FDA re­jects Ver­ri­ca’s skin warts pitch, a month af­ter flag­ging ap­pli­ca­tion ‘de­fi­cien­cies’

Two years ago, Ver­ri­ca Phar­ma land­ed a $75 mil­lion IPO on the promise they could de­vel­op the first ever-FDA ap­proved drug for mol­lus­cum con­ta­gio­sum, an in­fec­tion that caus­es warts. Now that won’t hap­pen, at least not this sum­mer.

The FDA to­day re­ject­ed Ver­ri­ca’s ap­pli­ca­tion to have their lead top­i­cal drug VP-102 ap­proved for mol­lus­cum con­ta­gio­sum. The news like­ly came as lit­tle sur­prise to Ver­ri­ca or its in­vestors; the biotech dis­closed in late June that the FDA sent a let­ter say­ing “de­fi­cien­cies” in their ap­pli­ca­tion pre­clud­ed a dis­cus­sion around la­bel­ing or post-mar­ket­ing com­mit­ments.

Ver­ri­ca said the FDA want­ed more in­for­ma­tion on CMC — chem­istry, man­u­fac­tur­ing and con­trols — along with hu­man fac­tors, i.e. how a user will ac­tu­al­ly han­dle the prod­uct in the re­al world. In the June let­ter, Ver­ri­ca said the FDA had raised con­cerns about a change the com­pa­ny had made af­ter it be­came clear that a cer­tain safe­ty is­sue could arise if health­care work­ers did not cor­rect­ly fol­low the in­struc­tions for ap­ply­ing their ther­a­py. Ver­ri­ca added a fea­ture to ad­dress that is­sue, but that fea­ture af­fect­ed hu­man fac­tors test­ing and re­quired “ad­di­tion­al sta­bil­i­ty da­ta.”

The com­pa­ny said “the FDA did not iden­ti­fy any clin­i­cal de­fi­cien­cies.” They are sched­ul­ing a meet­ing with the agency short­ly to dis­cuss next steps.

Ted White

“We are con­fi­dent that we can work close­ly with the FDA to ful­ly ad­dress the is­sues raised in the let­ter and we con­tin­ue to be­lieve VP-102 re­mains vi­able for FDA ap­proval,” CEO Ted White said.

De­spite the re­jec­tion, Ver­ri­ca’s stock stayed buoy­ant, dip­ping just 3% on the news. That’s per­haps be­cause the com­pa­ny is aim­ing for oth­er in­di­ca­tions and be­cause the da­ta from piv­otal tri­als for VP-102 bol­ster the odds of even­tu­al ap­proval.

In one Phase III study re­leased last sum­mer, 46% of pa­tients who re­ceived VP-102 saw their warts clear com­plete­ly, com­pared to 18% for place­bo. In a sec­ond Phase III tri­al, 54% saw com­plete clear­ance, com­pared to 13% for place­bo. Over­all, pa­tients who re­ceived the drug saw a 69% and 83% re­duc­tion in le­sions, re­spec­tive­ly.

Ver­ri­ca is al­so now test­ing VP-102 in com­mon warts. Most re­cent­ly, they an­nounced that, in an open-la­bel Phase II study, 51% of pa­tients who re­ceived the high dose of the drug saw com­plete clear­ance of their le­sions by day 84. They will use that dose in a Phase III tri­al. A Phase II tri­al in gen­i­tal warts is al­so on­go­ing, and a Phase II for plan­tar warts will start soon.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

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The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

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The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

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