UP­DAT­ED: In­cyte nabs ap­proval of top­i­cal rux­oli­tinib in atopic der­mati­tis, but gets slapped with JAK warn­ing

In­cyte has made a pret­ty pen­ny with its JAK in­hibitor rux­oli­tinib over the years, but on Tues­day the drug crossed a new thresh­old.

Julie Block

The FDA ap­proved a top­i­cal for­mu­la­tion of the drug for mild-to-mod­er­ate atopic der­mati­tis, In­cyte an­nounced Tues­day af­ter­noon, giv­ing the Wilm­ing­ton, DE-based com­pa­ny a new ar­row in its rux­oli­tinib quiver. The drug, which will be mar­ket­ed as Opzelu­ra, is the first top­i­cal JAK in­hibitor ap­proved in the US and is in­di­cat­ed for AD pa­tients aged 12 and up who strug­gle to con­trol their dis­ease on oth­er pre­scrip­tion creams.

“It can be hard for peo­ple to ful­ly ap­pre­ci­ate how dif­fi­cult AD can be and the tremen­dous im­pact it has on pa­tients,” said Julie Block, CEO of the Na­tion­al Eczema As­so­ci­a­tion, in a state­ment. “The chron­ic itch is dif­fi­cult to cope with and re­lat­ed sleep is­sues can be ex­haust­ing.”

An In­cyte spokesper­son told End­points News lat­er Wednes­day morn­ing that the whole­sale ac­qui­si­tion cost for Opzelu­ra will be set at $1,950 per 60 gram tube.

Tues­day’s ap­proval al­so came with the black box warn­ing seen across the JAK class of drugs, high­light­ing risks of se­ri­ous in­fec­tions, heart at­tack, stroke or car­diac death.

Rux­oli­tinib has mor­phed in­to a block­buster for In­cyte since it gar­nered its first ap­proval as an oral treat­ment for myelofi­bro­sis back in 2011. The drug con­tin­ued to rack up FDA en­dorse­ments ever since, get­ting nods for poly­cythemia ve­ra in 2014 and acute graft-ver­sus-host dis­ease in 2019.

In these in­di­ca­tions, the drug is mar­ket­ed as Jakafi in the US and as Jakavi by No­var­tis else­where. Jakafi net­ted $995 mil­lion in rev­enue through the first half of 2021, main­tain­ing some growth but al­so tak­ing sales hits due to the Covid-19 pan­dem­ic, In­cyte said.

But In­cyte has been push­ing to move rux­oli­tinib in­to a top­i­cal for­mu­la­tion for a while as well. By treat­ing mild and mod­er­ate AD with a cream, pa­tients can more eas­i­ly treat their af­fect­ed ar­eas than with an oral drug. The top­i­cal for­mu­la­tion is al­so in de­vel­op­ment for vi­tili­go, an­oth­er skin con­di­tion that can re­sult in the loss of pig­men­ta­tion.

The ap­proval will al­so give Re­gen­eron and Sanofi’s Dupix­ent some com­pe­ti­tion in the eczema field. In­cyte is hop­ing it can ad­vance Opzelu­ra on ease of use, giv­en that Dupix­ent is ad­min­is­tered by in­jec­tion. The com­pa­ny will have a tough task ahead, how­ev­er, as Dupix­ent pulled in near­ly $1.5 bil­lion in sales in 2021’s sec­ond quar­ter alone.

At the very least, In­cyte has hoped top­i­cal rux­oli­tinib can prove a more ap­peal­ing al­ter­na­tive to cor­ti­cos­teroids, the stan­dard of care in mild-to-mod­er­ate AD. Tues­day’s ap­proval came on the ba­sis of two Phase III stud­ies that com­pared the cream to a place­bo, with pa­tients see­ing at least a two-point im­prove­ment on an in­ves­ti­ga­tor as­sess­ment and a re­duc­tion in itch from base­line af­ter eight weeks.

Peak sales es­ti­mates for the top­i­cal drug have ranged from $300 mil­lion to $1.1 bil­lion by 2025.

This sto­ry has been up­dat­ed with pric­ing in­for­ma­tion for Opzelu­ra. 

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.

Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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