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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine -- so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

Long jour­ney for DBV peanut patch ends in re­jec­tion by FDA

DBV Technologies’ long and winding saga with the FDA has ended — for now, at least — with a CRL for their peanut allergy skin patch.

The rejection comes 21 months after the company first filed for approval. At the time, the French biotech was in a two-way race with California’s Aimmune to produce the first FDA-approved treatment for peanut allergy. But since then Aimmune cleared that hurdle, while DBV, after a withdrawal and resubmission, indicated that communication between them and regulators had broken down.  In June, the company began cutting programs and employees.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

Endpoints Premium

Premium subscription required

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