed up with a PGA score of 0 or 1, the com­pa­ny an­nounced.

Pa­tients’ symp­toms didn’t flare back up for a me­di­an of four months, Za­vod­nick added.

Der­ma­vant al­so con­duct­ed an in­te­grat­ed ef­fi­ca­cy analy­sis with da­ta from PSOAR­ING 1 and 2, and the in­ter­im da­ta from PSOAR­ING 3. They found that PASI-75 — a 75% re­duc­tion in Pso­ri­a­sis Area and Sever­i­ty In­dex score — was achieved by 63.5% of pa­tients. PASI-90, at any time point, was achieved by 44.2% of pa­tients.

“In our piv­otal tri­als, in the Phase III piv­otals as well as in the Phase IIb tri­als, we saw glimpses of dura­bil­i­ty and re­mit­tance … Pa­tients were get­ting bet­ter on the drug, and there was no tachy­phy­lax­is with the drug. But we want­ed to con­firm it,” Za­vod­nick said.

The com­pa­ny plans on fil­ing an NDA in the first half of this year.

Tap­inarof is a once-dai­ly, “cos­met­i­cal­ly el­e­gant” van­ish­ing cream, which Ra­maswamy plucked from GSK for $330 mil­lion — $200 mil­lion up­front. Za­vod­nick is lin­ing it up to re­place steroids in the top­i­cal space. The most se­vere pso­ri­a­sis pa­tients can grad­u­ate to ul­tra-ef­fec­tive bi­o­log­ics, he says, where he still sees a role for the cream as an add-on ther­a­py.

“Pa­tients that have se­vere … large body sur­face ar­eas of im­pact, they’re still go­ing to get orals and they’re still go­ing to get in­jecta­bles. But they’re go­ing to be get­ting an ac­com­pa­nied non­s­teroidal top­i­cal that they could use for as long as they want. And I think that’s the beau­ty of non­s­teroidals. There’s no lim­it to us­age, where with steroids, they’re lim­it­ed,” Za­vod­nick said.

With plans to ini­ti­ate a Phase III tri­al in atopic der­mati­tis this year, Za­vod­nick says tap­inarof could be the foun­da­tion on which Der­ma­vant builds a “multi­bil­lion-dol­lar or­ga­ni­za­tion.” It’s a tall or­der — but the com­pa­ny wouldn’t be a “Vant” if it didn’t promise big things at a fast pace. Ra­maswamy, who found­ed Roivant on the idea that he could pol­ish drugs off the Big Phar­ma dis­card lane, an­nounced ear­li­er this year that he’s step­ping back to de­vote more time to the po­lit­i­cal sphere.

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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