Analy­sis: Pfiz­er tal­lies an im­pres­sive ar­ray of late-stage cat­a­lysts for can­cer, gene ther­a­pies and more

Pfiz­er ex­ecs ran through their 2018 late-stage pipeline plan on Tues­day, high­light­ing the key cat­a­lysts that await dur­ing their Q4 call with an­a­lysts. And can­cer drugs fig­ured promi­nent­ly in the dis­cus­sion.

We won’t have long to wait be­fore the news gets start­ed.

Mikael Dol­sten

First up, the Phase III PROS­PER da­ta for Xtan­di, which is po­si­tion­ing it­self against J&J’s next-gen drug for Zyti­ga. Pfiz­er and its part­ners at Astel­las are anx­ious to get the FDA re­view un­der­way for non­metasta­t­ic prostate can­cer, which could add con­sid­er­ably to its fran­chise val­ue as gener­ics start to slice and dice the mar­ket for J&J’s ri­val ther­a­py Zyti­ga. J&J has a next-gen drug in late-stage de­vel­op­ment for non­metasta­t­ic prostate can­cer which is cru­cial to its near-term abil­i­ty to com­pete with Pfiz­er.

Then there’s ta­la­zoparib, the PARP in­hibitor that Pfiz­er ac­quired in the big $14 bil­lion Medi­va­tion buy­out, with pos­i­tive late-stage da­ta on BR­CA-pos­i­tive metasta­t­ic breast can­cer.

Their PD-L1 in­hibitor Baven­cio, al­lied with Mer­ck KGaA, stum­bled bad­ly on third-line gas­tric can­cer re­cent­ly. But re­searchers are fol­low­ing up on sec­ond-line non-small cell lung can­cer and first-line re­nal cell car­ci­no­ma in com­bi­na­tion with In­ly­ta. A triple com­bo us­ing Baven­cio, Pfiz­er’s 4-1BB agent, and their OX40 mon­o­clon­al an­ti­body in sol­id tu­mors is be­ing stud­ied.

R&D chief Mikael Dol­sten sum­ma­rized the top on­col­o­gy tri­als this way:

We have now five piv­otal stud­ies over the next 18 to 24 months with var­i­ous Baven­cio com­bi­na­tions that we think will be re­al­ly in­ter­est­ing to watch. Ovar­i­an sec­ond-line and third-line with chemo, re­nal first-line…, gas­tric first-line on main­te­nance of Baven­cio af­ter chemo, blad­der first-line…Baven­cio com­bined with var­i­ous chemo com­bi­na­tions….”

And fi­nal­ly, I want to say that we are re­al­ly one of the few that have both an IO agent Baven­cio and a PARP in­hibitor ta­la­zoparib and we do think that will be a very pow­er­ful com­bi­na­tion and we’re run­ning broad bas­ket stud­ies over many sol­id tu­mors and ex­pect op­por­tu­ni­ties to take from those dataset in­to piv­otal stud­ies in the near term.

Ian Read

Pfiz­er CEO Ian Read had this to add:

I would like to point out that while we are be­hind in lung now our ex­pec­ta­tions are we have two im­por­tant read­outs; one this year and one lat­er on which is in – we have very cre­ative de­sign and let’s see what re­sults are in lung and how pos­i­tive it can be. We haven’t any­way giv­en up and our at­tempt to par­tic­i­pate in that large mar­ket.

Then Read ticked off three more top prospects in on­col­o­gy: Lor­la­tinib for ALK-pos­i­tive cas­es, the two-time los­er da­comi­tinib — a TKI — that came through in EGFR mu­tat­ed non-small cell lung can­cer and glas­deg­ib, an oral SMO in­hibitor ini­tial­ly cod­ed PF-04449913, for acute myeloid leukemia, based on Phase II re­sults.

There’s a ma­jor Phase III pro­gram un­der­way for their JAK1 in atopic der­mati­tis, a Phase III C diff vac­cine and a big ef­fort un­der­way in gene ther­a­pies for he­mo­phil­ia A and B — which in­spired the phar­ma gi­ant to spend $100 mil­lion on build­ing a gene ther­a­py man­u­fac­tur­ing cen­ter­ing Sand­ford, NC.

Dol­sten took on the piv­otal pro­gram for the NGF pain drug tanezum­ab, part­nered with Lil­ly. He said:

We are very ex­cit­ed about the tri­al of six dif­fer­ent stud­ies, 7000 pa­tients that are start­ing to read out ear­ly fall this year and then each of the tri­als fur­ther on in­to 2019. We have a unique po­si­tion in the space as we gath­ered tremen­dous ex­pe­ri­ence and in­sight in how to man­age our NGF an­ti­body and deal with rare events….

An­a­lysts have been rigid­ly fo­cused on M&A at Pfiz­er, which put the BD team on pause as they wait­ed for tax re­form to come through. Now that that smoke has be­gun to clear, cut­ting Pfiz­er’s prospec­tive tax rate by 6 points, to 17%, we’re like­ly to see the phar­ma gi­ant get back in­to the M&A game as well. Now that Pfiz­er has lopped off neu­ro­sciences, it should have plen­ty of abil­i­ty to add fresh pro­grams to the pipeline. And Read’s track record sug­gests he’d like to stay fo­cused on late-stage de­vel­op­ment.

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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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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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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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.

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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.

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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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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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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.