Sanofi, Re­gen­eron etch out an­oth­er PhI­II vic­to­ry for Dupix­ent, eas­ing se­vere itch and clear­ing le­sions

Sanofi and Re­gen­eron can boast of an­oth­er in­flam­ma­to­ry dis­ease where Dupix­ent has proven ef­fec­tive.

The best-sell­ing drug, which tar­gets both IL-4 and IL-13, has de­liv­ered a clean sweep in a Phase III tri­al for pruri­go nodu­laris, a chron­ic dis­ease char­ac­ter­ized by itch so in­tense that it can af­fect pa­tients’ sleep and psy­chol­o­gy. Thick skin le­sions can cov­er most of the body.

On the pri­ma­ry end­point, 37% of pa­tients tak­ing Dupix­ent saw a clin­i­cal­ly mean­ing­ful re­duc­tion in itch com­pared to 22% of those on place­bo (p=0.0216) at week 12. All sec­ondary end­points were al­so met, in­clud­ing clear­ance of skin le­sions and im­prove­ment in qual­i­ty of life.

Al­though the win came as lit­tle sur­prise to an­a­lysts, ex­ecs were sure to high­light its sig­nif­i­cance — not just in ef­fi­ca­cy but al­so safe­ty.

George Yan­copou­los

For the first time, ac­cord­ing to Re­gen­eron pres­i­dent and CSO George Yan­copou­los, a sys­temic ther­a­py was able to ad­dress de­bil­i­tat­ing symp­toms with­out broad­ly sup­press­ing the im­mune sys­tem.

“Pruri­go nodu­laris is an un­der­diag­nosed dis­ease with im­mense phys­i­cal and emo­tion­al bur­den for the 74,000 peo­ple in the U.S. who are un­able to con­trol their dis­ease with top­i­cal steroids and oth­er­wise do not have an ap­proved treat­ment op­tion,” he said in a state­ment. “These pa­tients are left to cope with se­vere itch­ing and painful nod­ules that, in turn, sig­nif­i­cant­ly im­pair one’s qual­i­ty of life with many re­sort­ing to im­muno­sup­pres­sants and some to an­ti­de­pres­sants.”

John Reed

John Reed, Sanofi’s glob­al head of R&D, added that the da­ta will play a part in re­shap­ing the un­der­stand­ing of type 2 in­flam­ma­to­ry dis­ease — an um­brel­la that al­so cov­ers sev­er­al of Dupix­ent’s ap­proved in­di­ca­tions, in­clud­ing atopic der­mati­tis and asth­ma.

“These da­ta are an im­por­tant step for­ward in fur­ther­ing our knowl­edge of the role that tar­get­ing IL-4 and IL-13 can play in the treat­ment of skin dis­eases that cause ex­treme itch,” said Reed, not­ing that near­ly all of the pa­tients had se­vere itch go­ing in­to the study and “40% had 100 or more nod­ules cov­er­ing their body.”

The PRIME2 study en­rolled a to­tal of 160 pa­tients, 78 of whom were ran­dom­ized to the Dupix­ent arm.

At 24 weeks, 58% of the drug arm saw a clin­i­cal­ly mean­ing­ful re­duc­tion in itch com­pared to 20% of place­bo pa­tients (p<0.0001); Dupix­ent pa­tients were near­ly three times as like­ly to achieve clear or al­most clear skin (45% ver­sus 16%, p<0.0001); and pa­tients on treat­ment al­so ex­pe­ri­enced greater im­prove­ments in mea­sures of health-re­lat­ed qual­i­ty of life, skin pain and symp­toms of anx­i­ety and de­pres­sion, al­though those num­bers were not spelled out.

For an­a­lysts, the re­sults add weight to the da­ta wall Sanofi and Re­gen­eron have been build­ing around its megablock­buster, which brought in $2.76 bil­lion in the first of the year.

“Man­age­ment be­lieves that there is con­sid­er­able room for growth, and we agree that there is no near-term end to the prod­uct’s atopic march with pos­i­tive Phase 3 re­sults in CSU and ad­di­tion­al read­outs in pruri­go nodu­laris (PN), eosinophilic esophagi­tis, and pe­di­atric atopic der­mati­tis lat­er this year,” Bri­an Sko­r­ney of Baird wrote in an Au­gust note. “While a num­ber of com­pet­i­tive prod­ucts are look­ing to pig­gy­back on Dupi’s suc­cess, we don’t see any ma­jor risks to this fran­chise giv­en how broad­ly safe and ef­fec­tive it has been shown to be.”

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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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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Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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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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