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

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

A new court ruling has strengthened Amgen’s grip on the IP estate around Enbrel, keeping biosimilars of the autoimmune and inflammatory drug at bay until 2029.

Novartis, the patent challenger, isn’t throwing in the towel yet. In a statement noting the failed appeal, its generics division Sandoz noted its reviewing options, “including potential appeal to US Supreme Court.”

It’s been almost four years since the FDA approved Erelzi, Sandoz’s copycat version of Enbrel. While sales of the Pfizer-partnered drug in the US — the market Amgen is in charge of — have dipped slightly during that time, it remains a solid megablockbuster with 2019 revenue slightly above $5 billion.

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.