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.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.