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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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An­oth­er Avastin biosim­i­lar joins the par­ty as Roche's grip on the mar­ket loosens

Avastin has attracted quite the crowd of biosimilars in recent years, and one more pharma company has elbowed its way in.

Regulators on Wednesday approved Celltrion’s biosimilar Vegzelma in six cancer types, including metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.

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Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.

Sanofi us­es cre­ative cam­ou­flage in physi­cian-tar­get­ed cam­paign for po­ten­tial can­cer bio­mark­er

As Sanofi studies a new kind of cancer drug, it’s prepping physicians for its potential biomarker expression.

Sanofi’s tusamitamab ravtansine is an antibody-drug conjugate (ADC) that targets CEACAM5-expressing tumors and is currently in a Phase III study to treat advanced non-small cell lung cancer. A companion diagnostic test is also under development, said François-Xavier Etaix, Sanofi’s global brand lead for CEACAM5, in an email interview.

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