Miki Kapoor

Re­al-world da­ta get re­al dol­lars: GV, Bain help in­fuse $100M in­to Ve­r­ana Health as prag­mat­ic tri­al space heats up

As the ap­pli­ca­tion of re­al-world da­ta in clin­i­cal prac­tice and drug de­vel­op­ment be­comes the re­al­i­ty for a grow­ing num­ber of physi­cians as well as drug­mak­ers, GV and a mar­quee syn­di­cate are bet­ting some re­al dol­lars on one San Fran­cis­co play­er.

The crew for­mer­ly known as Google Ven­tures is lead­ing a $100 mil­lion round for Ve­r­ana Health, which has just ac­quired a small­er com­pa­ny spe­cial­iz­ing in large-scale da­ta ar­chi­tec­ture so­lu­tions dubbed PYA An­a­lyt­ics. Bain Cap­i­tal Ven­tures, Cas­din Cap­i­tal and De­fine Ven­tures al­so chipped in.

Ve­r­ana be­gan two years ago fo­cused on two big dis­ease ar­eas: oph­thal­mol­o­gy and neu­rol­o­gy. Part­ner­ing with the Amer­i­can Acad­e­my of Oph­thal­mol­o­gy and the Amer­i­can Acad­e­my of Neu­rol­o­gy, the com­pa­ny agrees to foot the bill for their reg­istries — where physi­cians can both re­search de-iden­ti­fied elec­tron­ic health records da­ta and re­port their own ob­ser­va­tions — in ex­change for ac­cess to the datasets.

“Our dif­fer­en­tia­tor is our close col­lab­o­ra­tion with med­ical as­so­ci­a­tions and physi­cians — and our fo­cus on da­ta depth and our ex­per­tise in spe­cial­ty ar­eas,” CEO Mi­ki Kapoor told End­points News. “When we go deep on a dataset, we’re talk­ing about 70% of the coun­try’s records in oph­thal­mol­o­gy, for ex­am­ple.”

As med­ical record shar­ing pacts be­tween hos­pi­tal net­works and tech gi­ants come un­der scruti­ny, it al­so helps that Ve­r­ana is work­ing with au­thor­i­ta­tive, trust­ed stew­ards of da­ta.

The new fi­nanc­ing al­lows them to ex­pand in­to new ther­a­peu­tic cat­e­gories and in­te­grate imag­ing, ge­nomics and claims da­ta sources, Ve­r­ana said, with new da­ta analy­sis and link­ing ca­pa­bil­i­ties from the PYAA team. Ve­r­ana has al­so signed on with a third large med­ical reg­istry, Kapoor said.

Cur­rent­ly, these da­ta are locked in sep­a­rate repos­i­to­ries, he added, cre­at­ing a kind of siloed in­for­ma­tion sys­tems that have been fre­quent­ly crit­i­cized by oth­ers work­ing on re­al-world ev­i­dence.

While Ve­r­ana bills it­self as a “provider-fo­cused” op­er­a­tion — with ser­vices help­ing doc­tors see ag­gre­gat­ed prac­tice trends and learn about clin­i­cal tri­als — Kr­ish­na Yesh­want, gen­er­al part­ner at GV, not­ed its po­ten­tial to “un­lock deep clin­i­cal in­sights that sup­port the de­vel­op­ment of new treat­ments while in­creas­ing our un­der­stand­ing of how these treat­ments can ben­e­fit pa­tients more broad­ly.”

Kapoor of­fered an il­lus­tra­tion in a blog post:

For ex­am­ple, through the Ax­on Reg­istry, we want to be able to re­search trends in pro­gres­sion and track the im­pact of spe­cif­ic treat­ments over time for con­di­tions such as mul­ti­ple scle­ro­sis, mi­graine and epilep­sy. We aim to im­prove treat­ments and dis­cov­er cures for the one in six peo­ple af­fect­ed by neu­ro­log­ic dis­ease.

Un­like some of its coun­ter­parts, though, Ve­r­ana doesn’t boast about its Big Phar­ma col­lab­o­ra­tions — at least not yet.

But Ve­r­ana does work with a num­ber of life sci­ences and di­ag­nos­tics play­ers, Kapoor said, of­fer­ing ser­vices in four ar­eas: pro­to­col op­ti­miza­tion, pa­tient re­cruit­ment, site en­gage­ment and re­al-world drug per­for­mance. And a fifth, pro­vid­ing reg­u­la­to­ry-grade da­ta for a prag­mat­ic con­trol arm in clin­i­cal tri­als that drug­mak­ers can take to reg­u­la­tors, is in the works — which in­cludes an FDA-part­nered project com­ing in a few months.

“If we were to fol­low the time­lines of our phar­ma cus­tomers, and reg­u­la­tor part­ners, we would be do­ing it soon­er,” he said. “In fact, we would be do­ing it soon­er than we want to. But what we have de­cid­ed is that over the course of this year, 2020, we’re get­ting our­selves ready for a world in which we can ac­tu­al­ly do that. So by the end of this year, I hope to be do­ing prag­mat­ic work.”

PYAA will re­main and grow in Knoxville, TN, it added, while the par­ent com­pa­ny scales up its San Fran­cis­co head­quar­ters and New York of­fice, hir­ing 45 to com­ple­ment the 85-strong work­force.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck R&D chief (YouTube)

Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 81,800+ biopharma pros reading Endpoints daily — and it's free.

As­traZeneca’s $7B ADC suc­ceeds where Roche failed, im­prov­ing sur­vival in gas­tric can­cer

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.