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.”

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Covid-19 roundup: Mer­ck­'s $356M sup­ply deal on hold as FDA asks for more da­ta; FDA ap­proves Pfiz­er/BioN­Tech vac­cine stor­age at stan­dard freez­er temps

Merck is pushing back plans to supply the US government with a Covid-19 drug after the FDA asked for more data to support an emergency use authorization.

The antibody, MK-7110, had looked promising in a Phase III study conducted by OncoImmune before Merck came along and bought the biotech for $425 million. At the interim analysis, investigators looked at data from 203 patients and concluded that a single dose of the drug cut the risk of death or respiratory failure by more than 50% among severe patients. And those taking the drug had a 60% higher chance of improvement in clinical status compared to placebo.

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CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

Fatty liver conceptual image, 3D illustration showing fatty liver silhouette made from micrograph of liver steatosis (Shutterstock)

The path to NASH: un­der­stand­ing the role of se­vere obe­si­ty in a com­plex, mul­ti-sys­tem dis­ease

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We often think a person’s transition from a healthy to a diseased state is binary. But that’s often not the case. In reality, the onset of a disease is not something that occurs overnight, and the majority lie on a continuum that is impacted by a multitude of factors. Some of these factors are in a patient’s control. Others are not.

This is the case in nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), two of the most complex diseases that “live” on this proverbial continuum. The clinical onset of NAFLD — and ultimately NASH — is a complex process that is closely related to obesity, insulin resistance and impaired adipose tissue metabolism.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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