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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Le­vo Ther­a­peu­tics miss­es pri­ma­ry end­point in PhI­II tri­al of Prad­er-Willi drug — the lat­est set­back in a dis­as­ter-prone field

Marking yet another setback in the Prader-Willi Syndrome field, Levo Therapeutics failed to hit its primary endpoint in a Phase III study of intranasal carbetocin. But the biotech is now shifting its focus to the secondary endpoints in an effort to pluck victory out of the jaws of defeat.

The disorder, characterized by a false sense of starvation, is caused by the absence or deletion of a father’s chromosome 15. Illinois-based Levo’s potential therapy involves a selective oxytocin-receptor agonist.