Skyrizi, a key drug in Ab­b­Vie’s post-Hu­mi­ra fu­ture, has added an­oth­er feath­er to its cap.

On Tues­day, the IL-23 in­hibitor emerged su­pe­ri­or in a head-to-head 327-pa­tient tri­al against No­var­tis’ dom­i­nant Cosen­tyx in pa­tients with mod­er­ate-to-se­vere plaque pso­ri­a­sis.

Da­ta showed Skyrizi in­duced sig­nif­i­cant­ly high­er rates of skin clear­ance com­pared to Cosen­tyx, meet­ing the pri­ma­ry goal of su­pe­ri­or­i­ty with at least a 90% im­prove­ment from base­line in the Pso­ri­a­sis Area and Sever­i­ty In­dex (PASI 90) at week 52. Over­all, 87% of Skyrizi-treat­ed pa­tients hit PASI 90, ver­sus 57% of Cosen­tyx-treat­ed pa­tients at the one year mark.

The oth­er main goal of non-in­fe­ri­or­i­ty at week 16 — 74% of Skyrizi pa­tients achieved PASI 90 com­pared to 66% of Cosen­tyx pa­tients — was al­so met. Skyrizi al­so eclipsed Cosen­tyx on all sec­ondary end­points, in­clud­ing PASI 100, and PASI 75.

In the fall of 2017, Skyrizi 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.

These head-to-head stud­ies are key to es­tab­lish­ing Skyrizi’s po­si­tion in a crowd­ed mar­ket, which in­cludes Hu­mi­ra, No­var­tis’ an­ti-IL17 Cosen­tyx, J&J’s an­ti-IL23 Trem­fya, an­ti-IL12/23 Ste­lara, as well as Lil­ly’s 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,” SVB Leerink’s Ge­of­frey Porges wrote in a note last year.

“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.”

Skyrizi was ap­proved in April 2019. Ab­b­Vie paid Boehringer In­gel­heim $595 mil­lion up­front to li­cense rights to the drug, known chem­i­cal­ly as risankizum­ab, in ear­ly 2016. Eval­u­ate has pegged Skyrizi as the num­ber 3 block­buster on its list of heavy­weight drugs launched 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.

Last Au­gust, Lil­ly’s Taltz beat J&J’s Trem­fya in a head-to-head pso­ri­a­sis study. In 2018, J&J ran its own head-to-head pso­ri­a­sis tri­al against Cosen­tyx — and came out with da­ta that showed Trem­fya su­per­seded No­var­tis’ dom­i­nant ri­val.

So­cial im­age: Ab­b­Vie

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.