Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has re­ject­ed Ver­ri­ca’s new drug ap­pli­ca­tion for VP-102 again, with the com­pa­ny pin­ning the CRL on prob­lems at a CMO that it was part­nered with, the com­pa­ny an­nounced Mon­day.

The FDA didn’t raise is­sues that di­rect­ly re­late to the man­u­fac­tur­ing of VP-102, the com­pa­ny said, but raised “gen­er­al qual­i­ty is­sues” at the CMO’s fa­cil­i­ty. There were al­so no clin­i­cal con­cerns, it said, or need to col­lect more da­ta.

“At no time pri­or to the CRL was the Com­pa­ny no­ti­fied by the FDA of any de­fi­cien­cies at the CMO re­lat­ed specif­i­cal­ly to the man­u­fac­tur­ing of VP-102 or that their gen­er­al in­ves­ti­ga­tion of the fa­cil­i­ty would have any im­pact on the Com­pa­ny’s NDA,” the press re­lease said. “More im­por­tant­ly, the FDA did not iden­ti­fy any clin­i­cal, safe­ty or prod­uct spe­cif­ic Chem­istry, Man­u­fac­tur­ing, and Con­trols (CMC) de­fi­cien­cies re­lat­ed to VP-102.”

Ver­ri­ca says that it has got­ten word from the CMO that cor­rec­tive ac­tion is un­der­way at the site, and it’s ex­pect­ing a so­lu­tion with­in the next 30 days. CEO Ted White said in a press re­lease that he and his staff re­main con­fi­dent that there is a path for­ward for VP-102. The com­pa­ny said it will col­lab­o­rate with the CMO to en­sure that the ef­fi­ca­cy, safe­ty and qual­i­ty of the drug aren’t im­pact­ed.

As of now, it is un­clear which CMO has been chid­ed by the FDA, as Ver­ri­ca didn’t re­spond by pub­li­ca­tion time to a re­quest for com­ment.

VP-102 is a treat­ment for mol­lus­cum con­ta­gio­sum, a virus that caus­es raised bumps or le­sions on the up­per lay­ers of a per­son’s skin. The dis­ease af­fects 6 mil­lion peo­ple in the US, most­ly chil­dren, and can last longer than a year with­out treat­ment. It was al­so be­ing test­ed for the use on com­mon warts, which re­cent­ly com­plet­ed a Phase II study, and gen­i­tal warts, which al­so just com­plet­ed Phase II.

The biotech an­nounced in May that the FDA had de­layed its PDU­FA date from June 23 to Sept. 23, as reg­u­la­tors need­ed more time to re­view the train­ing pro­gram and dis­tri­b­u­tion mod­el.

That was a part of its sec­ond go-around at the agency, af­ter VP-102 was re­ject­ed in Ju­ly 2020 af­ter the FDA said that it want­ed more in­for­ma­tion on chem­istry, man­u­fac­tur­ing and con­trols, along with hu­man fac­tors. A safe­ty is­sue could arise, the FDA said, if health­care work­ers didn’t care­ful­ly fol­low in­struc­tions.

In 2018, the com­pa­ny land­ed a $75 mil­lion IPO, on the claim that they could de­vel­op the first FDA-ap­proved drug for mol­lus­cum con­ta­gio­sum. The com­pa­ny is al­so de­vel­op­ing VP-103 for the treat­ment of plan­tar warts, and LTX-315 for the treat­ment of der­ma­to­log­ic on­col­o­gy con­di­tions.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

In­cyte yanks EU ap­pli­ca­tion for PD-1 drug, cit­ing in­abil­i­ty to an­swer reg­u­la­tors' 'ma­jor con­cern­s'

Hoping to wedge its way into a crowded PD-(L)1 field, Incyte faced a huge setback when the FDA sent back its application for an initial indication earlier this year. Now, the drugmaker is giving up hope in Europe as well.

Incyte has withdrawn its EU application for PD-1 drug Zynyz, or retifanlimab, after saying it couldn’t adequately address the CHMP’s questions over survival data underpinning its market hopes in squamous cell carcinoma of the anal cavity, the EMA revealed.

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