DBV lays off em­ploy­ees, scales down pro­grams af­ter re­ceiv­ing no word from FDA

For years, it was a two-com­pa­ny race to de­vel­op the first treat­ment for peanut al­ler­gy. Then in Jan­u­ary, Aim­mune won ap­proval for its peanut pow­der pill and now it looks like their com­peti­tor and the erst­while fron­trun­ner is strug­gling to stay alive.

DBV Tech­nolo­gies said to­day that it has not heard from the FDA since the agency said they were con­cerned about how ef­fec­tive DBV’s ex­per­i­men­tal peanut patch would be and, as a re­sult, plan to lay off a “sig­nif­i­cant” num­ber of em­ploy­ees. These cuts will be part of a “glob­al and com­pre­hen­sive re­struc­tur­ing plan” that will be­gin im­me­di­ate­ly and at­tempt to keep the com­pa­ny sol­vent past Q1 2021.

A spokesper­son for DBV de­clined to com­ment on how many em­ploy­ees would be laid off and in what de­part­ments, but the com­pa­ny’s re­lease in­di­cates they will si­lo them­selves tight­ly around their lead drug, scal­ing down both their oth­er clin­i­cal pro­grams and their pre­clin­i­cal re­search. Those pro­grams in­cludes a cow’s milk al­ler­gy patch, a hen’s egg patch, a di­ag­nos­tics pro­gram with Nestlé and five oth­er non-dis­closed projects.

Daniel Tassé

“We have care­ful­ly re­viewed the sit­u­a­tion and giv­en the pre­vail­ing un­cer­tain­ties, the goal of the plan that we are launch­ing aims to pre­serve our core func­tions, ex­tend our cash run­way and main­tain op­er­at­ing lat­i­tude to bring the first and on­ly epi­cu­ta­neous im­munother­a­py for the treat­ment of peanut al­ler­gy to pa­tients in need, if ap­proved,” CEO Daniel Tassé said in a state­ment.

The trou­bles for DBV be­gan near­ly a year and a half ago, when the French com­pa­ny pulled their first FDA sub­mis­sion, cit­ing con­cerns that the BLA lacked “suf­fi­cient de­tail re­gard­ing da­ta on man­u­fac­tur­ing pro­ce­dures and qual­i­ty con­trols.” Known as Vi­askin, the com­pa­ny’s patch is de­signed to build tol­er­ance in kids with se­vere peanut al­ler­gy. Aim­mune was try­ing to do the same with a pill, but DBV had got­ten to reg­u­la­tors first, and were in a po­si­tion to be­come the first ap­proved ther­a­py be­fore they with­drew the ap­pli­ca­tion.

DBV re­filed last Au­gust and the FDA ac­cept­ed their re­view in Oc­to­ber, set­ting up an ad­vi­so­ry com­mit­tee hear­ing in May and a de­ci­sion by Au­gust 2020.  Then in March, two months af­ter Aim­mune won ap­proval, DBV dis­closed that the FDA had ques­tions about their sec­ond patch too, this time about ef­fi­ca­cy.

The com­pa­ny had just missed the pri­ma­ry end­point on their Phase III tri­al, falling short of a 15% con­fi­dence in­ter­val they had set for im­proved peanut tol­er­ance af­ter one year. Tassé said, though, that the is­sue had to do with re­ports that kids could scratch the patch off.

“This has noth­ing to do with the 15% con­fi­dence in­ter­val,” he told in­vestors on a con­fer­ence call. “The ques­tion for the agency has to do with the po­ten­tial im­pact on ef­fi­ca­cy of path ad­he­sion and patch at­tach­ments.”

DBV sub­mit­ted da­ta it said showed the stick­i­ness of the patch didn’t in­ter­fere with ef­fi­ca­cy. Nev­er­the­less, the FDA can­celed the ad­vi­so­ry com­mit­tee hear­ing, rais­ing con­cern among some an­a­lysts that a de­ci­sion on the drug would like­ly be de­layed and it could be re­ject­ed.

“At this point, we view DB­VT as ef­fec­tive­ly dead in the wa­ter,” Baird an­a­lyst Bri­an Sko­r­ney, who has been con­sis­tent­ly bull­ish on Aim­mune’s prospects, said in a note.

Joseph Schwartz of SVB Leerink, though far less bear­ish, still called it “a sticky sit­u­a­tion.”

“With many cur­rent un­knowns,” he wrote, “we look for­ward to up­dates on DB­VT’s dis­cus­sions with the FDA and the next steps for Vi­askin Peanut’s BLA re­view.”

Now DBV said that al­though it asked for guid­ance, dis­cus­sions nev­er ma­te­ri­al­ized, aside from a mes­sage that the da­ta were be­ing re­viewed and the tar­get date for a de­ci­sion was still Au­gust 5. The com­pa­ny’s cash bal­ance now stands at €262.4 mil­lion. With the cuts, that will be enough to go “be­yond” first quar­ter of 2021, they said.

So­cial: Daniel Tassé (DBV Tech­nolo­gies)

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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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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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.

Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.