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

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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Paul Hudson, Sanofi CEO (via Getty)

Sanofi's $20B buy­out of Gen­zyme pays off again with Eu­ro­pean OK for first Nie­mann-Pick drug

Sanofi CEO Paul Hudson has made clear his intention to develop new rare disease drugs and broaden his company’s offerings. That effort leaped forward on Friday with the EMA’s signing off on the company’s — and the EU’s — first drug to treat the non-central nervous system manifestations of the rare and debilitating Niemann-Pick disease.

The enzyme replacement therapy, developed to replace patients’ deficient or defective enzyme, known as acid sphingomyelinase, was first developed by Genzyme, which Sanofi acquired for more than $20 billion in 2011. That acquisition has also helped Sanofi pull in sales in the field of MS.

Proac­tive­ly pre­vent­ing short­ages: New FDA guid­ance spells out which drugs re­quire risk man­age­ment plans

As the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday published new draft guidance spelling out how to proactively assess risks to manufacturing processes and supply chains, while understanding the market’s vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, reaching a low in 2015 and 2016, thanks in part to a new law’s enactment, known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.