Pre­emp­tive sham­ing as­sault on No­var­tis’ CAR-T pi­o­neer un­der­scores a dis­con­nect on R&D costs

It’s no se­cret that tax­pay­ers fund a lot of the ba­sic sci­ence work done in the US. But should that ear­ly re­search sup­port for new drugs trans­late in­to low­er prices?

A group called Pa­tients for Af­ford­able Drugs thinks so, launch­ing a pre­emp­tive strike against No­var­tis’ CAR-T drug CTL019— now up for an ap­proval — de­mand­ing fair pric­ing in light of the $200 mil­lion-plus that was used to back the trans­la­tion­al work on CAR-T in gen­er­al. There’s no break­down on what slice of that helped No­var­tis.

David Mitchell, Pa­tients for Af­ford­able Drugs

“I urge you in the strongest pos­si­ble terms to price your CAR-T drug fair­ly in light of the fact that U.S. tax­pay­ers in­vest­ed hun­dreds of mil­lions of dol­lars to de­vel­op CAR-T be­fore your com­pa­ny be­came se­ri­ous­ly in­volved,” David Mitchell, pres­i­dent of Pa­tients For Af­ford­able Drugs, wrote in the let­ter to No­var­tis chief Joe Jimenez.

That com­ment de­serves some added con­text.

No­var­tis spent close to $9 bil­lion on R&D last year, about 18% of rev­enue. The phar­ma gi­ant spent more than $9 bil­lion on R&D the year be­fore that, and it will do the same in 2017. While it will like­ly pub­licly han­dle this gam­bit on pric­ing with its usu­al wood­en (and very cor­po­rate) lack of feel­ing, it has no rea­son to apol­o­gize for what it charges for its CAR-T.

At one point the com­pa­ny had a large, 400-em­ploy­ee group de­vot­ed to cell and gene ther­a­py and a blank-check ap­proach to CAR-T from Jimenez that in­clud­ed huge sup­port for the Uni­ver­si­ty of Penn­syl­va­nia. That strat­e­gy was scrapped, but No­var­tis paid dear­ly to stay a pi­o­neer in this per­son­al­ized med­i­cine field, as Kite and Juno took their own in­de­pen­dent ap­proach in dri­ving de­vel­op­ment.

No­var­tis CEO Joe Jimenez

The first CAR-Ts won’t be cheap by any stan­dard. Rev­o­lu­tions in drug sci­ence don’t come cheap. But while No­var­tis and Kite and Juno and the oth­ers owe a debt to fed­er­al­ly spon­sored R&D in the field, the ini­tial amounts pro­vid­ed by the feds are on­ly a small part of the to­tal.

The pub­lic doesn’t gen­er­al­ly rec­og­nize that. But they should if we want to dis­cuss drug pric­ing se­ri­ous­ly. There are plen­ty of big is­sues sur­round­ing pric­ing and rein­ing in costs that de­serve re­al de­bate. But this is the wrong ap­proach on R&D.

The NIH is be­com­ing more di­rect­ly in­volved in drug de­vel­op­ment than ever be­fore. That’s ev­i­dent in two oth­er sto­ries in to­day’s edi­tion, from Thomas Wynn’s de­ci­sion to move from NIH to Pfiz­er and the new work on TCR en­gi­neer­ing re­lat­ed to Kite. That move needs to be fos­tered, if we’re se­ri­ous about get­ting new drugs to pa­tients.

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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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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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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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: 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.

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