Anx­ious to fill Hu­mi­ra-sized rev­enue hole ahead of US patent cliff, Ab­b­Vie hits the ground run­ning with FDA ap­proval for Skyrizi

With the loom­ing cloud of los­ing US patent pro­tec­tion for its mega-block­buster Hu­mi­ra, Ab­b­Vie needs all the help it can get to fill the gap­ing $20 bil­lion hole the flag­ship au­toim­mune dis­ease drug will leave in its cof­fers. On Tues­day, the com­pa­ny se­cured the FDA ap­proval of an IL-23 in­hibitor, Skyrizi, that is ex­pect­ed to go some way in re­plen­ish­ing that rev­enue stream: $4 bil­lion to $5 bil­lion in peak an­nu­al sales by Ab­b­Vie’s es­ti­mate — al­though that may be dif­fi­cult in the in­tense­ly com­pet­i­tive field it is set to en­ter.

Ab­b­Vie paid Boehringer In­gel­heim $595 mil­lion up­front to li­cense rights to the drug, known chem­i­cal­ly as risankizum­ab, in ear­ly 2016. In the fall of 2017, the in­ject­ed drug was eval­u­at­ed against J&J’s Ste­lara and its own Hu­mi­ra in a pso­ri­a­sis study — and emerged vic­to­ri­ous, hand­some­ly out­pac­ing the ri­val drugs in clear­ing pso­ri­a­sis. Japan be­came the first re­gion to sanc­tion the use of Skyrizi last month.

More than 8 mil­lion Amer­i­cans have pso­ri­a­sis — mak­ing it one of the most preva­lent au­toim­mune dis­eases in the Unit­ed States, ac­cord­ing to the Na­tion­al Pso­ri­a­sis Foun­da­tion. The dis­ease is char­ac­ter­ized by an un­bri­dled im­mune sys­tem and wide­spread in­flam­ma­tion that caus­es painful, itchy plaques any­where on the skin.

Set for US launch in ear­ly May, Skyrizi will en­ter a crowd­ed mar­ket. Hu­mi­ra con­tin­ues to dom­i­nate de­spite the in­tro­duc­tion of new­er bi­o­log­ics, in­clud­ing No­var­tis’ $NVS an­ti-IL17 Cosen­tyx, J&J’s $JNJ an­ti-IL23 Trem­fya and an­ti-IL12/23 Ste­lara, as well as Lil­ly’s $LLY an­ti-IL17 Taltz.

Skyrizi is not the first pure IL-23 in­hibitor to be ap­proved — Trem­fya was ap­proved in 2017 and Ilumya in 2018. But the Ab­b­Vie drug has a dos­ing ad­van­tage over Trem­fya — it is ad­min­is­tered every 12 weeks, ver­sus once every two months for Trem­fya, SVB Leerink’s Ge­of­frey Porges said on Wednes­day, not­ing that oth­er pso­ri­a­sis bi­o­log­ics in ad­di­tion to the oral Ote­zla gen­er­at­ed a com­bined $11.1 bil­lion in 2018 sales.

This does not in­clude sales of an­ti-TN­Fs in pso­ri­a­sis, which should de­crease as pa­tients move to these new, more ef­fi­ca­cious ther­a­pies. These prod­ucts al­so all achieved $500 mil­lion – $1 bil­lion in the sec­ond year of launch, which is like­ly to al­so be achieved by Skyrizi. Over­all bi­o­log­ics are still used in on­ly 30% of the mod­er­ate to se­vere pso­ri­a­sis pop­u­la­tion, (per JNJ in 2017), and Ab­b­Vie’s Skyrizi should ben­e­fit from both best-in-cat­e­go­ry ef­fi­ca­cy (i.e. mar­ket share gains) and the con­tin­ued rapid mar­ket ex­pan­sion.”

The main­te­nance dose for Skyrizi will car­ry a list price of $59,000, which is low­er than the most wide­ly-pre­scribed bi­o­log­ic treat­ments for mod­er­ate-to-se­vere plaque pso­ri­a­sis, an Ab­b­Vie spokesper­son told End­points News.

The drug is ex­pect­ed to win EU ap­proval lat­er this year, and is al­so be­ing eval­u­at­ed for Crohn’s dis­ease, pso­ri­at­ic arthri­tis and ul­cer­a­tive col­i­tis.

“(D)es­pite be­ing po­si­tioned as a best-in-class op­tion, risankizum­ab failed in a proof-of-con­cept anky­los­ing spondyli­tis study, rais­ing ad­di­tion­al ques­tions over its pro­file” Bar­clays an­a­lysts said in March.

Boehringer will re­ceive undis­closed roy­al­ties on sales of the prod­uct, and in ad­di­tion is el­i­gi­ble to get up to $1.6 bil­lion for de­vel­op­ment and reg­u­la­to­ry mile­stones, a por­tion of which has like­ly been paid al­ready, Porges not­ed.

Eval­u­ate has pegged Skyrizi as the num­ber 3 block­buster on its list of heavy­weight drugs launch­ing in 2019, es­ti­mat­ing the drug could earn more than $2 bil­lion in 2024 — a far cry from Ab­b­Vie’s home­grown es­ti­mate of $4 bil­lion to $5 bil­lion in peak sales. Porges has fore­cast ad­just­ed peak an­nu­al sales of $3 bil­lion.

The oth­er can­di­date ex­pect­ed to fill the Hu­mi­ra gap is Ab­b­Vie’s oral JAK1 in­hibitor upadac­i­tinib for rheuma­toid arthri­tis. The com­pa­ny $AB­BV has high hopes for the treat­ment, pro­ject­ing peak sales of $6.5 bil­lion, which was re­ward­ed pri­or­i­ty re­view by the FDA in Feb­ru­ary. The agency is ex­pect­ed to make its de­ci­sion by the third quar­ter of 2019.

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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