AbbVie petitions trade commission to ban Alvotech’s Humira biosimilar; Cytokinetics licenses heart drug to Chinese partner

The Ab­b­Vie/Alvotech de­ba­cle on a Hu­mi­ra biosim­i­lar has tak­en yet an­oth­er turn — es­ca­lat­ing ten­sions be­tween the two biotechs.

The phar­ma gi­ant filed a com­plaint with the US In­ter­na­tion­al Trade Com­mis­sion on Fri­day, try­ing to pre­vent Alvotech from sell­ing a low­er cost ver­sion of Ab­b­Vie’s Hu­mi­ra, an an­ti-TNF drug that treats rheuma­toid arthri­tis, anky­los­ing spondyli­tis and Crohn’s dis­ease, among oth­er ail­ments.

In the com­plaint, the drug­mak­er says that Alvotech mis­ap­pro­pri­at­ed trade se­crets, and is ask­ing the Com­mis­sion to per­ma­nent­ly ban Alvotech from do­ing any­thing with the biosim­i­lar in the Unit­ed States.

Alvotech CEO Róbert Wess­man blast­ed Ab­b­Vie’s move.

‘This ac­tion by Ab­b­Vie – which repack­ages the mer­it­less al­le­ga­tions from a case that was thrown out of court ear­li­er this year – is a sign of Ab­b­Vie’s weak­ness and con­cern that Alvotech’s ef­forts to bring a low­er-cost of­fer­ing to mar­ket will ex­pose Ab­b­Vie’s long-stand­ing abuse of the patent/le­gal sys­tem,’ Wess­man said in a state­ment to End­points News.

Hu­mi­ra has been a well-known cash cow for Ab­b­Vie and one of the best sell­ing drugs of all time. The drug brought in more than $19.8 bil­lion in rev­enue last year, ac­count­ing for more than 40% of Ab­b­Vie’s to­tal rev­enue that year. — Paul Schloess­er

Cy­to­ki­net­ics teams up with Shang­hai biotech Ji Xing, nets $70M in near-term

South San Fran­cis­co biotech Cy­to­ki­net­ics has ex­pand­ed its part­ner­ship with Ji Xing Phar­ma­ceu­ti­cals — a Shang­hai biotech backed by in­vest­ment firm RTW in­vest­ments — and reached a deal to de­vel­op and com­mer­cial­ize Cy­to­ki­net­ics’ ome­cam­tiv mecar­bil as a treat­ment of heart fail­ure with re­duced ejec­tion frac­tion (HFrEF) in Chi­na, Hong Kong, Macau and Tai­wan.

The two com­pa­nies had first part­nered up in Ju­ly 2020 on Cy­to­ki­net­ics’ ex­per­i­men­tal drug afi­camten, once known as CK-274 and de­signed to treat hy­per­trophic car­diomy­opathies.

Ome­cam­tiv mecar­bil, orig­i­nal­ly de­vel­oped by Cy­to­ki­net­ics and then part of a $75 mil­lion deal with Am­gen in 2007, was dumped by Am­gen just over a year ago af­ter the Phase III tri­al GALAC­TIC-HF study missed its sec­ondary end­point — re­duc­tion of car­dio­vas­cu­lar death. Up un­til the Phase III tri­al, the drug had been through 11 Phase I stud­ies with over 300 pa­tients and sev­en Phase II stud­ies with over 1,400 pa­tients since 2005.

Cy­to­ki­net­ics is set to re­ceive $70 mil­lion soon, $50 mil­lion from Ji Xing in up­front and near-term pay­ments and $20 mil­lion from RTW as pro­ceeds for the sale of com­mon stock. Cy­to­ki­net­ics will be el­i­gi­ble to re­ceive up to $330 mil­lion from Ji Xing in ad­di­tion­al mile­stone pay­ments plus tiered roy­al­ties on the net sales of the drug in those Asian mar­kets.

‘We are pleased to ex­pand our cur­rent re­la­tion­ship with Ji Xing to now in­clude ome­cam­tiv mecar­bil,’ said Cy­to­ki­net­ics CEO and pres­i­dent Robert Blum. — Paul Schloess­er

With €300M grant, No­vo Nordisk to open new stem cell re­search cen­ter

No­vo Nordisk Foun­da­tion has pledged €300 mil­lion (about $339 mil­lion) to cre­ate a new stem cell re­search cen­ter.

Dubbed re­NEW, the in­ter­na­tion­al cen­ter will be a con­sor­tium of three in­sti­tu­tions: the Uni­ver­si­ty of Copen­hagen, Den­mark, Mur­doch Chil­dren’s Re­search In­sti­tute, Aus­tralia, and Lei­den Uni­ver­si­ty Med­ical Cen­ter, the Nether­lands. Melis­sa Lit­tle, a pro­fes­sor at Mur­doch, has been ap­point­ed CEO of the part­ner­ship and will lead the ini­tia­tive as ex­ec­u­tive di­rec­tor. The gov­ern­ing hub will be based at the Uni­ver­si­ty of Copen­hagen.

‘Stem cell med­i­cine tru­ly promis­es to be a game chang­er when it comes to ad­dress­ing some of the ma­jor health chal­lenges fac­ing the world to­day,’ said Mads Krogs­gaard Thom­sen, CEO of the No­vo Nordisk Foun­da­tion. ‘With the es­tab­lish­ment of this new Cen­ter, the aim is not just to fur­ther stem cell-based re­search through in­ter­na­tion­al col­lab­o­ra­tions, but al­so to strength­en the path­way from sci­en­tif­ic dis­cov­ery to tar­get­ed out­come, whether in the form of new med­ical tech­nol­o­gy or new forms of treat­ment for the ben­e­fit of pa­tients.’

With ex­change pro­grams and joint tech­nol­o­gy plat­forms built in, the cen­ter aims to en­cour­age re­search in­to the re­gen­er­a­tion of stem cells, fund drug screen­ing projects and study the com­bi­na­tion of gene edit­ing and stem cell tech­nolo­gies.

Lit­tle added that the in­ter­na­tion­al col­lab­o­ra­tion will bring to­geth­er ex­ten­sive tech­ni­cal and clin­i­cal trans­la­tion ex­per­tise in ser­vice of po­ten­tial new drugs based on hu­man stem cell mod­els, cell and tis­sue ther­a­pies as well as gene ther­a­pies.

‘Build­ing on the stem cell re­search ex­cel­lence that ex­ists with­in all part­ner in­sti­tu­tions, the Cen­ter will reach a crit­i­cal mass that is re­quired for trans­lat­ing fun­da­men­tal dis­cov­er­ies in­to stem cell med­i­cine,’ she said in a state­ment. — Am­ber Tong

AR­M­GO Phar­ma has raised $35M around lead mol­e­cule in car­diac and skele­tal mus­cle dis­eases

AR­M­GO Phar­ma, a small New York biotech, has raised $35 mil­lion in a fi­nanc­ing led by For­bion, joined by VCs Pon­tif­ax and Kur­ma Part­ners.

As part of the raise, AR­M­GO is adding sev­er­al peo­ple to the biotech’s board: Geert-Jan Mul­der and Dmitrij Hristodor­ov from For­bion, Iy­ona Ra­jko­mar from Pon­tif­ax and Pe­ter Neubeck from Kur­ma.

Ac­cord­ing to the biotech, the raise will fund fur­ther de­vel­op­ment of lead as­set ARM210 to treat cat­e­cholamin­er­gic poly­mor­phic ven­tric­u­lar tachy­car­dia or CPVT, a rare form of ven­tric­u­lar tachy­car­dia and sud­den death caused by mu­ta­tions in the ryan­odine re­cep­tor 2 (RyR2). The drug is al­so be­ing de­vel­oped for oth­er car­diac and skele­tal mus­cle in­di­ca­tions, ac­cord­ing to the biotech.

The in­vest­ment will fund Phase II clin­i­cal stud­ies to eval­u­ate ARM210 for CPVT, and ac­cord­ing to the biotech, those stud­ies will start by the end of the year. These stud­ies will build on an on­go­ing Phase Ib tri­al in pa­tients with mu­ta­tions in RyR1 (RyR1 re­lat­ed my­opa­thy) at the NIH.

AR­M­GO will ini­tial­ly aim to de­vel­op ARM210 in CPVT to pro­vide clin­i­cal proof-of-con­cept, which will fur­ther de-risk de­vel­op­ing ARM210 for oth­er dis­eases, the com­pa­ny said. — Paul Schloess­er

Ap­tose Bio­Sciences throws in the tow­el on AP­TO-253, six years af­ter FDA clin­i­cal hold

Ap­tose Bio­sciences is done with AP­TO-253.

The low-pro­file San Diego and Toron­to biotech made the an­nounce­ment to­day af­ter re­view­ing the prod­uct pro­file and per­for­mance of the on­col­o­gy drug, the com­pa­ny said. And for next steps, it plans to pri­or­i­tize oth­er can­di­dates in its pipeline, such as ki­nome in­hibitors HM43239 and lux­ep­tinib.

‘AP­TO-253 re­mains an in­ter­est­ing prod­uct that has demon­strat­ed MYC re­pres­sion, which cre­ates op­tion­al­i­ty across the wider on­col­o­gy spec­trum. Mov­ing for­ward, we plan to ex­plore avail­able strate­gic al­ter­na­tives for this com­pound,’ said Ap­tose CEO, chair­man and pres­i­dent William Rice.

Ap­tose had giv­en AP­TO-253 to the first pa­tient back in Jan­u­ary 2015 in a dose-es­ca­la­tion study in­volv­ing two types of blood can­cers: re­lapsed or re­frac­to­ry acute myeloid leukemia and high risk myelodys­plas­tic syn­dromes, with up to 15 pa­tients in each group. Not­ing a prob­lem with in­fu­sion at a pre­lim­i­nary re­view, then linked to ‘chem­istry and man­u­fac­tur­ing based is­sues,’ the com­pa­ny sus­pend­ed the tri­al in No­vem­ber 2015 be­fore the FDA came down with the hold, which was lift­ed in June 2018. — Paul Schloess­er
https://endpts.com/abbvie-petitions-trade-commission-to-ban-alvotechs-humira-biosimilar-cytokinetics-licenses-heart-drug-to-chinese-partner/