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.

As first re­port­ed by STAT News, 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

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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89bio to net $275M from stock of­fer­ing; As­sem­bly Bio to pause work on one HBV in­hibitor pro­gram

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.