Ab­b­Vie's Skyrizi hangs No­var­tis' Cosen­tyx out to dry in head-to-head pso­ri­a­sis study

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

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

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.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

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.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

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.