In­cyte nabs pri­or­i­ty re­view for bile duct can­cer drug; Temasek shows in­ter­est in an­oth­er Wood­ford dar­ling — re­port

In­cyte’s de­ci­sion to stop co-fund­ing baric­i­tinib in fa­vor of oth­er pipeline op­por­tu­ni­ties is pay­ing off, as the FDA grants pri­or­i­ty re­view to pemi­ga­tinib in a type of pre­vi­ous­ly treat­ed, lo­cal­ly ad­vanced or metasta­t­ic cholan­gio­car­ci­no­ma. Pa­tients cur­rent­ly have “lim­it­ed treat­ment op­tions be­yond first-line chemother­a­py and of­ten face a poor prog­no­sis,” said Pe­ter Lang­muir, group vice pres­i­dent for tar­get­ed ther­a­peu­tics. The drug in­hibits fi­brob­last growth fac­tor re­cep­tor, or FGFR, and has been shown to in­duce an over­all re­sponse rate of 36% with a me­di­an du­ra­tion of re­sponse of 7.5 months among pa­tients with FGFR2 fu­sions or re­arrange­ments. The PDU­FA date is set for May 30, 2020.

→ Af­ter ex­tend­ing a $90 mil­lion life­line to Benev­o­len­tAI, Sin­ga­pore’s Temasek is re­port­ed­ly eye­ing an­oth­er biotech uni­corn in the port­fo­lio of the strug­gling fund for­mer­ly man­aged by Neil Wood­ford. The firm is in talks to in­vest in DNA se­quenc­ing play­er Ox­ford Nanopore, the Sun­day Times re­port­ed. The high fly­ing Ox­ford spin­out has been look­ing to raise £125m ($161 mil­lion) af­ter aban­don­ing plans to go pub­lic, ac­cord­ing to the pa­per, but it’s un­clear whether Temasek wants to par­tic­i­pate in that fi­nanc­ing or a sep­a­rate arrange­ment.

→ Four months af­ter Am­gen and Al­ler­gan launched the first Her­ceptin biosim­i­lar in the US, My­lan and Bio­con are catch­ing up with their own copy­cat, Ogivri. De­spite scor­ing an FDA ap­proval ear­li­er than ri­vals, their set­tle­ment with Roche pre­vent­ed them from rolling out the drug un­til to­day. It marks the sec­ond biosim­i­lar that My­lan is mar­ket­ing in the US through its part­ner­ship with Bio­con, fol­low­ing the ar­rival of Neu­las­ta knock­off Ful­phi­la. Ogivri is al­so ap­proved in more than 80 coun­tries world­wide, the com­pa­nies said.

→ As In­ter­cept turns the fi­nal reg­u­la­to­ry cor­ner on its ex­per­i­men­tal NASH drug, the biotech is pro­mot­ing Ja­son Cam­pagna to the CMO role. Hav­ing joined as the NASH pro­gram leader in 2016 from The Med­i­cines Com­pa­ny, Com­pagna will now over­see strate­gic med­ical and sci­en­tif­ic moves while the R&D, reg­u­la­to­ry, med­ical af­fairs and safe­ty & phar­ma­covig­i­lance units all work to­geth­er to push obeti­cholic acid as the first ap­proved ther­a­py for the big liv­er dis­ease.

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.

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.”

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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.

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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.

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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.

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Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

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.

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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.

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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.