Todd Zavodnick, Dermavant CEO

With top­i­cal ap­proval, Der­ma­vant looks to bring new stan­dard-of-care to plaque pso­ri­a­sis pa­tients

Der­ma­vant CEO Todd Za­vod­nick has been plot­ting to up­end the plaque pso­ri­a­sis mar­ket for years now. And with the com­pa­ny’s first ap­proval on Tues­day, he’s pulling the trig­ger.

The FDA on Tues­day ap­proved Der­ma­vant’s “cos­met­i­cal­ly el­e­gant” van­ish­ing cream tap­inarof, the first steroid-free top­i­cal med­ica­tion in its class, now mar­ket­ed as Vta­ma. And un­like oth­er launch­es, which could take months, Za­vod­nick is ready to roll it out as ear­ly as next week.

“Ap­proval doesn’t mean launch. But it does when you have a team that’s this ready and that’s put as much time as we have in­to this prepa­ra­tion, and our fo­cus in mak­ing sure that we are day one ready to have ap­proval equal launch,” he said.

Vta­ma’s web­site was live on Tues­day morn­ing, ad­ver­tis­ing that pa­tients with com­mer­cial in­sur­ance may be able to get the once-dai­ly cream with no out-of-pock­et cost, while those who are unin­sured may pay as low as $75.

Za­vod­nick has a dis­tinct com­mer­cial plan in mind for Vta­ma, as the high­ly com­pet­i­tive plaque pso­ri­a­sis mar­ket is al­ready ruled by block­buster drugs such as Ste­lara, Skyrizi and Cosen­tyx. He sees Vta­ma as a re­place­ment for steroids in the top­i­cal space while leav­ing the most se­vere cas­es to the ul­tra-ef­fec­tive bi­o­log­ics, where he says the cream could act as an add-on ther­a­py.

The cream can be used “any­where on the body for any length of time,” with no safe­ty warn­ings on the la­bel. That’s the an­tithe­sis of most steroidals, which can’t be used for more than two to four weeks and can’t be used on sen­si­tive ar­eas, Za­vod­nick said.

He com­pared the dif­fer­ence to cas­sette tapes ver­sus dig­i­tal mu­sic, adding that Vta­ma could “leapfrog der­ma­tol­ogy to the next step on the hori­zon.”

“I think it’s go­ing to be used first-line where physi­cians will move away from steroids to Vta­ma. And then I think for pa­tients that have larg­er body sur­face area, where they may be on a sys­temic, again, we know two-thirds of those pa­tients are get­ting top­i­cals, and Vta­ma would be the per­fect part­ner,” he said.

Tap­inarof, an aryl hy­dro­car­bon re­cep­tor ag­o­nist, was plucked from GSK by Vivek Ra­maswamy’s team back in 2018 for $330 mil­lion — $200 mil­lion up­front. In two Phase III tri­als, dubbed PSOAR­ING 1 and 2, the drug demon­strat­ed sig­nif­i­cant im­prove­ments in Physi­cian Glob­al As­sess­ment score, with pa­tients see­ing a min­i­mum 2-grade im­prove­ment com­pared to place­bo at week 12.

Last April, Za­vod­nick re­vealed at the Amer­i­can Acad­e­my of Der­ma­tol­ogy vir­tu­al meet­ing that around 20% of mod­er­ate to se­vere plaque pso­ri­a­sis pa­tients giv­en tap­inarof in two Phase III tri­als achieved 90% dis­ease clear­ance, mea­sured by the Pso­ri­a­sis Area and Sever­i­ty In­dex (PASI 90) at Week 12. And around 67% and 60% of pa­tients in the tri­als felt itch re­lief start­ing as ear­ly as Week 2.

“We don’t talk PASI 90s with top­i­cals,” he told End­points News at the time. “We talk PASI 90s with an oral or an in­jectable.”

In a long-term ex­ten­sion study, over 40% of pa­tients achieved com­plete dis­ease clear­ance (PGA=0) at least once.

The most com­mon ad­verse re­ac­tions, ac­cord­ing to the la­bel, were fol­li­culi­tis, na­sopharyn­gi­tis, con­tact der­mati­tis, headache, pru­ri­tus, and the flu.

Look­ing ahead, a ful­ly built team of about 150 peo­ple will soon launch a cam­paign that “will blan­ket the Unit­ed States in a way that will en­sure every der­ma­tol­o­gist and suf­fer­ing pso­ri­at­ic pa­tient is com­plete­ly aware of Vta­ma im­me­di­ate­ly,” Za­vod­nick said, while keep­ing qui­et on the de­tails.

“When pa­tients are clear and they stop … it’s a big deal be­cause they’re re­main­ing clear for a me­di­an of up to four months, and so for us, that’s re­mark­able to share,” Za­vod­nick said.

But he isn’t stop­ping there. Last year, Der­ma­vant launched a Phase III pro­gram for tap­inarof in atopic der­mati­tis, which will read out the first re­sults in the first half of next year.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Ankit Mahadevia, Spero CEO

Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.

The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.