Pfiz­er's JAK in­hibitor clears sec­ond piv­otal eczema study, but can it top­ple Re­gen­eron's Dupix­ent?

The atopic der­mati­tis mar­ket is crowd­ed. Dupix­ent, from Re­gen­eron and Sanofi, may be king of the ar­se­nal of ther­a­pies to com­bat eczema — but var­i­ous drug­mak­ers big and small are out to usurp its throne. Pfiz­er on Fri­day made its pitch, with a sec­ond slate of pos­i­tive late-stage da­ta on its ex­per­i­men­tal drug, abroc­i­tinib.

Abroc­i­tinib be­longs to a class of drugs called Janus ki­nase (JAK) in­hibitors — which have been plagued with safe­ty con­cerns. Named af­ter the two-faced Ro­man God Janus, the fam­i­ly con­sists of four en­zymes: JAK1, JAK2, JAK3 and TYK2, which are as­so­ci­at­ed with cy­tokine re­cep­tors on the sur­face of cells and form part of a path­way in­volved in in­flam­ma­to­ry and im­mune re­spons­es.

Abroc­i­tinib, a JAK1 in­hibitor, is thought to mod­u­late mul­ti­ple cy­tokines in­volved in the patho­phys­i­ol­o­gy of eczema in­clud­ing in­ter­leukin (IL)-4, IL-13, IL-31, and in­ter­fer­on gam­ma. On Fri­day, the US drug­mak­er said it had met goals of the 391-pa­tient JADE MONO-2 study, which test­ed two dos­es (100mg and 200mg once dai­ly) of the drug against a place­bo.

Con­sis­tent with the JADE MONO-1 tri­al, da­ta from this study showed that by week 12 the per­cent­age of pa­tients achiev­ing each co-pri­ma­ry ef­fi­ca­cy end­point, as well as each key sec­ondary end­point, with ei­ther dose of abroc­i­tinib was sta­tis­ti­cal­ly sig­nif­i­cant­ly high­er than place­bo. In ad­di­tion, a sta­tis­ti­cal­ly sig­nif­i­cant num­ber of pa­tients achieved a re­duc­tion in pru­ri­tus (se­vere itch­ing) by week 2, as mea­sured by a four-point or larg­er re­duc­tion in itch sever­i­ty mea­sured with the pru­ri­tus nu­mer­i­cal rat­ing scale (NRS).

De­tailed da­ta from JADE MONO-1 are ex­pect­ed at a Madrid con­fer­ence in Oc­to­ber, Pfiz­er $PFE said, adding that re­sults from a tri­al test­ing abroc­i­tinib against an ac­tive con­trol should read­out in spring 2020.

There are var­i­ous JAK in­hibitors on the mar­ket ap­proved for a range of im­mune-me­di­at­ed dis­eases. Pfiz­er al­ready has a JAK1/JAK3 in­hibitor — Xel­janz — in its port­fo­lio, al­though its use has been blight­ed by reg­u­la­to­ry re­stric­tions af­ter the high­er dose of the block­buster drug was found to be as­so­ci­at­ed with the risk of blood clots and death.

Eli Lil­ly’s $LLY JAK1/JAK2 Olu­mi­ant, mean­while, was ini­tial­ly re­ject­ed by the US agency due to safe­ty con­cerns — on­ly to even­tu­al­ly se­cure ap­proval for the low­er dose. Lil­ly’s part­ner, In­cyte $IN­CY, elect­ed to walk away from co-fund­ing the drug’s de­vel­op­ment as fears about the ben­e­fit-risk pro­file of the class of drugs ac­cu­mu­lat­ed. Last month Ab­b­Vie’s $AB­BV JAK1 upadac­i­tinib was cleared by the FDA for rheuma­toid arthri­tis with a black box warn­ing, a fea­ture an­a­lysts ex­pect will be in­cor­po­rat­ed in­to the la­bel of Gilead’s $GILD Gala­pa­gos-part­nered fil­go­tinib, should it se­cure ap­proval.

In terms of atopic der­mati­tis specif­i­cal­ly, Re­gen­eron $REGN and Sanofi’s $SNY Dupix­ent (chem­i­cal­ly known as dupilum­ab) was the first bi­o­log­ic to win ap­proval for the con­di­tion in 2017, and is now the de-fac­to leader in the mar­ket. It is en­gi­neered to in­hib­it the sig­nal­ing of IL-4 and IL-13 — two pro­teins that like­ly play a key role in the in­flam­ma­tion that un­der­lies eczema and a host of al­ler­gic dis­eases.

“While dupilum­ab (dupi) has set an ex­treme­ly high bar in AD, the evolv­ing com­pet­i­tive land­scape has not been quite as strong yet. Re­cent de­vel­op­ments serve as im­por­tant re­minders that the ‘crowd­ed’ AD land­scape may not look quite as con­gest­ed once the dust starts to set­tle and the win­ners cre­ate sep­a­ra­tion from the rest of the pack,” SVB Leerink an­a­lysts wrote in a note in June.

In Pfiz­er’s JADE MONO-2 study, abroc­i­tinib’s safe­ty pro­file was less than straight­for­ward. The fre­quen­cy of treat­ment-emer­gent ad­verse events was high­er in treat­ment arms ver­sus place­bo, and one pa­tient with co-ex­ist­ing car­dio­vas­cu­lar risk fac­tors died three weeks fol­low­ing the study from un­known eti­ol­o­gy — al­though the drug­mak­er said the event was not re­lat­ed to abroc­i­tinib.

“While we ex­pect ef­fi­ca­cy for abroc­i­tinib to be po­ten­tial­ly com­pa­ra­ble to Re­gen­eron’s Dupix­ent, many ques­tions re­main whether abroc­i­tinib is safe enough to be a for­mi­da­ble com­peti­tor to Dupix­ent,” Cred­it Su­isse’s Evan Seiger­man wrote in a note. “We ex­pect in­ten­si­fy­ing com­pe­ti­tion in AD over the next few years from nov­el JAK in­hibitors (abroc­i­tinib, Ab­b­Vie’s upadac­i­tinib) and nov­el bi­o­log­ics (name­ly tar­get­ing IL-13 and 33).”

So­cial im­age: AP

Nick Galakatos, Blackstone global head of life sciences

Nick Galakatos and the Black­stone team now have a record $4.6B to in­vest in bio­phar­ma, with a big fo­cus on push­ing com­pa­nies over the top

Nick Galakatos and his team at Blackstone Life Sciences have seen their biggest opportunities swell up in mostly established players who don’t have all the money they need to accomplish everything on the to-do list. And right now, with the industry booming, that’s a long list with some hefty needs.

The Blackstone team has neatly tied up the largest private fund ever raised in life sciences for making big dreams come true in biopharma. Late Thursday, Blackstone put out word that they had closed their highly anticipated fund with the projected $4.6 billion all in.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surging again off data that suggest its antiviral remdesivir might improve survival.

The new data come from an analysis Gilead conducted comparing the death rate and recovery time of patients in one of its remdesivir trials to a group of 800 patients “with similar baseline characteristics and disease severity” who received only standard-of-care around the same time. The result, they said, suggested that patients who received remdesivir had a 62% better chance at surviving than those who did not.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Top biotech an­a­lyst projects a gloomy out­look for Pfiz­er's JAK port­fo­lio

Many in the pharma world are hoping — better yet, expecting — JAK inhibitors to provide one of the next big boons for the industry. Few have invested as heavily in this area as Pfizer, which boasts a portfolio including Xeljanz and at least five mid-to-late stage candidates in the pipeline.

But a top Wall Street analyst is pumping the brakes on just how much good fortune is in store for the Big Pharma.

Hal Barron, GSK

Win or lose on the mar­ket­ing OK, the FDA just gunned down GSK’s bright hopes for their BC­MA ther­a­py

The FDA’s ODAC — the Oncologic Drugs Advisory Committee — has a well-known bias in favor of adding new cancer drugs to the market, even if efficacy is at best marginal and serious safety issues demand careful management.

Doctors want as many arrows in their quiver as they can get. And when patients are dying after failing multiple drugs, why not give it a go one more time?

GlaxoSmithKline, though, is about to test out how their new BCMA antibody drug conjugate belantamab mafodotin can do after being mauled in an in-house FDA review, ahead of the Tuesday expert panel discussion. Even if the agency goes ahead with an expected green light, this drug will likely be constrained to a small niche — icing any plans they may have for making waves in oncology anytime soon.

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Covid-19 roundup: BioN­Tech go­ing head-to-head with Mod­er­na as PhI­II mR­NA launch looms; Tri­al on Shin­zo Abe’s once-fa­vorite an­tivi­ral is in­con­clu­sive

It’s a race to the Phase III finish line now for the 2 leading mRNA vaccines in the pipeline for Covid-19.

BioNTech chief Ugur Sahin told the Wall Street Journal that his company will start Phase III testing of their vaccine later this month, setting them up to lateral the data to regulators before the end of this year.

That puts them essentially on the exact same schedule as Moderna is dedicated to. The Massachusetts rival to BioNTech also expects to launch Phase III this month. Lots of rumors have circulated about delays and conflict among the scientists advancing the Moderna jab, but the biotech has consistently stuck to its plan to start a late-stage pivotal this month.

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Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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