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.

Janet Woodcock (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

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Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

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