DBV es­ti­mates peanut al­ler­gy drug sub­mis­sion in Q3, but it may be too lit­tle too late in race with Aim­mune

DBV Tech­nolo­gies has all but so­lid­i­fied its run­ner up sta­tus in the race to bring a peanut al­ler­gy treat­ment on to the Unit­ed States mar­ket. The French drug de­vel­op­er on Wednes­day said it would re­sub­mit an ap­pli­ca­tion to mar­ket its prod­uct — Vi­askin Peanut — in the third quar­ter, af­ter with­draw­ing its ap­pli­ca­tion late last year in re­sponse to FDA con­cerns about the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted. Mean­while, arch ri­val Aim­mune’s treat­ment AR101 is cur­rent­ly un­der FDA re­view.

DBV $DB­VT re­scind­ed an ap­pli­ca­tion to mar­ket its peanut al­ler­gy patch on De­cem­ber 20, and the fol­low­ing day, Aim­mune $AIMT sub­mit­ted its ap­pli­ca­tion for peanut al­ler­gy im­munother­a­py AR101, in ef­fect leapfrog­ging its com­pe­ti­tion for a first-mover shot at cap­tur­ing the so far un­tapped mar­ket, which is ex­pect­ed to grow to $4.5 bil­lion in 2027 glob­al­ly, ac­cord­ing to Glob­al­Da­ta. The US shut­down be­gan on De­cem­ber 22 af­ter Pres­i­dent Trump in­sist­ed on $5.7 bil­lion from Con­gress to build a wall on the south­west US bor­der.

Bri­an Sko­r­ney

By mid-Jan­u­ary, Aim­mune said the health reg­u­la­tor had no­ti­fied them that it would not be able to re­view the ap­pli­ca­tion un­til the lapse in ap­pro­pri­a­tions end­ed. Ten days lat­er, on Jan­u­ary 25th, the gov­ern­ment re­opened, and the AR101 ap­pli­ca­tion was back in con­tention.

Baird’s Bri­an Sko­r­ney said DBV’s up­date made no dif­fer­ence to his ex­pec­ta­tions.

We con­tin­ue to ex­pect that, should Vi­askin Peanut reach an Ad­Com, the an­tic­i­pat­ed pri­or ap­proval of AR101 will elim­i­nate the “there is noth­ing else avail­able” ar­gu­ment for DBV Tech­nolo­gies and pa­tient ad­vo­cates, mak­ing it more dif­fi­cult for these par­ties to make a strong case for ap­proval of Vi­askin Peanut, giv­en the med­ica­tion’s weak ef­fi­ca­cy pro­file. We be­lieve that this dy­nam­ic may ul­ti­mate­ly pre­vent Vi­askin Peanut from gain­ing reg­u­la­to­ry ap­proval, clear­ing the field for Aim­mune’s AR101.

Mean­while, when Aim­mune an­nounced that the gov­ern­ment shut­down had stymied its ap­pli­ca­tion, FDA com­mis­sion­er Scott Got­tlieb threw an­oth­er span­ner in the works, sug­gest­ing in a se­ries of tweets that al­ler­genic prod­ucts are not cov­ered by user-fees, and con­se­quent­ly do not qual­i­fy for the PDU­FA process.

For Aim­mune’s im­munother­a­py, there is no clar­i­ty on its PDU­FA sta­tus, al­though the com­pa­ny is work­ing with the agency to fig­ure what the time­line for its re­view is, Sko­r­ney not­ed.

DBV’s Vi­askin Peanut — which is de­rived from freeze-dried de­fat­ted peanut flour ex­tract­ed from raw peanuts — is an al­ler­genic ex­tract and has se­cured the FDA’s break­through ther­a­py des­ig­na­tion (BTD) sta­tus. Jef­feries an­a­lyst Eun Yang sug­gest­ed that the treat­ment’s BTD sta­tus would prompt the FDA to com­plete its re­view un­der the pri­or­i­ty re­view time­line, cit­ing a reg­u­la­to­ry ex­pert. Vi­askin Peanut is clas­si­fied as a com­bi­na­tion prod­uct, thus, it will be re­viewed by the CBER (Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search) with con­sul­ta­tion from the CDRH (Cen­ter for De­vices and Ra­di­o­log­i­cal Health), al­though CDRH tends to be slow, Yang said, re­fer­ring to the ex­pert’s com­ments.

Leerink fore­cast a US mar­ket en­try in 2021 for Vi­askin Peanut “giv­en the lack of (reg­u­la­to­ry) vis­i­bil­i­ty.”

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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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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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.

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.

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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