FDA stiff arms Evo­lus' ri­val to Al­ler­gan’s block­buster Botox, but ex­ecs promise a snap re­sponse

Evo­lus’ $EOLS at­tempt to field a ri­val to Al­ler­gan’s Botox has run in­to prob­lems at the FDA.

The biotech an­nounced Wednes­day morn­ing that the FDA has hand­ed the com­pa­ny a com­plete re­sponse let­ter for DWP-450 (prabot­u­linum­tox­i­nA). But the ex­ec­u­tive team quick­ly pinned the blame on man­u­fac­tur­ing is­sues, say­ing they can bat their re­vised ap­pli­ca­tion back to reg­u­la­tors in 90 days.

The biotech’s state­ment starts with an an­nounce­ment that the FDA has con­firmed “the fa­vor­able com­ple­tion of its pre-ap­proval in­spec­tion of Dae­woong’s man­u­fac­tur­ing fa­cil­i­ty in South Ko­rea which was pur­pose built for pro­duc­tion of DWP-450.” They go on to say that de­spite the re­jec­tion, they’re stay­ing up­beat — re­gard­less of what in­vestors might think.

And they weren’t near­ly as up­beat as man­age­ment. The biotech’s stock plunged 30% on the news.

David Moataze­di

CEO David Moataze­di — an Al­ler­gen vet who took the job just a lit­tle more than a week ago — says the re­jec­tion has noth­ing to do with da­ta, sta­tis­tics, safe­ty or phar­ma­col­o­gy of their prod­uct. “The re­main­ing ques­tions are man­age­able,” he told in­vestors on a call this morn­ing.

The biotech sig­naled at the be­gin­ning of the year that it had some se­ri­ous man­u­fac­tur­ing is­sues to deal with af­ter the FDA is­sued a heav­i­ly redact­ed re­port on their in­spec­tion of the fa­cil­i­ty.

But the com­pa­ny de­clined to get spe­cif­ic, even af­ter be­ing pressed by Wells Far­go an­a­lyst David Maris.

“Ob­vi­ous­ly it’s a con­fi­den­tial doc­u­ment so we’re not go­ing to give gran­u­lar­i­ty,” not­ed CMO Rui Ave­lar.

The com­pa­ny says that it will get a Type 2 re­view for the re­vised pitch, set­ting up time­line for a planned launch next spring. 

“We’ve large­ly de-risked the clin­i­cal de­vel­op­ment pro­gram,” says the CEO. “The path­way to com­mer­cial­iza­tion is now clear” af­ter the feed­back. And Moataze­di adds he’ll start scal­ing for a com­mer­cial launch­ing 2019.

He de­clined, though, to get in­to the specifics of the FDA’s ques­tions.

“We are pleased with the progress we con­tin­ue to make with the FDA, and this CRL con­firms our con­fi­dence in our clin­i­cal sub­mis­sion,” said Moataze­di in a state­ment. “De­fi­cien­cies cit­ed with­in the CRL are iso­lat­ed to CMC mat­ters and we ex­pect to re­spond com­pre­hen­sive­ly with­in 90 days. Over­all, we view these up­dates as pos­i­tive, which to­geth­er give us the line of sight nec­es­sary to build our com­mer­cial in­fra­struc­ture. We look for­ward to work­ing close­ly with the FDA and re­main com­mit­ted to bring­ing DWP-450 to mar­ket by spring 2019.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

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

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”