News brief­ing: Cosen­tyx shows ear­ly pos­i­tive signs in pso­ri­at­ic arthri­tis; Pfiz­er's PhI­Ib for car­dio drug trig­gers $75M mile­stone

No­var­tis’ block­buster Cosen­tyx is seek­ing ap­proval in an­oth­er in­di­ca­tion, and the com­pa­ny re­port­ed pos­i­tive ear­ly Phase II­Ib re­sults Thurs­day.

Look­ing to re­duce joint lin­ing in­flam­ma­tion in pso­ri­at­ic arthri­tis, Cosen­tyx saw ben­e­fits against place­bo af­ter 12 weeks. Though No­var­tis didn’t pro­vide any num­bers in this ear­ly look, the com­pa­ny said the drug showed “sig­nif­i­cant ben­e­fit” on its way to meet­ing the pri­ma­ry end­point.

No­var­tis is as­sess­ing the spe­cif­ic in­flam­ma­tion Cosen­tyx is try­ing to treat, known as syn­ovi­tis, us­ing an ul­tra­sound test. The drug­mak­er ex­pects to re­lease the full 24-week da­ta in 2021.

Cosen­tyx was No­var­tis’ best­seller in the first half of this year, tal­ly­ing near­ly $1.9 bil­lion in glob­al sales. It al­so sold more than any oth­er No­var­tis prod­uct in all of 2019, net­ting the Swiss phar­ma more than $3.5 bil­lion last year, up 25% from 2018.

The drug, an IL-17A in­hibitor, is cur­rent­ly ap­proved across four in­di­ca­tions pso­ri­a­sis, pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis and non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis. It’s fac­ing po­ten­tial R&D com­pe­ti­tion in the pso­ri­a­sis space from Ab­b­Vie’s Hu­mi­ra suc­ces­sor Skyrizi and UCB’s bimek­izum­ab. — Max Gel­man

Io­n­is bags $75M mile­stone as Pfiz­er kicks off PhI­Ib for car­dio drug

Pfiz­er has treat­ed the first pa­tient of a Phase IIb study of vu­panors­en, the ANGPTL3-tar­get­ing an­ti­sense oligonu­cleotide it li­censed from Io­n­is a year ago.

For Io­n­is, that means re­ceiv­ing a $75 mil­lion mile­stone pay­ment and sit­ting back to let the phar­ma gi­ant han­dle every­thing from here on out.

The goal is to en­roll 260 pa­tients with el­e­vat­ed non-HDL cho­les­terol and triglyc­erides who are re­ceiv­ing a sta­ble dose of a statin. The drug met the pri­ma­ry end­point of sig­nif­i­cant re­duc­tions in triglyc­erides lev­els in Phase IIa, which tar­get­ed those with hy­per­triglyc­eridemia, type 2 di­a­betes and non-al­co­holic fat­ty liv­er dis­ease (NAFLD).

In the new tri­al, in­ves­ti­ga­tors will be eval­u­at­ing mul­ti­ple dos­es and fo­cus on change in non-HDL-C. — Am­ber Tong

Cal­i­for­nia cy­tom­e­try play­er rais­es $120M in Se­ries D

Cytek Bio­sciences has a whole new heap of cash to play with.

The Fre­mont, CA-based biotech has closed a $120 mil­lion Se­ries D round, it an­nounced Thurs­day, that will be used to ex­pand its glob­al in­fra­struc­ture. Cytek fo­cus­es its re­search on flow cy­tom­e­try, a cell analy­sis tech­nique that Cytek hopes can pro­vide bet­ter di­ag­nos­tic tools for can­cer and cell bi­ol­o­gy.

“We are com­mit­ted to ad­vanc­ing the scope, reach and ca­pa­bil­i­ties of flow cy­tom­e­try — and to pro­vid­ing re­searchers and clin­i­cians around the globe with the tools they need to im­prove pa­tient treat­ments,” CEO Wen­bin Jiang said in a state­ment.

Thurs­day’s round was co-led by RA Cap­i­tal and Hill­house Cap­i­tal, with Or­biMed and LYFE Cap­i­tal al­so chip­ping in. RA and Hill­house have al­so joined Cytek’s board of di­rec­tors.

Cytek says its pro­pri­etary plat­form of­fers a more com­plete pic­ture of all the dif­fer­ent cel­lu­lar play­ers in the im­mune sys­tem than pre­vi­ous cy­tom­e­try ef­forts. — Max Gel­man

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

EU re­port­ed­ly eye­ing vac­cines deal for mon­key­pox out­break; Nas­daq tells Mereo to get stock price up or face delist­ing

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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