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

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Car­olyn Bertozzi (Illustration: Assistant editor Kathy Wong for Endpoints News)

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

Carolyn Bertozzi, predicted by some to become a Nobel laureate, clinched one of the world’s top awards in the wee hours of Wednesday, winning the Nobel Prize in Chemistry alongside a repeat winner and a Copenhagen researcher.

The Stanford professor, Morten Meldal of University of Copenhagen and 2001-awardee K. Barry Sharpless of Scripps shared the prize equally. The Nobel is sometimes split in quarters and/or halves.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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