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.”

UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)

ARCH chief Bob Nelsen has $1.5B to prove 2 sim­ple points: ‘We’re in the most in­no­v­a­tive time ever’ and in­vestors are stay­ing

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

Lil­ly Asia Ven­tures co-leads $100M+ round for Chi­nese biotech and its late-stage lu­pus drug

Can a Chinese biotech deliver the first new lupus drug in decades? A high-profile group of VCs are betting on it.

Lilly Asia Ventures and Lake Bleu Capital are the co-headliners for RemeGen’s latest raise, which brought in more than $100 million. Hudson Bay Capital and Vivo Capital — which, like LAV, also invested in a pre-IPO round for Legend Biotech unveiled today — chimed in, as did Janchor Partners and OrbiMed.

GSK's asth­ma bi­o­log­ic Nu­cala is one step clos­er to ap­proval in key chron­ic rhi­nos­i­nusi­tis pop­u­la­tion

Months after GSK’s Nucala cleared in a pivotal rare blood disorder study, the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps.

The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps.