Af­ter abrupt­ly pulling its mar­ket­ing ap­pli­ca­tion, DBV may be left with peanuts in race against Aim­mune

They say slow and steady wins the race. In the sprint to mar­ket the first peanut al­ler­gy treat­ment, hare DBV Tech­nolo­gies $DB­VT has just fum­bled, an­nounc­ing on Wednes­day that it had re­scind­ed the mar­ket­ing ap­pli­ca­tion for its peanut al­ler­gy patch, fol­low­ing dis­cus­sions with FDA reg­u­la­tors who are seem­ing­ly un­hap­py with the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted. Mean­while, tor­toise Aim­mune $AIMT is now in pole po­si­tion to leapfrog its ri­val to se­cure first-mover ad­van­tage in the so-far un­der­served mar­ket.

To be sure, both com­pa­nies have had their share of ups and downs. In Oc­to­ber 2017, DBV re­port­ed its treat­ment — dubbed Vi­askin Peanut — was un­able to mark a sta­tis­ti­cal­ly sig­nif­i­cant sep­a­ra­tion from a place­bo in a Phase III tri­al, oblit­er­at­ing its shares, al­though the Parisian drug de­vel­op­er said it would march ahead with a mar­ket­ing ap­pli­ca­tion. Four months lat­er in 2018, arch ri­val Aim­mune came out with piv­otal da­ta on its drug, AR101, which were de­cid­ed­ly pos­i­tive, but in­vestors took is­sue with the mag­ni­tude of pa­tients that dropped out of the drug arm. In re­sponse, Nestlé Health Sci­ence-backed Aim­mune al­so so­lid­i­fied its plans to sub­mit its ap­pli­ca­tion, which is ex­pect­ed by the end of 2018.

Daniel Tassé

“Al­though the agency did not ref­er­ence any med­ical or clin­i­cal ques­tions with the sub­mis­sion of Vi­askin Peanut, the FDA did com­mu­ni­cate that the lev­el of de­tail with re­gards to da­ta on man­u­fac­tur­ing and qual­i­ty con­trols was in­suf­fi­cient in the BLA,” said DBV chief Daniel Tassé said in a state­ment on Wednes­day.

JMP an­a­lyst Li­isa Bayko was not as con­vinced.  “Man­age­ment as­sumes that there are no con­cerns around Vi­askin Peanut’s clin­i­cal mod­ule be­cause there were no ques­tions from the FDA re­gard­ing that sec­tion of the BLA. How­ev­er, the com­pa­ny nev­er di­rect­ly asked if the rest of the BLA was ac­cept­able for re­view,” she wrote in a note.

Un­sur­pris­ing­ly the two com­pa­nies’ shares were trad­ing in op­po­site di­rec­tions: DBV’s stock crashed near­ly 49% pre-mar­ket, while Aim­mune’s shares climbed about 6% be­fore the bell.

An­a­lysts keen­ly watch­ing the tri­als and tribu­la­tions of the pair of drug de­vel­op­ers in­di­cat­ed that Aim­mune is now well-poised to be­come the first FDA-ap­proved treat­ment. They al­so ex­pressed out­rage that DBV pro­vid­ed no clear time­line on when and how the ap­pli­ca­tion’s is­sues would be re­solved.

Derek Archi­la

“We are sur­prised this type of in­for­ma­tion would not have been dis­cussed with the agency pri­or to the BLA sub­mis­sion (com­pa­ny has fast track and break­through sta­tus al­low­ing them in­creased agency in­ter­ac­tion) to en­sure the re­quired da­ta was part of the pack­age…this event will on­ly in­crease in­vestors’ skep­ti­cism on man­age­ment’s abil­i­ty to ex­e­cute on its reg­u­la­to­ry ini­tia­tives, which were al­ready con­tro­ver­sial,” Stifel’s Derek Archi­la wrote.

“While DB­VT’s new CEO in­di­cat­ed he an­tic­i­pates be­ing able to pro­vide the ad­di­tion­al in­for­ma­tion need­ed to sup­port the re-fil­ing of the BLA, he of­fered no clear time­lines for a BLA re-sub­mis­sion nor tim­ing on when he ex­pects to up­date in­vestors. The CEO on­ly in­di­cat­ed on the call it would not be “un­rea­son­able” to ex­pect an up­date from the com­pa­ny dur­ing 1Q19, but ul­ti­mate­ly we don’t know when it will oc­cur.”

Bri­an Sko­r­ney

Baird’s Bri­an Sko­r­ney was even more skep­ti­cal of DBV’s for­tunes, sug­gest­ing the de­lay could spell fur­ther dis­as­ter:

(T)his dy­nam­ic like­ly low­ers the prob­a­bil­i­ty that FDA would be will­ing to over­look the Phase 3 fail­ure. Un­der a 1H19 re­view, an Ad­Com would like­ly be set up with the com­pa­ny and pa­tient ad­vo­cates mak­ing the case that “there is noth­ing else avail­able”. Un­der any like­ly re­sub­mis­sion time­line, AR101 is like­ly to have been ap­proved by a Vi­askin Ad­Com and the FDA may be less flex­i­ble when a stan­dard of care ex­ists.

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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